Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) Imaging

NCT03069989 | Terminated Phase 1 Results

• 2 other identifiers: 2047152016-003674-41
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

GSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that single nebulized doses of 1-3000 micrograms (mcg) GSK3008348 in healthy volunteers were well tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol. The proposed study is a 2-cohort study of single doses, intended to evaluate the safety, tolerability and PK of the drug in participants with IPF not currently treated with pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort 1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will be designed to further explore safety and to provide additional information on the target engagement profile of GSK3008348. The total duration of the study will be up to 62 days.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Tolerability; IPF; PET imaging; Idiopathic Pulmonary Fibrosis; Safety; Pharmacokinetics; Double-blind

Outcome Measures

Primary Outcomes (35)

• Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose

  The change in the uptake of \[18F\]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data, was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348. The per-Protocol population consisted of all participants in the Intent-to-Treat population who comply with the protocol and that had at least one evaluable PET measurement post-dose.

  Baseline (pre-dose) and 30 minutes post-dose

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Intent-to-Treat population consisted of all randomized participants who received at least one dose of study treatment.

  Up to 62 days

• Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count

  Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC Count

  Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Hematology Parameter: Hemoglobin

  Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Hematology Parameter: Hemoglobin

  Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Hematology Parameter: Hematocrit

  Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Hematology Parameter: Hematocrit

  Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin

  Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin

  Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume

  Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume

  Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count

  Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count

  Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase

  Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase

  Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Chemistry Parameters: Albumin and Total Protein

  Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Chemistry Parameters: Albumin and Total Protein

  Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine

  Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine

  Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen

  Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen

  Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 1: Number of Participants With Abnormal Urinalysis Results by Dipstick

  Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.

  Baseline (Day -1) and 24 hours post-GSK3008348 dose

• Period 2: Number of Participants With Abnormal Urinalysis Results by Dipstick

  Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.

  Baseline (Day -1), 24 hours post-GSK3008348 dose and Day 15 (follow-up)

• Period 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

  SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Vital Signs: DBP and SBP

  SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)

• Period 1: Change From Baseline in Vital Signs: Heart Rate

  Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Vital Signs: Heart Rate

  Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)

• Period 1: Change From Baseline in Vital Sign: Respiration Rate

  Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Vital Sign: Respiration Rate

  Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)

• Period 1: Change From Baseline in Vital Sign: Temperature

  Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose

• Period 2: Change From Baseline in Vital Sign: Temperature

  Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)

• Period 1: Number of Participants With Abnormal Findings for 12-lead Electrocardiograms (ECG) Parameters

  Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

  Pre-dose (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose

• Period 2: Number of Participants With Abnormal Findings for 12-lead ECG Parameters

  Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

  Pre-dose (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge), Day 2 (pre-PET scan) and Day 15 (follow-up)

• Period 1: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)

  FEV1 and FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 and FVC was measured using standard spirometry equipment. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline (Day -1), 1 hour and 24 hours post-GSK3008348 dose

Secondary Outcomes (11)

• Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Time (AUC[0-t]) After Single Dose Administration of GSK3008348

  Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose

• Period 2: AUC(0-t) After Single Dose Administration of GSK3008348

  Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose

• Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3008348

  Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose

• Period 2: AUC(0-infinity) After Single Dose Administration of GSK3008348

  Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose

• Period 1: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3008348

  Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose

Study Arms (4)

Cohort 1 GSK3008348

EXPERIMENTAL

Participants will receive a single nebulized dose of GSK3008348 during each of 2 planned dosing periods and up to 3 microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2.

Drug: GSK3008348; Drug: [18F]-FBA-A20FMDV2

Cohort 1 Placebo

PLACEBO COMPARATOR

Participants will receive a single nebulized dose of placebo during each of 2 planned dosing periods and up to 3 microdose of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2.

Drug: Placebo; Drug: [18F]-FBA-A20FMDV2

Cohort 2 GSK3008348

EXPERIMENTAL

Participants will receive a single nebulized dose of GSK3008348 during each of 2 planned dosing periods and up to 3 microdose administrations of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2.

Drug: GSK3008348; Drug: [18F]-FBA-A20FMDV2

Cohort 2 Placebo

PLACEBO COMPARATOR

Participants will receive a single nebulized dose of placebo during each of 2 planned dosing periods and up to 3 microdose of \[18F\]-FBA-A20FMDV2 for the PET scanning in period 2.

Drug: Placebo; Drug: [18F]-FBA-A20FMDV2

Interventions

GSK3008348 DRUG

Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal.

Cohort 1 GSK3008348; Cohort 2 GSK3008348

Placebo DRUG

Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20mm stopper and aluminium seal.

Cohort 1 Placebo; Cohort 2 Placebo

[18F]-FBA-A20FMDV2 DRUG

Radio-labeled peptide ligand for PET scan. Available as intravenous (IV) infusion, 20 mL.

Cohort 1 GSK3008348; Cohort 1 Placebo; Cohort 2 GSK3008348; Cohort 2 Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male participants aged \>= 50 years, and female participants aged \>=55 years, at the time of signing the informed consent.
• Diagnosis of definite or probable IPF as determined by a responsible and experienced chest physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society Internationale Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias.
• Ambulant and capable of attending outpatient visits.
• FVC \> 50 percent predicted and DLCO \> 40 percent predicted.
• Body weight \>= 45 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg/square meter (inclusive).
• Male and female
• Male participants: A male participant must agree to use contraception as detailed in this protocol during the study and for at least 90 days after the follow up visit, and refrain from donating sperm during this period.
• Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) as defined in the protocol.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• ALT and bilirubin \> 1.5x upper limit of normal (ULN; isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35 percent).
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• QT corrected (QTc) \> 450 milliseconds (msec), or QTc \> 480 msec in participants with Bundle Branch Block.
• Current IPF exacerbation, or upper or lower respiratory tract infection on admission to the clinical unit.
• History of or suffers from claustrophobia, or unable to lie flat and still on their back for up to 2 hrs in the PET scanner.
• Extent of emphysema greater than the extent of fibrotic change on High-Resolution Computed Tomography (HRCT) scan, based on investigator judgment.
• FEV1/FVC ratio \< 0.70 at screening (post-bronchodilator).
• History of sensitivity to the study treatment, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators or Medical Monitor, contraindicates their participation.
• Any current oro-pharygneal disease or disorders as judged by the investigator.
• Currently taking pirfenidone or nintedanib, or received pirfenidone or nintedanib within 30 days of the first dose of study treatment.
• Taken, within 7 days or 5 half-lives (whichever is longer) before the first dose of study treatment, organic anion transporter (OAT) substrates with a narrow therapeutic index (example: methotrexate and tenofovir), vitamins, or dietary or herbal supplements, unless in the opinion of the investigator and sponsor the supplement will not interfere with the study medication.
• Long-term continuous home oxygen therapy (use of oxygen that is only intermittent and for symptom relief is acceptable).
• Participation in a clinical trial and receipt of an investigational medicinal product within the following time period before the first dose in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than 4 new investigational medicinal products within 12 months before the first dose.
• Presence of Hepatitis B surface antigen (HBsAg) at screening, or positive Hepatitis C antibody test result at screening or within 3 months before the first dose of study treatment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

London, SW3 6HP, United Kingdom

Location

GSK Investigational Site

London, WC1E 6JF, United Kingdom

Location

GSK Investigational Site

London, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

GSK3008348

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: June 13, 2017
• Primary Completion: July 4, 2018
• Study Completion: July 18, 2018
• Last Updated: August 12, 2019
• Results First Posted: August 12, 2019

Record last verified: 2019-06

Locations

GB (3)