Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects.

NCT01476046 | Completed Phase 1

• 1 other identifier: 110951
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are.

Conditions

Respiratory Disorders

Keywords

Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (10)

• Occurance of adverse events.

  Number and type of adverse events recorded during study.

  From start of screening until 84 days after completion of single dose (Part A subjects) or first dose (Part B subjects).

• Change from baseline in blood pressure.

  Systolic and diastolic blood pressure values before and after dosing completion.

  From start of screening until 28 days after completion of single or repeat dosing.

• Change from baseline in heart rate.

  Heart rate before and after dosing completion.

  From start of screening until 28 days after completion of single or repeat dosing.

• Change from baseline in respiration rate.

  Respiration rate before and after dosing completion.

  From start of screening until 28 days after completion of single or repeat dosing.

• Change from baseline in body temperature.

  Body temperature before and after dosing completion.

  From start of screening until 28 days after completion of single or repeat dosing.

• Change from baseline in heart function.

  Holter recording.

  For 24hrs during screening, then for 1 hour before dosing to 24 hours after dosing starts (in Part A subjects only, except for cohort 7).

• Change from baseline in heart function

  Lead II cardiac telemetry.

  From 1 hour before dosing to 12 hours after dosing starts for each dose.

• Change from baseline in heart function.

  12-lead ECG recording.

  From start of screening until 28 days after completion of single or repeat dosing.

• Change from baseline in lung function.

  FEV1 and FVC measurements.

  From start of screening until 28 days after completion of single or repeat dosing.

• Change from baseline in laboratory safety data.

  Clinical chemistry, haematology and routine urinalysis.

  From start of screening until 28 days after completion of single or repeat dosing.

Secondary Outcomes (6)

• Plasma pharmacokinetics of GSK1995057

  From the first day of dosing until 48 hours after the completion of dosing.

• Urine pharmacokinetics of GSK1995057

  From 1 hour before the only dose until 48 hours after the dose.

• Bronchoalveolar lavage fluid (BALF) (saline flushed into and then collected from a lung) pharmacokinetics.

  At 2 hrs after the completion of the only dose.

• Effect of GSK1995057 on host immunity and immunological function

  From the day before dosing starts to 28 days after dosing completion.

• Effects of GSK1995057 on host immunity and immunological function

  At 2 hrs after the completion of the only dose.

Study Arms (2)

GSK1995057

EXPERIMENTAL

Single intravenous dose

Drug: GSK1995057 single dose

Placebo

PLACEBO COMPARATOR

Single intravenous dose

Drug: Placebo

Interventions

GSK1995057 single dose DRUG

Single intravenous dose

GSK1995057

Placebo DRUG

Single intravenous dose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as determined by a responsible and experienced physician.
• Male or female between 18 and 55 years of age inclusive
• A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and elevated FSH as per the local laboratory guidelines.
• Normal creatinine clearance values at screening
• Male subjects must agree to use one of the study specific contraception methods
• Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
• Normal lung function at screening.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Available to complete all study assessments.
• Able to read, comprehend and write English at a sufficient level to complete study elated materials.

You may not qualify if:

• A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
• A positive pre-study drug/alcohol screen.
• Evidence of previous or active mycobacterium tuberculosis complex infection
• Recent history of and/or a positive test for Toxoplasma consistent with active oxoplasmosis infection.
• A positive test for influenza A/B taken within 7 days before dosing.
• Current evidence or history of an influenza-like illness.
• Corrected QT interval (QTcF) \>450msec from ECG readings.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
• The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits.
• Subjects with a smoking history of \>10 cigarettes per day in the last 3 months.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or exposure to more than four new chemical or biological entities within 12 months prior to the first dosing day.
• Subjects having received any type of vaccination within 3 weeks of the anticipated dosing start or are expected to be vaccinated within 3 weeks after the last dose.
• Current evidence of ongoing or acute infection, history of repeated or chronic significant infections or history of serious infection within three months of dosing.
• Subjects who have asthma or a history of asthma, COPD, other respiratory conditions or recurrent infections (a subject who suffered from childhood asthma but not as an adult may be included provided they fulfil other entry criteria).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Harrow, Middlesex, United Kingdom

Location

Related Links

• Results for study 110951 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Respiration Disorders; Acute Lung Injury; Respiratory Distress Syndrome

Interventions

GSK1995057

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Injury; Lung Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: November 22, 2011
• Study Start: March 8, 2011
• Primary Completion: June 17, 2012
• Study Completion: June 17, 2012
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)