A Blinded, Dose Ascending Study to Assess the Pharmacokinetics, Safety and Tollerability of Repeat Inhaled Doses of Nebulised GW870086X in Healthy Adult Male Volunteers.

NCT01160003 | Completed Phase 1

• 1 other identifier: 113209
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover study in healthy adult male volunteers. The primary objective of the study is to assess the pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The secondary objective is to assess the safety and tolerability of repeat doses of nebulised GW870086X.

Conditions

Asthma

Keywords

ACTH stimulation test; Pharmacokinetics; Nebules; Cortisol

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax)

  3 months

Secondary Outcomes (5)

• Adverse Events

  3 months

• Clinically relevant changes in safety parameters:Clinical laboratory tests (clinical chemistry, haematology, urinalysis), 12-Lead ECG data; including QT, QTc, HR, QRS and RR intervals, Vital signs: systolic and diastolic blood pressure, pulse rate

  3 months

• Serum cortisol weighted mean over 24 hours

  3 months

• Urine cortisol excretion over 24 hours

  3 months

• ACTH stimulation test (Period 3 only)

  3 months

Study Arms (3)

Treatment Period 1

EXPERIMENTAL

5mg of GW870086X or placebo will be given once daily for 14 days.

Drug: GW870086X; Drug: Placebo

Treatment Period 2

EXPERIMENTAL

GW870086X (5mg or 8.75mg) or placebo will be given once daily for 14 days. In a randomised dose escalating manor following on from treatment period 1.

Drug: GW870086X; Drug: Placebo

Treatment Period 3

EXPERIMENTAL

8.75mg of GW870086X or placebo will be given once daily for 14 days.

Drug: GW870086X; Drug: Placebo

Interventions

GW870086X DRUG

5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.

Treatment Period 1; Treatment Period 2; Treatment Period 3

Placebo DRUG

placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.

Treatment Period 1; Treatment Period 2; Treatment Period 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose.
• Body weight, men ≥ 50 kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Single QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.

You may not qualify if:

• A positive pre-study 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 Gilbert's syndrome or asymptomatic gallstones).
• A positive pre-study drug/alcohol screen.
• A positive test for HIV antibody.
• History of regular alcohol consumption within 6 months of the study defined as:
• For EU sites: an average weekly intake of \>21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
• 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: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.
• Subjects who are kept due to regulatory or juridical order in an institution.
• Subjects who are in military service.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 14050, Germany

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 113209 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Asthma

Interventions

GW870086X

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: July 29, 2010
• Primary Completion: November 5, 2010
• Study Completion: November 5, 2010
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)