Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: GW685698X; Drug: Placebo

• Registration Number: NCT00522678
• Lead Sponsor: GlaxoSmithKline

Brief Summary

GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry powder containing either lactose alone or lactose and cellobiose octaacetate. However, future dry powder GW685698X formulations will contain lactose and magnesium stearate. This study will be the first administration of this new GW685698X dry powder formulation in man and will provide safety and tolerability data to support the further development of this formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-15
• Study First Submitted: 2007-03-07
• Primary Completion: 2007-04-25
• Study Completion: 2007-04-25
• Study First Submitted QC: 2007-08-28
• Study First Posted: 2007-08-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy Volunteers,
• Aged 18-65
• Male and females (females of non-child bearing potential or who meet the contraception criteria).
• BMI - 19-31 kg/m2

Exclusion Criteria

• History of breathing problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C	GW685698X	InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Cohort A	GW685698X	In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Cohort B	GW685698X	In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Cohort B	Placebo	In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Cohort A	Placebo	In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Cohort C	Placebo	InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Vital signs: systolic and diastolic blood pressure (BP), heart rate (HR) 12-lead ECG including QT, QTc, PR and QRS intervals PEFR Laboratory safety tests (clinical chemistry, haematology, urinalysis) Adverse events	Up to Day 16

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) for GW685698X on Day 1 and Day 14. Weighted mean serum cortisol, (0-24 h) on Day 14.	Weighted mean serum cortisol, (0-24 h) on Day 14

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Melbourne, Victoria, Australia