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

NCT00522678 | Completed Phase 1

• 1 other identifier: HZA102928
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Cohort A

EXPERIMENTAL

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.

Drug: GW685698X; Drug: Placebo

Cohort B

EXPERIMENTAL

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.

Drug: GW685698X; Drug: Placebo

Cohort C

EXPERIMENTAL

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.

Drug: GW685698X; Drug: Placebo

Interventions

GW685698X DRUG

Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS

Cohort A; Cohort B; Cohort C

Placebo DRUG

Subject will receive Placebo matching GW685698X via DISKUS.

Cohort A; Cohort B; Cohort C

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• History of breathing problems

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Results for study HZA102928 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

Asthma

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: August 30, 2007
• Study Start: February 15, 2007
• Primary Completion: April 25, 2007
• Study Completion: April 25, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)