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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Placebo; Drug: GW685698X

Study type: Interventional

Funder types: Industry

Identifiers

NCT00522678

HZA102928

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36 participants in 3 patient groups

Cohort A

Experimental group

Description:

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.

Treatment:

Drug: GW685698X

Drug: Placebo

Cohort B

Experimental group

Description:

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.

Treatment:

Drug: GW685698X

Drug: Placebo

Cohort C

Experimental group

Description:

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.

Treatment:

Drug: GW685698X

Drug: Placebo