Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

April 24, 2013

Primary Completion Date

July 12, 2013

Study Completion Date

July 12, 2013

Conditions
Cancer
Interventions
DRUG

Afuresertib GC - Fasted State

White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fasted state

DRUG

Afuresertib HPMC capsule - Fasted State

White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fasted state

DRUG

Afuresertib ECT - Fasted State

White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fasted state

DRUG

Afuresertib GC - Fed State

White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fed state

DRUG

Afuresertib HPMC capsule - Fed State

White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fed state

DRUG

Afuresertib ECT - Fed State

White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fed state

Trial Locations (1)

3004

GSK Investigational Site, Melbourne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01827644 - Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers | Biotech Hunter | Biotech Hunter