Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078

PHASE1CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Cachexia
Interventions
DRUG

GSK2881078

GSK2881078 hot melt solutions, ranging in concentration from 0.05 mg/g to 50 mg/g, will be prepared by weighing drug substance directly into specific quantities of the hot melt vehicle solution. Subjects will be administered GSK2881078 (dose for Cohort 1: 0.75 mg for females and 1.5 mg for males) hot melt solution within capsule orally with water.

DRUG

Placebo

Subjects will be administered as hot melt vehicle placebo within capsule orally with water.

DRUG

Itraconazole

Subjects will be administered as two capsules of itraconazole 100 mg (200 mg) orally with water.

Trial Locations (1)

66211

GSK Investigational Site, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02567773 - Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic Study of GSK2881078 and Study to Evaluate the Effect of CYP3A4 Inhibition on PK of GSK2881078 | Biotech Hunter | Biotech Hunter