Japanese Phase I of GSK1605786

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Crohn's Disease

Treatments

Drug: GSK1605786 Placebo

Drug: GSK1605786

Study type

Interventional

Funder types

Industry

Identifiers

NCT01611805

114472

Details and patient eligibility

About

This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.

Enrollment

30 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Japanese as
Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity -Male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
Body weight =>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive).

Exclusion criteria

Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 5 patient groups, including a placebo group

GSK1605786 250mg

Experimental group

Description: