Japanese Phase I of GSK1605786

Phase 1

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: GSK1605786; Drug: GSK1605786 Placebo

• Registration Number: NCT01611805
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-22
• Primary Completion: 2010-10-06
• Study Completion: 2010-10-06
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK1605786 250mg	GSK1605786	Opaque Swedish orange body and cap.
Placebo	GSK1605786 Placebo	Opaque Swedish orange body and cap.
GSK1605786 500mg	GSK1605786	Opaque Swedish orange body and cap.
GSK1605786 1000mg	GSK1605786	Opaque Swedish orange body and cap.
GSK1605786 500mg in fed	GSK1605786	Opaque Swedish orange body and cap.

Primary Outcome Measures

Name	Time	Method
Plasma concentration	up to 72h post dose

Secondary Outcome Measures

Name	Time	Method
Adverse envents	up to 72h post dose
Clinical laboratory	up to 72h post dose
Vital signe	up to 72h post dose
12 lead ECG	up to 72h post dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Randwick, New South Wales, Australia