Japanese Phase I of GSK1605786

NCT ID: NCT01611805

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-22
• Study Completion Date: 2010-10-06

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

GSK1605786 250mg

Opaque Swedish orange body and cap.

Group Type: EXPERIMENTAL

GSK1605786

Intervention Type: DRUG

Opaque Swedish orange body and cap.

Placebo

Opaque Swedish orange body and cap.

Group Type: PLACEBO_COMPARATOR

GSK1605786 Placebo

Intervention Type: DRUG

Opaque Swedish orange body and cap.

GSK1605786 500mg

Opaque Swedish orange body and cap.

Group Type: EXPERIMENTAL

GSK1605786

Intervention Type: DRUG

Opaque Swedish orange body and cap.

GSK1605786 1000mg

Opaque Swedish orange body and cap.

Group Type: EXPERIMENTAL

GSK1605786

Intervention Type: DRUG

Opaque Swedish orange body and cap.

GSK1605786 500mg in fed

Opaque Swedish orange body and cap.

Group Type: EXPERIMENTAL

GSK1605786

Intervention Type: DRUG

Opaque Swedish orange body and cap.

Interventions

GSK1605786

Opaque Swedish orange body and cap.

Intervention Type: DRUG

GSK1605786 Placebo

Opaque Swedish orange body and cap.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Randwick, New South Wales, Australia

Countries

Australia

Other Identifiers

114472

Identifier Type: -

Identifier Source: org_study_id