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Japanese Phase I of GSK1605786

NCT01611805 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-14

No results posted yet for this study

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

Interventions

DRUG

GSK1605786

Opaque Swedish orange body and cap.

DRUG

GSK1605786 Placebo

Opaque Swedish orange body and cap.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-22
Primary Completion
2010-10-06
Completion
2010-10-06

Countries

  • Australia

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611805 on ClinicalTrials.gov