Japanese Phase I of GSK1605786

A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: GSK1605786; Drug: GSK1605786 Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSK1605786 250mg; Opaque Swedish orange body and cap.	Drug: GSK1605786; Opaque Swedish orange body and cap.
Placebo Comparator: Placebo; Opaque Swedish orange body and cap.	Drug: GSK1605786 Placebo; Opaque Swedish orange body and cap.
Experimental: GSK1605786 500mg; Opaque Swedish orange body and cap.	Drug: GSK1605786; Opaque Swedish orange body and cap.
Experimental: GSK1605786 1000mg; Opaque Swedish orange body and cap.	Drug: GSK1605786; Opaque Swedish orange body and cap.
Experimental: GSK1605786 500mg in fed; Opaque Swedish orange body and cap.	Drug: GSK1605786; Opaque Swedish orange body and cap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration	up to 72h post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse envents	up to 72h post dose
Vital signe	up to 72h post dose
Clinical laboratory	up to 72h post dose
12 lead ECG	up to 72h post dose

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2010
• Primary Completion (Actual): October 6, 2010
• Study Completion (Actual): October 6, 2010

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 114472