Japanese Phase I of GSK1605786

NCT01611805 | Completed Phase 1

• 1 other identifier: 114472
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Plasma concentration

  up to 72h post dose

Secondary Outcomes (4)

• 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

Study Arms (5)

GSK1605786 250mg

EXPERIMENTAL

Opaque Swedish orange body and cap.

Drug: GSK1605786

Placebo

PLACEBO COMPARATOR

Opaque Swedish orange body and cap.

Drug: GSK1605786 Placebo

GSK1605786 500mg

EXPERIMENTAL

Opaque Swedish orange body and cap.

Drug: GSK1605786

GSK1605786 1000mg

EXPERIMENTAL

Opaque Swedish orange body and cap.

Drug: GSK1605786

GSK1605786 500mg in fed

EXPERIMENTAL

Opaque Swedish orange body and cap.

Drug: GSK1605786

Interventions

GSK1605786 DRUG

Opaque Swedish orange body and cap.

GSK1605786 1000mg; GSK1605786 250mg; GSK1605786 500mg; GSK1605786 500mg in fed

GSK1605786 Placebo DRUG

Opaque Swedish orange body and cap.

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Links

• Results for study 114472 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: June 5, 2012
• Study Start: July 22, 2010
• Primary Completion: October 6, 2010
• Study Completion: October 6, 2010
• Last Updated: June 14, 2017

Record last verified: 2017-06

Locations

AU (1)