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Japanese Phase I of GSK1605786

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611805
First Posted: June 5, 2012
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Drug: GSK1605786 Drug: GSK1605786 Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma concentration [ Time Frame: up to 72h post dose ]

Secondary Outcome Measures:
  • Adverse envents [ Time Frame: up to 72h post dose ]
  • Vital signe [ Time Frame: up to 72h post dose ]
  • Clinical laboratory [ Time Frame: up to 72h post dose ]
  • 12 lead ECG [ Time Frame: up to 72h post dose ]

Enrollment: 30
Actual Study Start Date: July 22, 2010
Study Completion Date: October 6, 2010
Primary Completion Date: October 6, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611805


Locations
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01611805     History of Changes
Other Study ID Numbers: 114472
First Submitted: April 12, 2012
First Posted: June 5, 2012
Last Update Posted: June 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases