Japanese Phase I of GSK1605786

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01611805
First received: April 12, 2012
Last updated: May 31, 2012
Last verified: May 2012
  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 Blind (Subject, Investigator)
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 ] [ Designated as safety issue: No ]

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

Enrollment: 30
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 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

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611805

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01611805     History of Changes
Other Study ID Numbers: 114472
Study First Received: April 12, 2012
Last Updated: May 31, 2012
Health Authority: Australia: Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on August 26, 2014