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

April 12, 2012
May 31, 2012
July 2010
October 2010   (final data collection date for primary outcome measure)
Plasma concentration [ Time Frame: up to 72h post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01611805 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Crohn's Disease
  • Drug: GSK1605786
    Opaque Swedish orange body and cap.
  • Drug: GSK1605786 Placebo
    Opaque Swedish orange body and cap.
  • Experimental: GSK1605786 250mg
    Opaque Swedish orange body and cap.
    Intervention: Drug: GSK1605786
  • Placebo Comparator: Placebo
    Opaque Swedish orange body and cap.
    Intervention: Drug: GSK1605786 Placebo
  • Experimental: GSK1605786 500mg
    Opaque Swedish orange body and cap.
    Intervention: Drug: GSK1605786
  • Experimental: GSK1605786 1000mg
    Opaque Swedish orange body and cap.
    Intervention: Drug: GSK1605786
  • Experimental: GSK1605786 500mg in fed
    Opaque Swedish orange body and cap.
    Intervention: Drug: GSK1605786
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2010
October 2010   (final data collection date for primary outcome measure)

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)

Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01611805
114472
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP