Japanese Phase I of GSK1605786 - Full Text View

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:

Genetics Home Reference related topics: Crohn disease

U.S. FDA Resources

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 (Adult)
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


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 September 26, 2016