Japanese Phase I of GSK1605786

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Drug: GSK1605786; Drug: GSK1605786 Placebo	Phase 1

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
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
Actual Study Start Date :	July 22, 2010
Actual Primary Completion Date :	October 6, 2010
Actual Study Completion Date :	October 6, 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Plasma concentration [ Time Frame: up to 72h post dose ]

Secondary Outcome Measures :

1. Adverse envents [ Time Frame: up to 72h post dose ]
2. Vital signe [ Time Frame: up to 72h post dose ]
3. Clinical laboratory [ Time Frame: up to 72h post dose ]
4. 12 lead ECG [ Time Frame: up to 72h post dose ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01611805 History of Changes
Other Study ID Numbers:	114472
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