A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.

NCT ID: NCT00728897

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-02
• Study Completion Date: 2008-07-29

Brief Summary

Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.

Conditions

Substance Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects receiving treatment sequence ABC

Eligible subjects will receive treatment sequence ABC; A= 4x25 milligrams GSK598809 capsule given in fasted state, B= 100 milligrams GSK598809 capsule in given fasted state and C= 100 milligrams GSK598809 capsule given in fed state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.

Group Type: EXPERIMENTAL

GSK598809 new formulation

Intervention Type: DRUG

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

GSK598809 old formulation

Intervention Type: DRUG

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Subjects receiving treatment sequence ACB

Eligible subjects will receive treatment sequence ACB; A= 4x25 milligrams GSK598809 capsule given in fasted state, C= 100 milligrams GSK598809 capsule given in fed state and B= 100 milligrams GSK598809 capsule in given fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.

Group Type: EXPERIMENTAL

GSK598809 new formulation

Intervention Type: DRUG

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

GSK598809 old formulation

Intervention Type: DRUG

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Subjects receiving treatment sequence BAC

Eligible subjects will receive treatment sequence BAC; B= 100 milligrams GSK598809 capsule in given fasted state, A= 4x25 milligrams GSK598809 capsule given in fasted state and C= 100 milligrams GSK598809 capsule given in fed state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.

Group Type: EXPERIMENTAL

GSK598809 new formulation

Intervention Type: DRUG

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

GSK598809 old formulation

Intervention Type: DRUG

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Subjects receiving treatment sequence BCA

Eligible subjects will receive treatment sequence BCA; B= 100 milligrams GSK598809 capsule in given fasted state, C= 100 milligrams GSK598809 capsule given in fed state and A= 4x25 milligrams GSK598809 capsule given in fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.

Group Type: EXPERIMENTAL

GSK598809 new formulation

Intervention Type: DRUG

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

GSK598809 old formulation

Intervention Type: DRUG

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Subjects receiving treatment sequence CAB

Eligible subjects will receive treatment sequence CAB; C= 100 milligrams GSK598809 capsule given in fed state, A= 4x25 milligrams GSK598809 capsule given in fasted state and B= 100 milligrams GSK598809 capsule in given fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.

Group Type: EXPERIMENTAL

GSK598809 new formulation

Intervention Type: DRUG

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

GSK598809 old formulation

Intervention Type: DRUG

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Subjects receiving treatment sequence CBA

Eligible subjects will receive treatment sequence CBA; C= 100 milligrams GSK598809 capsule given in fed state, B= 100 milligrams GSK598809 capsule in given fasted state and A= 4x25 milligrams GSK598809 capsule given in fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.

Group Type: EXPERIMENTAL

GSK598809 new formulation

Intervention Type: DRUG

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

GSK598809 old formulation

Intervention Type: DRUG

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Interventions

GSK598809 new formulation

GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.

Intervention Type: DRUG

GSK598809 old formulation

GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy as determined by responsible physician.
• Male or female between 18 to 65 years old.
• Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.
• Males that agree to use appropriate method of contraception for appropriate amount of time.
• Neither too fat nor too thin.
• Capable of giving written informed consent and being compliant with requirements within the informed consent.

Exclusion:

• Any current medical or psychiatric illness.
• Any history of chronic medical or psychiatric illnesses.
• Previous or current alcohol or drug abuse/dependence including nicotine.
• Female subjects must not be breastfeeding or been breastfeeding for a month.
• Serum prolactin exceeding normal range.
• Personal or family history of prolonged QTc syndrome.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

DAN111283

Identifier Type: -

Identifier Source: org_study_id