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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Substance Dependence

Treatments: Drug: GSK598809 old formulation; Drug: GSK598809 new formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728897

DAN111283

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 6 patient groups

Subjects receiving treatment sequence ABC

Experimental group

Description:

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.

Treatment:

Drug: GSK598809 old formulation

Drug: GSK598809 new formulation

Subjects receiving treatment sequence ACB

Experimental group

Description:

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.

Treatment:

Drug: GSK598809 old formulation

Drug: GSK598809 new formulation

Subjects receiving treatment sequence BAC

Experimental group

Description:

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.

Treatment:

Drug: GSK598809 old formulation

Drug: GSK598809 new formulation

Subjects receiving treatment sequence BCA

Experimental group

Description:

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.

Treatment:

Drug: GSK598809 old formulation

Drug: GSK598809 new formulation

Subjects receiving treatment sequence CAB

Experimental group

Description:

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.

Treatment:

Drug: GSK598809 old formulation

Drug: GSK598809 new formulation

Subjects receiving treatment sequence CBA

Experimental group

Description:

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.

Treatment:

Drug: GSK598809 old formulation

Drug: GSK598809 new formulation