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

Overview

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 4×25 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.

Full Title of Study: “An Open Label, Randomised, Single Dose, Three-way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male and Female Volunteers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 29, 2008

Interventions

  • Drug: 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Subjects receiving treatment sequence ABC
    • Eligible subjects will receive treatment sequence ABC; A= 4×25 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.
  • Experimental: Subjects receiving treatment sequence ACB
    • Eligible subjects will receive treatment sequence ACB; A= 4×25 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.
  • Experimental: Subjects receiving treatment sequence BAC
    • Eligible subjects will receive treatment sequence BAC; B= 100 milligrams GSK598809 capsule in given fasted state, A= 4×25 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.
  • Experimental: 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= 4×25 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.
  • Experimental: Subjects receiving treatment sequence CAB
    • Eligible subjects will receive treatment sequence CAB; C= 100 milligrams GSK598809 capsule given in fed state, A= 4×25 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.
  • Experimental: 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= 4×25 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.

Clinical Trial Outcome Measures

Primary Measures

  • Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
    • Time Frame: Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours

Secondary Measures

  • Safety and Tolerability: cardiovascular variables, vital signs, clinical labs, movement scales, prolactin, GH and TSH levels over 96 hours post dosing. Continuous adverse event monitoring from dosing until study conclusions.
    • Time Frame: Up to 96 hours

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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