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

Primary Purpose

Substance Dependence

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GSK598809 new formulation
GSK598809 old formulation
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring Healthy volunteer, relative bioavailability.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Subjects receiving treatment sequence ABC

Subjects receiving treatment sequence ACB

Subjects receiving treatment sequence BAC

Subjects receiving treatment sequence BCA

Subjects receiving treatment sequence CAB

Subjects receiving treatment sequence CBA

Arm 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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.

Secondary Outcome 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.

Full Information

First Posted
August 4, 2008
Last Updated
August 2, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00728897
Brief Title
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
Official Title
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
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2, 2008 (Actual)
Primary Completion Date
July 29, 2008 (Actual)
Study Completion Date
July 29, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence
Keywords
Healthy volunteer, relative bioavailability.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving treatment sequence ABC
Arm Type
Experimental
Arm 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.
Arm Title
Subjects receiving treatment sequence ACB
Arm Type
Experimental
Arm 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.
Arm Title
Subjects receiving treatment sequence BAC
Arm Type
Experimental
Arm 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.
Arm Title
Subjects receiving treatment sequence BCA
Arm Type
Experimental
Arm 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.
Arm Title
Subjects receiving treatment sequence CAB
Arm Type
Experimental
Arm 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.
Arm Title
Subjects receiving treatment sequence CBA
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
GSK598809 new formulation
Intervention Description
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
Intervention Name(s)
GSK598809 old formulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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