Last updated: 11/04/2018 06:09:08

A healthy volunteer study to investigate the relative bioavailability of two forms of GSK598809 capsules.

GSK study ID
DAN111283
See study documents
Clinicaltrials.gov ID
NCT00728897
EudraCT ID
2008-001967-12
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours

Secondary outcomes:

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.

Timeframe: Up to 96 hours

Interventions:
Drug: GSK598809 new formulation
Drug: GSK598809 old formulation
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Substance Dependence
Product
GSK598809
Collaborators
Not applicable
Study date(s)
July 2008 to July 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • Inclusion:
  • Healthy as determined by responsible physician.
Inclusion and exclusion criteria
Inclusion 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 location(s)

Location
Status
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Location
GSK Investigational Site
London, United Kingdom, SE1 1YR
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-29-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study DAN111283 can be found on the GSK Clinical Study Register.
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