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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728897
First Posted: August 6, 2008
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
August 4, 2008
August 6, 2008
August 4, 2017
July 2, 2008
July 29, 2008   (Final data collection date for primary outcome measure)
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 ]
Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
Complete list of historical versions of study NCT00728897 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
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 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Substance Dependence
  • 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.
  • Experimental: 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.
    Interventions:
    • Drug: GSK598809 new formulation
    • Drug: GSK598809 old formulation
  • Experimental: 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.
    Interventions:
    • Drug: GSK598809 new formulation
    • Drug: GSK598809 old formulation
  • Experimental: 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.
    Interventions:
    • Drug: GSK598809 new formulation
    • Drug: GSK598809 old formulation
  • 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= 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.
    Interventions:
    • Drug: GSK598809 new formulation
    • Drug: GSK598809 old formulation
  • Experimental: 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.
    Interventions:
    • Drug: GSK598809 new formulation
    • Drug: GSK598809 old formulation
  • 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= 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.
    Interventions:
    • Drug: GSK598809 new formulation
    • Drug: GSK598809 old formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 29, 2008
July 29, 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00728897
DAN111283
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP