Status:
COMPLETED
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Substance Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00728897
Start Date
July 2 2008
End Date
July 29 2008
Last Update
August 4 2017
Active Locations (1)
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1
GSK Investigational Site
London, United Kingdom, SE1 1YR