A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance Dependence |
Drug: GSK598809 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
- 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.
| Enrollment: | 16 |
| Study Start Date: | July 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
-
Drug: GSK598809
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00728897 History of Changes |
| Other Study ID Numbers: | DAN111283 |
| Study First Received: | August 4, 2008 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
Healthy volunteer relative bioavailability. |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013