NCT00728897|CompletedPhase 1

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.

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

DAN111283

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2008

StartedJul 2008

CompletionJul 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Jul 2008

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

27 days study duration

Study Start

First participant enrolled

July 2, 2008

Completed

27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2008

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed

Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

27 days

First QC Date

August 4, 2008

Last Update Submit

August 2, 2017

Conditions

Substance Dependence

Keywords

Healthy volunteerrelative bioavailability.

Outcome Measures

Primary Outcomes (1)

Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
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 (1)

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.
Up to 96 hours

Study Arms (6)

Subjects receiving treatment sequence ABC

EXPERIMENTAL

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.