Bioequivalence and Food Effect Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F; Drug: Formulation G

• Registration Number: NCT00495274
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to select the formulation with the optimal pharmacokinetic profile for an hypnotic drug to further develop in the market.

Detailed Description

A single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate the pharmacokinetics, safety and tolerability of 6 different formulations of SB-649868 30 mg (Part A) and the effect of food on the selected formulation of SB-649868 pharmacokinetic (Part B) in healthy male volunteers

Study Timeline

• Study First Submitted: 2007-06-29
• Study First Submitted QC: 2007-06-29
• Study Start: 2007-07-02
• Study First Posted: 2007-07-03
• Primary Completion: 2007-09-26
• Study Completion: 2007-09-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-04
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy male subjects	Formulation D	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.
Healthy male subjects	Formulation E	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.
Healthy male subjects	Formulation A	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.
Healthy male subjects	Formulation B	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.
Healthy male subjects	Formulation G	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.
Healthy male subjects	Formulation C	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.
Healthy male subjects	Formulation F	In Part A each subject will participate in six sessions and will be administered, in randomized order, single doses of five new formulations (formulation B, C, D, E and F) of SB-649868 30 milligrams (mg), in fasted state and a single dose of the original formulation (formulation A), after a standard Food and Drug Administration (FDA) High-Fat breakfast. All dosing sessions will be separated by a washout session of at least 5 ± 2 days after each dose. In Part B a single dose of the selected SB-649868 30 mg formulation will be administered after a standard FDA High-Fat breakfast.

Primary Outcome Measures

Name	Time	Method
-Part A: SB-649868 levels of 6 formulation predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose	predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose
-Part B: SB-649868 levels of selected formulation after food at the same timepoints as in Part A	predose, 0.5, 1, 1.5, 2,3,4,5,6,8,12 and 24hours post-dose

Secondary Outcome Measures

Name	Time	Method
-Romberg heel-to-toe test at discharge	at discharge
-AE, Lab values and cardiovascular monitoring throughout study participation	throughout study participation
Pharmacodynamic endpoint: Bond Lader Visual Analogue Scale (VAS) score	pre-dose, 0.5, 1, 2, 4, 6 hours post-dose on Day 1
-Cognitive functions predose, 0.5, 1, 2, 4, 6 hours post-dose	predose, 0.5, 1, 2, 4, 6 hours post-dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇮🇹 Verona, Veneto, Italy