Bioequivalence and Food Effect Study in Healthy Volunteers

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Formulation E; Drug: Formulation C; Drug: Formulation A; Drug: Formulation F; Drug: Formulation G; Drug: Formulation D; Drug: Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00495274

OXS105205

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male subjects aged between 18 and 65 years of age inclusive.
• Body weight and BMI within the protocol ranges.
• Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
• Circulating levels of LH, FSH and testosterone within the normal reference range.
• Signed and dated written informed consent.
• The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria

• Positive pre-study urine drug screen and alcohol breath test.
• Positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV ½ result.
• Abuse of alcohol as per protocol criteria.
• Consumption of prohibited food and drink as per protocol.
• Subject who is not prepared to eat the standard meals provided by the site.
• Use of prescription or non-prescription drugs 1 or 2 weeks before the first dose of study medication.
• Where participation in study would result in donation of blood in excess of 500mL within a 56 day period.
• History or presence of allergy to the study drug or drugs of this class, or a history of other allergy.
• Smoking history in the last three months as per protocol.
• An unwillingness of male subjects to follow contraception methods as per protocol.
• History or presence of significant psychiatric, respiratory or gastrointestinal illnesses, hepatic or renal diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• The subject is unable or unwilling to abstain from strenuous physical activity in the 48 hours before screening and in the 48 hours before and the 48 hours after the treatment period.
• Current or previous (within 6 months) participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Healthy male subjects

Experimental group

Description:

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.

Treatment:

Drug: Formulation A

Drug: Formulation G

Drug: Formulation D

Drug: Formulation E

Drug: Formulation F

Drug: Formulation C

Drug: Formulation B