15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Simvastatin; Drug: Placebo; Drug: SB-649868

Study type: Interventional

Funder types: Industry

Identifiers

NCT00495729

OXS104092

Details and patient eligibility

About

Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.

Enrollment: 36 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 =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
• Healthy as judged by responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator and the Medical Monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
• Subjects will have blood pressure measurements within the normal range for healthy volunteers.

Exclusion criteria

• The subject has a positive pre-study urine drug/ alcohol urine screen.
• A positive pre-study Hepatitis B surface antigen, Hepatitis C antibody, or HIV 1/2 result at the screening visit.
• Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units.
• Subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.

Trial design

36 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin.

Treatment:

Drug: SB-649868

Drug: Simvastatin

Drug: Placebo

Cohort 2

Experimental group

Description:

Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin.

Treatment:

Drug: SB-649868

Drug: Simvastatin

Drug: Placebo

Cohort 3

Experimental group

Description:

Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin.

Treatment:

Drug: SB-649868

Drug: Simvastatin

Drug: Placebo