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Completed

NCT Number: NCT00495729

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

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-649868

Drug

Subjects will receive SB-649868 5 mg, 25 mg tablets orally 1 hour prior to simvastatin administration.

Placebo

Drug

Subjects will receive matching placebo tablets to SB-649868 orally 1 hour prior to simvastatin administration.

simvastatin

Drug

Subjects will receive Simvastatin 10 mg tablets orally.

Primary outcomes

  1. -AE, Lab values and cardiovascular monitoring after the SD and 14 days RD period (15 days)

    Time frame: after the SD and 14 days RD period (15 days)

  2. - SB649868 levels on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)

    Time frame: on days -7, 1, 4, 7 and 14 (pre-dose and post-dose)

  3. - Simvastatine and Beta-idroxy-simvastatine levels on days -10,1,4,7 and 15

    Time frame: on days -10,1,4,7 and 15

Secondary outcomes

  1. Cognitive functions, sleep profile and appetite assessment on days -7, 7 and 14.

    Time frame: on days -7, 7 and 14.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Single-blind, Randomised, Placebo-controlled, 15 Day Repeated-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-649868 and Its Interaction With the CYP3A4 Isoenzyme in Healthy Male Subjects.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 3, 2007
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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