A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population

GlaxoSmithKline

Overview

The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Insomnia

Interventions

SB-649868DRUG

10 mg

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

INCLUSION CRITERIA: * Healthy adult and elderly female and male * Female must be of non-childbearing potential * Body weight =50 kg EXCLUSION CRITERIA: * Abuse of alcohol or drugs * Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV * Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication * Smoking history of = 10 cigarettes a day in the last three months * History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases * Participation in clinical trial during the previous 6 months

Outcomes

Primary Outcomes

Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Time frame: single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Secondary Outcomes

Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868

Time frame: within 7-14 days from a single dose of SB-649868

Data from ClinicalTrials.gov

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