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

A Single-centre, Open Label, Single-dose, Four Parallel Cohorts Study to Investigate the Pharmacokinetics, Safety and Tolerability of SB-649868 10mg in Healthy Female Non-childbearing Potential, Healthy Male and in Healthy Elderly Subjects

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534872

Enrollment

Registered

2007-09-26

Start date

2007-10-31

Completion date

2007-10-31

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

4 Parallel cohorts, Healthy Female, Healthy Elderly, Pharmacokinetic, Safety and Tolerability

Brief summary

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

Interventions

DRUGSB-649868

10 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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	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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026