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

NCT ID: NCT00534872

Last Updated: 2015-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SB649868

10 mg

Group Type EXPERIMENTAL

SB-649868

Intervention Type DRUG

10 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SB-649868

10 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GSK

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OXS109143

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Disturbed Sleep Model Study.
NCT00440323 COMPLETED PHASE1