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

This study has been withdrawn prior to enrollment.
(The study was stoppend before recruitment start for preclinical safety finding in rats.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00534872
First received: September 24, 2007
Last updated: June 10, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: SB-649868
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
Study Start Date: October 2007
Estimated Study Completion Date: October 2007
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB649868
10 mg
Drug: SB-649868
10 mg
Other Name: SB-649868

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534872

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00534872     History of Changes
Other Study ID Numbers: OXS109143
Study First Received: September 24, 2007
Last Updated: June 10, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by GlaxoSmithKline:
4 Parallel cohorts
Healthy Female
Healthy Elderly
Pharmacokinetic
Safety and Tolerability

ClinicalTrials.gov processed this record on April 16, 2014