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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014