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This study has been withdrawn prior to enrollment.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

September 24, 2007
June 10, 2010
October 2007
October 2007   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00534872 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
Drug: SB-649868
10 mg
Other Name: SB-649868
Experimental: SB649868
10 mg
Intervention: Drug: SB-649868
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
26
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00534872
OXS109143
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP