Last updated: 11/04/2018 10:09:13
A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population
GSK study ID
OXS109143
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
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
Trial description: The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
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
Timeframe: 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 outcomes:
Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868
Timeframe: within 7-14 days from a single dose of SB-649868
Interventions:
Drug: SB-649868
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Insomnia
Product
SB649868
Collaborators
Not applicable
Study date(s)
July 2009 to November 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Healthy adult and elderly female and male
- Female must be of non-childbearing potential
- Abuse of alcohol or drugs
- Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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