Last updated: 11/04/2018 10:08:19
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
GSK study ID
OTB109039
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects
Trial description: A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs
Timeframe: 24 Hours
Secondary outcomes:
Blood tests to study how long the drug stays in your blood
Timeframe: 24 Hours
Interventions:
Enrollment:
42
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Obstetric Labour, Premature, Premature Ejaculation
Product
epelsiban
Collaborators
Not applicable
Study date(s)
October 2007 to April 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Healthy males who are 18 to 45 years of age
- Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
- Alcohol consumption averaging more than 7 drinks per week
- Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy males who are 18 to 45 years of age
- Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
- Non-smokers
Exclusion criteria:
- Alcohol consumption averaging more than 7 drinks per week
- Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
- Any use of prescription drugs or non prescription drugs
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-29-04
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website