Status:
WITHDRAWN
PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infections
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the safety, tolerability, and plasma pharmacokinetics (i.e., the levels of TMC589337 and TMC589354 circulating in your blood over time) of increasing single or...
Detailed Description
This is a First-in-Human Phase I, double-blind (neither physician or patient knows the name of the assigned study drug), randomized (study medication assigned by chance), placebo-controlled (a group o...
Eligibility Criteria
Inclusion
- Nonsmokers for at least 3 months prior to selection
- Weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form (ICF) signed voluntarily
- Able to comply with protocol requirements
- Healthy on the basis of a pretrial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG).
Exclusion
- Past history of clinically significant heart arrhythmias (extrasystolic, tachycardia at rest)
- having baseline prolongation of QTc interval \> 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT Syndrome)
- Female, except if postmenopausal for more than 2 years, or posthysterectomy or postsurgical sterilization (without reversal operation)
- Currently active clinically relevant or significant underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
- History of clinically relevant skin disease or allergy including drug allergy as well.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00908414
Start Date
May 1 2009
End Date
October 1 2009
Last Update
October 28 2016
Active Locations (1)
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1
Utrecht, Netherlands