Status:
COMPLETED
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV-1
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses o...
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 trial for ...
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 (extrasystoli, 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 post-hysterectomy or post-surgical 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 :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00838760
Start Date
February 1 2009
End Date
October 1 2009
Last Update
April 28 2010
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