Status:
COMPLETED
Innovation-TiFP4-C101: A Study to Evaluate the Pharmacokinetics of TMC114 and TMC41629 After a Single Oral Dose of 2 Controlled-release Coformulations as Compared to an Immediate-release Coformulation of TMC114/TMC41629
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV-I
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the bioavailability (the degree to which a drug becomes available in the body after administration) of 3 different pharmaceutical preparations of a combination ...
Detailed Description
TMC41629 is a new investigational drug for the treatment of HIV. TMC114, is also known as Darunavir. In this randomized (study medication assigned by chance), open label trial (investigator and health...
Eligibility Criteria
Inclusion
- Non-smoking for at least 3 months prior to selection
- Normal 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 before the first trial-related activity
- Able to comply with protocol requirements
- Healthy on the basis of a medical evaluation that confirms the absence of any clinically relevant abnormality and includes a physical examination, medical history, the results of blood biochemistry, coagulation, and hematology tests, a urinalysis, vital signs, and a 12-lead electrocardiogram (ECG) (in triplicate) with the following parameters carried out at screening: a. heart rate (HR) between 40 and 100 bpm
- b. QTc interval = 450 ms
- c. QRS interval lower than 120 ms
- d. PR interval = 220 ms.
Exclusion
- Past history of heart arrhythmias
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
- Hepatitis A, B, or C infection or HIV-1 or HIV-2 infection at screening
- Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, or infectious disease
- Any history of significant skin disease and allergy to drugs
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00854204
Start Date
November 1 2008
End Date
January 1 2009
Last Update
April 28 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.