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
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ClinicalTrials.gov Identifier: NCT00854204 |
Recruitment Status
:
Completed
First Posted
: March 3, 2009
Last Update Posted
: April 28, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-I | Drug: TMC114; TMC41629 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I, Open-label, 3-way Crossover Trial in Healthy Male Volunteers 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 |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |
- Plasma levels of TMC114 and TMC41629 will be determined up to 72 hours after administration.
- To determine short-term safety and tolerability of TMC114/TMC41629 following administration of 3 single oral doses (formulated as different coformulations of TMC114/TMC41629).

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854204
Study Director: | Tibotec Pharmaceuticals Limited Clinical Trial | Tibotec Pharmaceutical Limited |
ClinicalTrials.gov Identifier: | NCT00854204 History of Changes |
Other Study ID Numbers: |
CR015763 |
First Posted: | March 3, 2009 Key Record Dates |
Last Update Posted: | April 28, 2010 |
Last Verified: | April 2010 |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
Innovation-TiFP4-C101 Innovation-C101 Innovation TMC114/TMC41629 |
controlled-release coformulations immediate-release coformulation Pharmacokinetics |
Additional relevant MeSH terms:
Darunavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |