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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
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland

Study Description
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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 of two drugs, TMC114 and TMC41629. There will be 1 single oral intake (intake by mouth) of each of the 3 preparations. The study will also investigate the safety of use and the potential side effects of TMC114 and TMC41629, and determine the circulating levels of both compounds in your blood over time (pharmacokinetics), after a single intake.

Condition or disease Intervention/treatment Phase
HIV-I Drug: TMC114; TMC41629 Phase 1

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 healthy volunteer know the name of the study medication), each healthy volunteer will receive a single dose of TMC114/TMC41629, in 3 subsequent sessions, Treatment A, Treatment B and Treatment C. Each capsule is equivalent to a dose of 200 mg of TMC114 and 23.67 mg of TMC41629. Treatment A (immediate-release formulation) will serve as reference formulation. All medication intakes will be orally and in fasted conditions.The study duration is at least 19 days, excluding screening and follow-up visits with three single intakes with 72 hours follow-up per intake. Each volunteer will receive a single dose of each formulation. TMC114/TMC41629 is formulated as an oral immediate-release hard-gelatin capsule, as an oral gastro-resistant hard-gelatin capsule, enteric-coated and as an oral gastro-resistant hard-gelatin capsule, colon-targeted. Each capsule is equivalent to a dose of 200 mg of TMC114 and 23.67 mg of TMC41629.

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Plasma levels of TMC114 and TMC41629 will be determined up to 72 hours after administration.

Secondary Outcome Measures :
  1. To determine short-term safety and tolerability of TMC114/TMC41629 following administration of 3 single oral doses (formulated as different coformulations of TMC114/TMC41629).

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Limited Clinical Trial Tibotec Pharmaceutical Limited
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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