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

NCT00854204 | Completed Phase 1

• 1 other identifier: CR015763
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-I

Keywords

Innovation-TiFP4-C101; Innovation-C101; Innovation; TMC114/TMC41629; controlled-release coformulations; immediate-release coformulation; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma levels of TMC114 and TMC41629 will be determined up to 72 hours after administration.

Secondary Outcomes (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).

Interventions

TMC114; TMC41629 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Interventions

Darunavir

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals Limited Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: March 3, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 28, 2010

Record last verified: 2010-04