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TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation

This study has been completed.
Information provided by:
Tibotec Pharmaceuticals, Ireland Identifier:
First received: December 18, 2008
Last updated: June 8, 2011
Last verified: April 2010
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet. In addition, the effect of each formulation of TMC278 will be evaluated in patients in the fasted and fed states and the palatability (how the drug tastes) of each formulation will be assessed. Finally, the safety and tolerability of each formulation of TMC278 will be assessed throughout the study.

Condition Intervention Phase
Drug: TMC278
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Randomized, Crossover Trial in Healthy Adults to Compare the Oral Bioavailability of TMC278 From Three Concept Pediatric Formulations (Solution, Suspension, Granules) With That From the Adult Phase III Tablet Formulation.

Resource links provided by NLM:

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • For each treatment session, full pharmacokinetic profiles will be measured up to 168 hours post-dosing

Secondary Outcome Measures:
  • Safety and tolerability will be monitored throughout the trial. Palatability of the 3 concept formulations will be assessed.

Enrollment: 36
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:
This is an open-label (both investigator and volunteer knows the name of the assigned study medication), randomized (study medication will be assigned by chance) cross-over study in healthy adults to compare the rate and the extent of absorption of TMC278 when administered as a single 25 mg dose of the 3 concept pediatric formulations (solution [10 mg/mL], suspension [5 mg/mL], granules [2.5 mg/g]), under fed and fasted conditions, to that when administered as the 25 mg TMC278 Phase III tablet formulation, under fed conditions, in healthy adults and to assess the effect of food on the bioavailability of TMC278 after a single 25 mg dose of the concept pediatric TMC278 formulations in healthy adults. The palatability of the 3 concept formulations will be assessed in a fasted state by use of a questionnaire and a visual analog scale. The short-term safety and tolerability of TMC278 following administration of 3 single oral doses of 25 mg, formulated as one of the concept pediatric formulations (under fed and fasted conditions) and as the Phase III tablet (under fed conditions), in healthy adults will be evaluated. TMC278 25 mg formulated as a solution, suspension, granules, or tablet will be administered orally (by mouth). Each volunteer will receive on the first day of one treatment session one TMC278 25 mg tablet. On the first day of the other sessions they receive a single dose of TMC278 25 mg formulated as a the solution, a suspension or granules.

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

Inclusion Criteria:

  • Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
  • 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 signed voluntarily before the first trial-related activity
  • Able to comply with protocol requirements
  • Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram, vital signs, and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.

Exclusion Criteria:

  • A positive HIV-1 or -2 test at trial screening
  • Female, except if postmenopausal since more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
  • One or more risk factors for QTc prolongation
  • Currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT00812292

Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

Additional Information: Identifier: NCT00812292     History of Changes
Other Study ID Numbers: CR012586
Study First Received: December 18, 2008
Last Updated: June 8, 2011

Keywords provided by Tibotec Pharmaceuticals, Ireland:
concept pediatric formulations of TMC278
HIV Infections

Additional relevant MeSH terms:
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents processed this record on April 21, 2017