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

NCT00812292 | Completed Phase 1

• 1 other identifier: CR012586
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pharmacokinetics; Bioavailability; HIV-1

Keywords

TMC278; TMC278-C145; TMC278-TiDP38-C145; concept pediatric formulations of TMC278; HIV Infections

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

TMC278 DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Links

• Phase I, open-label, randomized, crossover trial in healthy adults to compare the bioavailability of 3 concept pediatric formulations of TMC278 to the adult 25 mg Phase III tablet formulation, and to assess the food effect for each concept formulation.

MeSH Terms

Conditions

HIV Infections

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals 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: December 18, 2008
• First Posted: December 22, 2008
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2010-04