TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278

NCT01031589 | Completed Phase 1

• 1 other identifier: CR016747
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the safety, local tolerability and pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of a single intramuscular injection (injected directly in the muscle) of 300 mg (Panel 1) or 600 mg (Panel 2) of a new long acting form of TMC278. In Panel 3, the safety, local tolerability and pharmacokinetics are being studied after three successive intramuscular injections (single injection on Day1, single injection on Day15 and single injection on Day43) of a selected dose of the same TMC278 LA formulation. The dose of Panel 3 will be determined based on the safety, local tolerability and the pharmacokinetic results obtained in Panel 1 and 2.

Conditions

HIV Infections

Keywords

TMC278-TiDP15-C158; TMC278-C158; TMC278; HIV; Non-nucleoside reverse transcriptase inhibitor; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Rate and extent of absorption of TMC278 following single or three successive IM injections

  Panel 1 and 2 and after injection 2 and 3 in Panel 3: 672 hours; after injection 1 in panel 3: 336 hours.

Secondary Outcomes (2)

• Results of Injection Site evaluations

  Daily for the first week in the study, then weekly for minimally the next 12 weeks.

• Safety Assessments (monitoring AEs, Lab, Vital Signs, ECG parameters)

  Panel 1 and 2: Continuously throughout the 8 study visits; Panel 3: continuously throughout the 14 study visits.

Interventions

TMC278 (Rilpivirine) LA; Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoker for at least 3 months prior to selection
• A BMI of 18.0 to 30.0 kg/m2
• Normal 12-lead electrocardiogram
• Healthy on the basis of physical examination, clinical laboratory tests, medical history and vital signs

You may not qualify if:

• Female, except if postmenopausal for at least 2 years or surgically sterile
• positive urine drug test
• History of clinically relevant skin disease or drug allergy
• Participation in an investigational drug study or having received a vaccine within 30 days prior to the first injection of TMC278 LA or placebo
• Previous participation in a study with oral TMC278, TMC125, TMC120 and/or TMC278 LA

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Publications (1)

• Verloes R, Deleu S, Niemeijer N, Crauwels H, Meyvisch P, Williams P. Safety, tolerability and pharmacokinetics of rilpivirine following administration of a long-acting formulation in healthy volunteers. HIV Med. 2015 Sep;16(8):477-84. doi: 10.1111/hiv.12247. Epub 2015 May 18.

  PMID: 25988676 DERIVED

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: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 20, 2012

Record last verified: 2012-11