TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.

NCT00736905 | Completed Phase 1

• 1 other identifier: CR007465
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) after a single dose and after repeated administration of TMC278 administered once daily for 11 days in subjects with mild or moderate hepatic impairment (impaired liver function), compared with healthy control subjects. Furthermore the short-term safety and tolerability (how well the body tolerates the drug) of TMC278 will be assessed.

Conditions

HIV; AIDS; Hepatic Impairment

Keywords

TMC278-TiDP6-C130; TMC278-C130; healthy volunteer; hepatic impairment; HIV Infections

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to assess the single-dose and steady-state pharmacokinetics of TMC278 in subjects with mild or moderate hepatic impairment compared to matched healthy control subjects.

Secondary Outcomes (1)

• The secondary objective of this study is to assess the short-term safety and tolerability of TMC278 in subjects with mild or moderate hepatic impairment compared to matched healthy control subjects.

Interventions

TMC278 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included
• Only for subjects with hepatic impairment: History of hepatic disease
• Documented liver cirrhosis
• Mild or moderate liver function impairment
• Only for healthy control subjects: Healthy on the basis of a physical examination, medical history, electrocardiogram (ECG), vital signs and the results of blood biochemistry and hematology tests and a urinalysis
• Matched to a subject with hepatic impairment with regards to sex, age (± 5 yrs), and BMI (± 15%).

You may not qualify if:

• No positive HIV test
• No females, except if postmenopausal since more than 2 years, or posthysterectomy, or post tubal ligation
• No barbiturate, amphetamine, recreational or narcotic drug use
• No use of more than 1 unit of alcoholic beverages per day
• No positive urine drug test
• No active gastrointestinal disease (with the exception of liver cirrhosis in the hepatically impaired subjects), cardiovascular, neurologic, psychiatric, metabolic, renal, respiratory, inflammatory, or infectious disease
• No currently significant diarrhea, gastric stasis, or constipation
• No history of any significant skin disease
• No previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication administered in this trial (i.e. TMC278)
• Not previously participated in more than 1 trial with TMC125, TMC120 and/or TMC278 or having developed a rash, erythema or urticaria while participating in a trial with the aforementioned compounds
• No participation in an investigational drug trial within 60 days prior to the first administration of trial medication
• No donation of blood or plasma or significant blood loss within the 60 days preceding the first administration of trial medication
• No vulnerable subjects
• No subjects who are not able to read or write
• Only for subjects with hepatic impairment: No acute or active hepatitis

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; 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; Slow 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: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 28, 2010

Record last verified: 2010-04