TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.

NCT00741169 | Completed Phase 1

• 1 other identifier: CR015412
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the interactions seen when somebody doses with TMC435350 and Rifampin (commercial form of antibiotic).

Conditions

Hepatitis C; HCV; Tuberculosis; Rifampin; Pharmacokinetics

Keywords

TMC435350-TiDP16-C105; TMC435350-C105; Hepatitis C; HCV; Rifampin

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic (PK) profile of TMC435350

  The following PK parameters will be assessed: C0h on Day 7 of Treatments A and C; and C0h, Cmin, Cmax, tmax, AUC24h, Css,av, FI, λz, t1/2term, Ratio Cmin test/ref, Ratio C0h test/ref, Ratio Cmax test/ref, and Ratio AUC24h test/ref.

  On Day 1, 2, 4, 6, and 7 of Treatments A and C

• Pharmacokinetic (PK) profile of rifampin and 25-deacetylrifampin

  The PK parameter of C0h will be assessed on Day 1, 2, 4 and 6 of Treatments B and C, and the PK parameters of C0h, Cmin, Cmax, tmax, AUC24h, Css,av, FI, λz, t1/2term, Ratio Cmin test/ref, Ratio C0h test/ref , Ratio Cmax test/ref , Ratio AUC24h test/ref on Day 7 of Treatments B and C.

  On Day 1, 2, 4, 6, and 7 of Treatments B and C

Secondary Outcomes (1)

• The number of participants reporting adverse events as a measure of safety and tolerability.

  Up to 30 to 35 days after the last intake of study drug.

Study Arms (6)

Treatment Sequence ABC

EXPERIMENTAL

Participants will be randomized to each of the 6 different treatment sequences. Each treatment sequence will consist of Treatment A (TMC435350 200 mg once daily for 7 days), Treatment B (rifampin 600 mg once daily for 7 days), and Treatment C (TMC435350 200 mg once daily+rifampin 600 mg once daily for 7 days). Participants will receive 1 treatment (A, B, or C) during each treatment session. There will be 3 treatment sessions, each treatment session will be separated by 10 days.

Drug: TMC435350; Drug: Rifampin; Drug: TMC435350+rifampin

Treatment Sequence BCA

EXPERIMENTAL

Drug: TMC435350; Drug: Rifampin; Drug: TMC435350+rifampin

Treatment Sequence CAB

EXPERIMENTAL

Drug: TMC435350; Drug: Rifampin; Drug: TMC435350+rifampin

Treatment sequence CBA

EXPERIMENTAL

Drug: TMC435350; Drug: Rifampin; Drug: TMC435350+rifampin

Treatment Sequence BAC

EXPERIMENTAL

Drug: TMC435350; Drug: Rifampin; Drug: TMC435350+rifampin

Treatment Sequence ACB

EXPERIMENTAL

Drug: TMC435350; Drug: Rifampin; Drug: TMC435350+rifampin

Interventions

TMC435350 DRUG

200 mg taken by mouth once daily for 7 days

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment sequence CBA

Rifampin DRUG

600 mg taken by mouth once daily for 7 days

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment sequence CBA

TMC435350+rifampin DRUG

The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.

Treatment Sequence ABC; Treatment Sequence ACB; Treatment Sequence BAC; Treatment Sequence BCA; Treatment Sequence CAB; Treatment sequence CBA

Eligibility Criteria

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

You may qualify if:

• Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs, and the results of blood biochemistry, and hematology tests and a urinalysis carried out at screening.

You may not qualify if:

• Past history of heart arrhythmias (extrasystole, tachycardia at rest) or having baseline prolongation of QTc interval \> 450 ms
• history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT syndrome)
• Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post tubal ligation (without reversal operation)
• 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 (confirmed by hepatitis A antibody, hepatitis B surface antigen, or hepatitis C virus antibody, respectively) or human immunodeficiency virus - type 1 (HIV-1) or HIV-2 infection at screening
• A positive urine drug test at screening
• Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
• Currently significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability
• Any history of significant skin disease.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Conditions

Hepatitis C; Tuberculosis

Interventions

Simeprevir; Rifampin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 18, 2013

Record last verified: 2013-04