TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

NCT01323257 | Completed Phase 1

• 2 other identifiers: CR018010TMC435-TiDP16-C115
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of steady-state concentrations of erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r (Panel 2). Steady state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

Conditions

Hepatitis C Virus

Keywords

TMC435-TiDP16-C115; TMC435-C115; TMC435; HCV; Hepatitis C; Hep C; healthy volunteers

Outcome Measures

Primary Outcomes (2)

• Change in the steady-state plasma pharmacokinetics of TMC435 following co-administration with erythromycin (Panel 1).

  Measured on Day 1 and Day 5-10 (Trt C). Reference for TMC435 is on Day 1 and Day 5-10 of Trt A.

• Change in the steady-state plasma pharmacokinetics of TMC435 following co-administration with DRV/r (Panel 2).

  Measured on Day 1 and Day 5-10 (Trt F). Reference for TMC435 is on Day 1 and Day 5-10 of Trt D.

Secondary Outcomes (4)

• Change in the steady-state plasma pharmacokinetics of erythromycin following co-administration with TMC435 (Panel 1).

  Measured on Day 1 and Day 5-7 (Trt C). Reference for erythromycin is on Day 1 and Day 5-7 of Trt B.

• Change in the steady-state plasma pharmacokinetics of DRV/r following co-administration with TMC435 (Panel 2).

  Measured on Day 1 and Day 5-8 (Trt F). Reference for DRV/r is on Day 1 and Day 5-8 of Trt E.

• Number of participants with adverse events as a measure of safety and tolerability - TMC435 and erythromycin

  Up to Day 67

• Number of participants with adverse events as a measure of safety and tolerability - TMC435 and DRV/r

  Up to Day 61

Study Arms (6)

001

EXPERIMENTAL

TMC435 150 mg capsule once daily for 7 days (Trt A C D)

Drug: TMC435

002

EXPERIMENTAL

erythromycin 500 mg tablets three times a day for 6 days + 1 morning dose for 7th day (Trt B)

Drug: erythromycin

003

EXPERIMENTAL

erythromycin 500 mg tablets three times a day for 7 days (Trt C)

Drug: erythromycin

004

EXPERIMENTAL

TMC435 50 mg capsule once daily for 7 days (Trt F)

Drug: TMC435

005

EXPERIMENTAL

Darunavir 2 x 400 mg tablet once daily for 7 days (Trt E F)

Drug: Darunavir

006

EXPERIMENTAL

Ritonavir 100 mg tablet once daily for 7 days (Trt E F)

Drug: Ritonavir

Interventions

erythromycin DRUG

500 mg tablets three times a day for 6 days + 1 morning dose for 7th day (Trt B)

002

Ritonavir DRUG

100 mg tablet once daily for 7 days (Trt E, F)

006

TMC435 DRUG

150 mg capsule once daily for 7 days (Trt A, C, D)

001

Darunavir DRUG

2 x 400 mg tablet once daily for 7 days (Trt E, F)

005

Eligibility Criteria

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

You may qualify if:

• Non-smoker for at least 3 months
• Body Mass Index of 18.0 to 30.0 kg/m2
• Healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram

You may not qualify if:

• Infection with hepatitis A, B or C virus
• Infection with the human immunodeficiency virus (HIV)
• History of or any current medical condition which could impact the safety of the participant in the study
• Having previously been dosed with TMC435 in a multiple-dose trial with TMC435
• Having previously been dosed with TMC435 in more than 3 single-dose trials with TMC435

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Erythromycin; Ritonavir; Simeprevir; Darunavir

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Sulfones; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Carbamates; Acids, Acyclic; Carboxylic Acids; Furans

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 25, 2011
• Study Start: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

BE (1)