TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and Rosuvastatin

NCT01288742 | Completed Phase 1

• 2 other identifiers: CR017770TMC435-TiDP16-C108
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the single-dose pharmacokinetics of digoxin or rosuvastatin , and the effect of a single dose of digoxin or rosuvastatin on the steady-state pharmacokinetics of TMC435. 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-C108; TMC435-C108; TMC435; HPC; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (4)

• Change in absorption of TMC435 following co-administration with Digoxin (Panel 1).

  Measured on Days 1, 5-11 (Trt B). Reference for TMC435 is from historical data.

• Change in absorption of Digoxin following co-administration with TMC435 (Panel 1).

  Measured on Day 7-11 (Trt B). Reference for Digoxin is on Day 1-5 of Trt A.

• Change in absorption of TMC435 following co-administration with rosuvastatin (Panel 2).

  Measured on Day 1, 5-11 (Trt D). Reference for TMC435 are historical data.

• Change in absorption of rosuvastatin following co-administration with TMC435 (Panel 2).

  Measured on Day 7-11 (Trt D). Reference for rosuvastatin is on Days 1-5 of Trt C.

Secondary Outcomes (2)

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

  51 to 56 days (until and including last safety follow-up visit) for Panel 1

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

  51 to 56 days (until and including last safety follow-up visit) for Panel 2

Study Arms (5)

001

EXPERIMENTAL

TMC435 One 150-mg capsule once daily for 7 days (Trts B and D).

Drug: TMC435

002

EXPERIMENTAL

Digoxin One 0.25-mg tablet for 1 day (Trt A)

Drug: Digoxin

003

EXPERIMENTAL

Digoxin One 0.25-mg tablet together with 1 capsule of TMC435 (150 mg) on Day 7 of Trt B.

Drug: Digoxin

004

EXPERIMENTAL

Rosuvastatin One 10-mg tablet for 1 day (Trt C).

Drug: Rosuvastatin

005

EXPERIMENTAL

Rosuvastatin One 10-mg tablet together with 1 capsule of TMC435 (150 mg) on Day 7 of Trt D.

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

One 10-mg tablet for 1 day (Trt C).

004

TMC435 DRUG

One 150-mg capsule once daily for 7 days (Trts B and D).

001

Digoxin DRUG

One 0.25-mg tablet together with 1 capsule of TMC435 (150 mg) on Day 7 of Trt B.

003

Eligibility Criteria

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

You may qualify if:

• Non-smoker or not having chewed tobacco for at least 6 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 participated in a multiple-dose trial with TMC435
• Having previously participated in more than 3 single-dose trials with TMC435
• History of rhabdomyolysis or other muscle abnormalities upon statin intake (Panel 2).

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

Rosuvastatin Calcium; Simeprevir; Digoxin

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)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

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: January 20, 2011
• First Posted: February 2, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 30, 2012

Record last verified: 2012-11