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A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus

NCT ID: NCT01479881

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the single-dose pharmacokinetics of the immunosuppressants cyclosporine and tacrolimus in healthy participants. Cyclosporine and tacrolimus are immunosuppressants used to prevent transplant rejection and may therefore potentially be coadministered with TMC435 in patients infected with hepatitis C virus that undergo liver transplantation. We will also explore the short-term safety and tolerability following coadministration of TMC435 at steady-state and (1) cyclosporine or (2) tacrolimus after single dosing in healthy participants. 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. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Detailed Description

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TMC435 is a protease inhibitor (PI) and is being investigated for treatment of chronic hepatitis C virus (HCV) infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). This is a Phase I, open-label (both participant and investigator know the name of the medication given at a certain moment) trial in 28 healthy participants to investigate the effect of TMC435 at steady-state on the single dose pharmacokinetics of the immunosuppressants cyclosporine and tacrolimus. The trial population will consist of a total of 28 healthy participants, equally divided over 2 panels. In Panel 1, each participant will receive 2 treatments: a single 100-mg dose of cyclosporine on Day 1 and TMC435 150 mg once daily for 10 days on Days 1 to 10, coadministered with a single 100-mg dose of cyclosporine on Day 7. In Panel 2, each participant will receive 2 treatments: a single 2-mg dose of tacrolimus on Day 1 and TMC435 150 mg each day for 12 days on Days 1 to 12, coadministered with a single 2-mg dose of tacrolimus on Day 7. Safety and tolerability will be assessed during the study period and during follow up. Blood and urine safety samples, electrocardiogram (ECG) and vital signs (blood pressure and heart rate) will be taken at screening, Day1, Day 2 (only panel 1), Day 7(only panel 2), Day 8 (only panel 2) and at the follow-up visit about 5 to 7 days after last TMC435 intake.

Conditions

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Hepatitis C Virus

Keywords

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Hepatitis C Virus TMC435 TMC435-TiDP16-C120 TMC435-C120 HCV Hepatitis C Hep C Healthy participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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001

a single 100-mg dose of cyclosporine, and after a wash out period of at least 10 days, TMC435 150 mg once daily (q.d.) for 10 days on Days 1 to 10, coadministered with a single 100-mg dose of cyclosporine on Day 7.

Group Type EXPERIMENTAL

cyclosporine

Intervention Type DRUG

A single 100-mg dose of cyclosporine (on Day 1 of treatment A and on Day 7 of treatment B).

TMC435

Intervention Type DRUG

TMC435, 150 mg daily for 10 days (Day 1 - 10 in treatment B).

002

TMC435 150 mg once daily (q.d.) for 10 days on Days 1 to 10, coadministered with a single 100-mg dose of cyclosporine on Day 7 and after a wash out period of at least 10 days, a single 100-mg dose of cyclosporine.

Group Type EXPERIMENTAL

cyclosporine

Intervention Type DRUG

A single 100-mg dose of cyclosporine (on Day 1 of treatment A and on Day 7 of treatment B).

TMC435

Intervention Type DRUG

TMC435, 150 mg daily for 10 days (Day 1 - 10 in treatment B).

003

a single 2-mg dose of tacrolimus on Day 1. After a wash out period of at least 10 days, participants will receive TMC435 150 mg q.d. for 12 days on Days 1 to 12, coadministered with a single 2-mg dose of tacrolimus on Day 7.

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

a single 2-mg dose of tacrolimus (on Day 1 in treatment C and on Day 7 in treatment D).

TMC435

Intervention Type DRUG

TMC435, 150 mg daily for 12 days (Days 1 to 12 in treatment D).

004

TMC435 150 mg q.d. for 12 days on Days 1 to 12, coadministered with a single 2-mg dose of tacrolimus on Day 7. After a wash out period of at least 10 days, participants receive a single 2-mg dose of tacrolimus.

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

a single 2-mg dose of tacrolimus (on Day 1 in treatment C and on Day 7 in treatment D).

TMC435

Intervention Type DRUG

TMC435, 150 mg daily for 12 days (Days 1 to 12 in treatment D).

Interventions

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tacrolimus

a single 2-mg dose of tacrolimus (on Day 1 in treatment C and on Day 7 in treatment D).

Intervention Type DRUG

TMC435

TMC435, 150 mg daily for 12 days (Days 1 to 12 in treatment D).

Intervention Type DRUG

cyclosporine

A single 100-mg dose of cyclosporine (on Day 1 of treatment A and on Day 7 of treatment B).

Intervention Type DRUG

TMC435

TMC435, 150 mg daily for 10 days (Day 1 - 10 in treatment B).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women must be postmenopausal for at least 2 years, OR be surgically sterile, OR be not heterosexually active for the duration of the study or have a vasectomized partner OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control before entry, and agree to continue to use the same method of contraception throughout the study and for at least 30 days after the last administration of study drug(s).

Exclusion Criteria

* A positive Human Immunodeficiency Virus (HIV)-1 or HIV-2 test at screening;
* A positive Hepatitis A, B and C test at screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tibotec Pharmaceuticals, Ireland

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tibotec Pharmaceuticals, Ireland Clinical Trial

Role: STUDY_DIRECTOR

Tibotec Pharmaceuticals, Ireland

Locations

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Merksem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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TMC435-TIDP16-C120

Identifier Type: OTHER

Identifier Source: secondary_id

2011-003021-96

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100686

Identifier Type: -

Identifier Source: org_study_id