A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.

NCT ID: NCT01571570

Last Updated: 2013-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants. In addition, this study is to assess for the acceptability of the taste of both liquid formulations.

Detailed Description

TMC435 is being investigated for the treatment of chronic hepatitis C infection. The current study is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study designed to assess the relative bioavailability and food effect of 2 liquid formulations of TMC435, currently being developed for potential pediatric use, compared to the Phase III 150 mg capsule. Also new capsule concept formulations will be investigated in comparison with the Phase III 150 mg capsule. The study will be performed in healthy adult participants and is divided over 3 panels. Participants will be randomized within a panel. Each participant will receive 3 different treatments according to a classical 6-sequence, 3-period Williams design. In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral suspension respectively with other strength will be compared with the capsule used in Phase III. In Panel 3, two different capsule concept formulations will be compared with the capsule used in Phase III. In panels containing the liquids, formulations will be compared under fasted and fed conditions to investigate the food effect. In all treatments, the participants will receive medication on Day 1 of each treatment. There will be a washout period of at least 7 days between subsequent treatments. The main focus of the trial is the pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the blood stream). This evaluation requires multiple blood samples from Day 1 till Day 4 in each treatment. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be evaluated from signing of the Informed Consent Form onwards until the last trial-related visit throughout the study.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Panel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed

Group Type: EXPERIMENTAL

TMC435 150 mg capsule

Intervention Type: DRUG

single oral dose of 150 mg TMC435 150 mg capsule

Treatment B

Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted

Group Type: EXPERIMENTAL

TMC435 150 mg oral suspension (20 mg/mL)

Intervention Type: DRUG

single oral dose of 150 mg TMC435 oral suspension

Treatment C

Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed

Group Type: EXPERIMENTAL

TMC435 150 mg oral suspension (20 mg/mL)

Intervention Type: DRUG

single oral dose of 150 mg TMC435 oral suspension

Treatment D

Panel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed

Group Type: EXPERIMENTAL

TMC435 150 mg capsule

Intervention Type: DRUG

single oral dose of 150 mg TMC435 150 mg capsule

Treatment E

Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted

Group Type: EXPERIMENTAL

TMC435 150 mg oral solution (10 mg/mL)

Intervention Type: DRUG

single oral dose of 150 mg TMC435 oral solution

Treatment F

Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed

Group Type: EXPERIMENTAL

TMC435 150 mg oral solution (10 mg/mL)

Intervention Type: DRUG

single oral dose of 150 mg TMC435 oral solution

Treatment G

Panel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed

Group Type: EXPERIMENTAL

TMC435 150 mg capsule

Intervention Type: DRUG

single oral dose of 150 mg TMC435 150 mg capsule

Treatment H

Panel 3: single oral dose of 150 mg TMC435 capsule concept K, fed

Group Type: EXPERIMENTAL

TMC435 150 mg capsule concept K

Intervention Type: DRUG

single oral dose of 150 mg TMC435 capsule concept K

Treatment I

Panel 3: single oral dose of 150 mg TMC435 capsule concept L, fed

Group Type: EXPERIMENTAL

TMC435 150 mg capsule concept L

Intervention Type: DRUG

single oral dose of 150 mg TMC435 capsule concept L

Interventions

TMC435 150 mg capsule

single oral dose of 150 mg TMC435 150 mg capsule

Intervention Type: DRUG

TMC435 150 mg oral suspension (20 mg/mL)

single oral dose of 150 mg TMC435 oral suspension

Intervention Type: DRUG

TMC435 150 mg oral solution (10 mg/mL)

single oral dose of 150 mg TMC435 oral solution

Intervention Type: DRUG

TMC435 150 mg capsule concept K

single oral dose of 150 mg TMC435 capsule concept K

Intervention Type: DRUG

TMC435 150 mg capsule concept L

single oral dose of 150 mg TMC435 capsule concept L

Intervention Type: DRUG

Other Intervention Names

TMC435; TMC435; TMC435; TMC435; TMC435

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead electrocardiogram and vital signs, performed at screening, have a body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to screening.
• Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.

Exclusion Criteria

• All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
• Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen.
• Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant or prevent the subject from meeting or performing study requirements.
• History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
• Participation in an investigational drug trial with TMC435.
• Infected with HIV or Hepatitic A, B or C.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen R&D Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen R&D Ireland Clinical Trial

Role: STUDY_DIRECTOR

Janssen R&D Ireland

Locations

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

TMC435HPC1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR100787

Identifier Type: -

Identifier Source: org_study_id