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

NCT01571570 | Completed Phase 1

• 2 other identifiers: CR100787TMC435HPC1002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; Food effect; Capsule; Formulations; Liquid formulation; Concept K; Concept L; Oral suspension; Oral solution; TMC435HPC1002; TMC435; HPC

Outcome Measures

Primary Outcomes (3)

• Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)

  Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension \[150 mg ie, 20 mg/mL\] and oral solution \[150 mg ie, 10 mg/mL\]) versus capsule formulation (150 mg) of TMC435, after a high-fat breakfast (fed state)

  4 days

• Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state

  Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension \[150 mg ie, 20 mg/mL\] and oral solution \[150 mg ie, 10 mg/mL\]) of TMC435 in fed state (high-fat breakfast) versus fasted state

  4 days

• Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)

  Comparing the rate and extent of absorption (bioavailability) of 2 different capsule formulations (concept K capsule \[150 mg\] and concept L capsule \[150 mg\]) versus capsule formulation (150 mg) of TMC435 after a high-fat breakfast (fed state)

  4 days

Secondary Outcomes (2)

• Number of participants with adverse events

  18 days

• Acceptability of taste assessed by taste questionnaires

  Day 1 of Treatment B and E

Study Arms (9)

Treatment A

EXPERIMENTAL

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

Drug: TMC435 150 mg capsule

Treatment B

EXPERIMENTAL

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

Drug: TMC435 150 mg oral suspension (20 mg/mL)

Treatment C

EXPERIMENTAL

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

Drug: TMC435 150 mg oral suspension (20 mg/mL)

Treatment D

EXPERIMENTAL

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

Drug: TMC435 150 mg capsule

Treatment E

EXPERIMENTAL

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

Drug: TMC435 150 mg oral solution (10 mg/mL)

Treatment F

EXPERIMENTAL

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

Drug: TMC435 150 mg oral solution (10 mg/mL)

Treatment G

EXPERIMENTAL

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

Drug: TMC435 150 mg capsule

Treatment H

EXPERIMENTAL

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

Drug: TMC435 150 mg capsule concept K

Treatment I

EXPERIMENTAL

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

Drug: TMC435 150 mg capsule concept L

Interventions

TMC435 150 mg capsule DRUG

single oral dose of 150 mg TMC435 150 mg capsule

Also known as: TMC435

Treatment A; Treatment D; Treatment G

TMC435 150 mg oral suspension (20 mg/mL) DRUG

single oral dose of 150 mg TMC435 oral suspension

Also known as: TMC435

Treatment B; Treatment C

TMC435 150 mg oral solution (10 mg/mL) DRUG

single oral dose of 150 mg TMC435 oral solution

Also known as: TMC435

Treatment E; Treatment F

TMC435 150 mg capsule concept K DRUG

single oral dose of 150 mg TMC435 capsule concept K

Also known as: TMC435

Treatment H

TMC435 150 mg capsule concept L DRUG

single oral dose of 150 mg TMC435 capsule concept L

Also known as: TMC435

Treatment I

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (1)

Unknown Facility

Harrow, United Kingdom

Location

MeSH Terms

Interventions

Simeprevir; Suspensions; Solutions

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  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 23, 2012
• First Posted: April 5, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

GB (1)