TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT01308606
First received: March 3, 2011
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done in healthy volunteers.


Condition Intervention Phase
Hepatitis C
Drug: TMC435 HPMC capsule
Drug: TMC435 HPMC or gelatin capsule
Drug: TMC435 gelatin capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations

Resource links provided by NLM:


Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule [ Time Frame: Over 72 hours for every treatment session ] [ Designated as safety issue: No ]
  • Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state [ Time Frame: Over 72 hours for every treatment session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events and the severity of adverse events [ Time Frame: During maximum 7 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of abnormal values for laboratory parameters [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  • Observed values and changes from baseline of cardiovascular variables [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  • Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  • Physical examination findings and changes from baseline. [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: March 2011
Study Completion Date: June 2011
Arms Assigned Interventions
Experimental: 001
TMC435 gelatin capsule Single intake of one 150-mg capsule without food
Drug: TMC435 gelatin capsule
Single intake of one 150-mg capsule without food
Experimental: 002
TMC435 HPMC capsule Single intake of one 150-mg capsule without food
Drug: TMC435 HPMC capsule
Single intake of one 150-mg capsule without food
Experimental: 003
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food
Drug: TMC435 HPMC or gelatin capsule
Single intake of one 150-mg capsule without food
Experimental: 004
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast
Drug: TMC435 HPMC or gelatin capsule
Single intake of one 150-mg capsule after standardized breakfast
Experimental: 005
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast
Drug: TMC435 HPMC or gelatin capsule
Single intake of one 150-mg capsule after high-fat breakfast

Detailed Description:

This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be up to 6 or 7 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. Treatment A is a single dose of TMC345 as one formulation (1 capsule). Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule). Both treatments will be taken without food. In between the 2 sessions, there will be at least 7 days. In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance. All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part. In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast. In between the sessions, there will be at least 7 days. For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after. The 3 following mornings, participants will come back to the study center. Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug). In every treatment session, a single oral 150 mg TMC435 capsule will be given. One formulation will be a gelatin capsule. The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smokers for at least 3 months prior to screening
  • Have a body mass index of 18.0 to 30.0 kg per square meter
  • Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening

Exclusion Criteria:

  • Use of disallowed therapies, including over-the-counter products and dietary supplements
  • Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
  • Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
  • History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308606

Sponsors and Collaborators
Tibotec Pharmaceuticals, Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
  More Information

No publications provided

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT01308606     History of Changes
Other Study ID Numbers: CR015940, TMC435-TiDP16-C116
Study First Received: March 3, 2011
Last Updated: October 10, 2012
Health Authority: Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC435-TiDP16-C116
TMC435-C116
TMC435
HCV
Hepatitis C
Hep C
healthy volunteers

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 20, 2014