TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288677
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Brief Summary:
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: TMC649128 Phase 1

Detailed Description:
TMC649128 will be investigated for the treatment of chronic hepatitis C infection. This is a Phase I, first in humans (no clinical studies have been performed to date), double-blind (neither the participant nor investigator knows whether they receive active or placebo), randomized (study medication is assigned by chance), placebo-controlled study to examine the safety, tolerability, and blood and plasma pharmacokinetics of increasing single oral doses of TMC649128. The single dose escalation will consist of 6 sessions (Sessions I to IV) in 6 panels (Panels 1 to 6) of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated. In each session, 6 participants will receive TMC649128 and 3 participants will receive placebo, all with standard meals. Each session will have a staggered approach, ie, the first 4 participants will be dosed, followed by at least a 72-hour safety review and if no acute effects are observed, the remaining 5 participants will be dosed. The main focus of the trial is the determination of safety and tolerability of TMC649128 after single oral doses in fed conditions in healthy volunteers, but also the determination of the pharmacokinetic characteristics (level-profile of TMC649128 over time in the blood stream and urine). This evaluation requires multiple blood samples from Day 1 to Day 4. Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each session, up to 4 weeks after the last administration. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial. The single dose escalation will consist of 6 sessions in 6 panels of 9 healthy adult volunteers each. The dose of TMC649128 will be consecutively escalated.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase I, First In-human, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability, and Blood and Plasma Pharmacokinetics of Increasing Single Oral Doses of TMC649128
Study Start Date : January 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: 001
TMC649128 Escalated doses
Drug: TMC649128
Escalated doses

Primary Outcome Measures :
  1. Number of volunteers with adverse events, if any [ Time Frame: Up to Day 4 ]
  2. Laboratory evaluations of blood and urine samples [ Time Frame: Up to Day 4 ]
  3. Vital signs evaluations [ Time Frame: Up to Day 4 ]
  4. Electrocardiogram evaluations [ Time Frame: Up to Day 4 ]

Secondary Outcome Measures :
  1. Plasma concentration of TMC649128 after a single oral dose of TMC649128 in healthy volunteers in fed conditions [ Time Frame: Measured on Day 1 to Day 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
  • Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker for at least 3 months prior to selection
  • Women must be postmenopausal for at least 2 years and/or be surgically sterile.

Exclusion Criteria:

  • 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
  • A positive urine drug test at screening
  • History of any drug allergy or clinically relevant skin disease
  • Participation in an investigational drug trial or received an investigational vaccine within 30 days prior to intake.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288677

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

Responsible Party: Tibotec Pharmaceuticals, Ireland Identifier: NCT01288677     History of Changes
Other Study ID Numbers: CR017272
TMC649128HPC1001 ( Other Identifier: Tibotec Pharmaceuticals )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Healthy volunteer
Hepatitis C
healthy volunteers
Phase I trial