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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT01288677
First received: January 13, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: TMC649128
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • Number of volunteers with adverse events, if any [ Time Frame: Up to Day 4 ] [ Designated as safety issue: Yes ]
  • Laboratory evaluations of blood and urine samples [ Time Frame: Up to Day 4 ] [ Designated as safety issue: Yes ]
  • Vital signs evaluations [ Time Frame: Up to Day 4 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram evaluations [ Time Frame: Up to Day 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
TMC649128 Escalated doses
Drug: TMC649128
Escalated doses

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288677

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: NCT01288677     History of Changes
Other Study ID Numbers: CR017272, TMC649128HPC1001
Study First Received: January 13, 2011
Last Updated: March 19, 2013
Health Authority: Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
Healthy volunteer
TMC649128HPC1001
TMC649128
HCV
Hepatitis C
healthy volunteers
Phase I trial

ClinicalTrials.gov processed this record on April 21, 2014