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TMC435350-TiDP16-C106: A Phase I Trial to Compare the Bioavailability and Plasma Pharmacokinetics After a Single Oral Dose of TMC435350 of 2 Different Solid Formulations Relative to a Powder Blend Capsule

This study has been completed.
Sponsor:
Information provided by:
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT00752648
First received: September 11, 2008
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  Purpose

The objectives are: to compare the oral bioavailability and plasma pharmacokinetics of TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder blend in a capsule, after a single oral dose of 200 mg in healthy volunteers; to determine the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg formulated in capsules with 2 different formulations and as a tablet in healthy volunteers


Condition Intervention Phase
Hepatitis C
HCV
 Drug: TMC435350
 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, 3-way Crossover Trial in Healthy Subjects to Compare the Bioavailability of a Single Oral Dose of TMC435350 Formulated as 2 Different Solid Formulations to That of a Single Oral Dose of TMC435350 Formulated as a Powder Blend Capsule.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tibotec Pharmaceuticals, Ireland:

Primary Outcome Measures:
  • To compare the oral bioavailability and plasma pharmacokinetics of TMC435350 for 2 different solid formulations to those of TMC435350 formulated as a powder blend in a capsule, after a single oral dose of 200 mg in healthy volunteers;

Secondary Outcome Measures:
  • To determine the short term safety and tolerability of TMC435350 after a single oral dose of 200 mg formulated as capsules of 2 different formulations and as a tablet in healthy volunteers.

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Detailed Description:

This is a Phase I, open-label, 3-way crossover trial in 12 healthy adult volunteers to compare the oral bioavailability of a single 200 mg intake of TMC435350 salt, formulated as 2 different solid formulations (a tablet and a capsule) to that of a single 200 mg intake of TMC435350 salt, formulated as a powder blend in a capsule. TMC435350 is a protease inhibitor in development for treatment of chronic hepatitis C virus (HCV) infection. During 3 sessions, each volunteer will receive 3 treatments according to a classical 6-sequence, 3-period Williams design.The treatments administered are: Treatment A: single dose of 200 mg TMC435350 salt, formulated as a powder blend filled in a capsule. Treatment B: single dose of 200 mg TMC435350 salt, formulated in a tablet. Treatment C: single dose of 200 mg. MC435350 salt, formulated in beads filled in a capsule. All medication intakes will be oral and under fed conditions. There will be a washout period of at least 7 days between medication intakes in subsequent treatment sessions. Full pharmacokinetic profiles of TMC435350 will be determined up to 72 hours after administration in each session. Safety and tolerability will be monitored continuously throughout the trial. Treatments A, B and C: TMC435350 200mg on Day 1 of each session.Intakes will be oral and in fed conditions.

  Eligibility

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

Inclusion Criteria:

  • Non-smoking for at least 3 months prior to selection
  • Normal weight as defined by 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
  • Informed Consent Form (ICF) signed voluntarily before the first trial-related activity
  • Able to comply with protocol requirements
  • Normal 12-lead electrocardiogram (ECG) (in triplicate) at screening including: Normal sinus rhythm (heart rate [HR] between 40 and 100 bpm), QTc interval = 450 ms, QRS interval < 120 ms, PR interval = 220 ms
  • Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs, and the results of blood biochemistry, and hematology tests and a urinalysis carried out at screening.

Exclusion Criteria:

  • Past history of heart arrhythmias (extrasystolic, tachycardia at rest) or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome (hypokalemia, family history of long QT syndrome)
  • Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post-tubal ligation (without reversal operation)
  • Hepatitis A, B, or C infection, or human immunodeficiency virus - type 1 (HIV-1) or HIV-2 infection at screening
  • A positive urine drug test at screening. Urine will be tested to check the current use of amphetamines, benzodiazepines, cocaine, cannabinoids, and opioids
  • Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease
  • Any history of significant skin disease such as, but not limited to, rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria
  • History of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous trials with experimental drugs
  • Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752648

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

No publications provided

ClinicalTrials.gov Identifier: NCT00752648     History of Changes
Other Study ID Numbers: CR015415
Study First Received: September 11, 2008
Last Updated: April 26, 2010
Health Authority: Ireland: Irish Agriculture and Food Development Authority

Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC435350-TiDP16-C106
TMC435350-C106
Bioavailability
Pharmacokinetics

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 May 19, 2013