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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:
ClinicalTrials.gov Identifier:
NCT00752648
First Posted: September 15, 2008
Last Update Posted: April 28, 2010
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.
Information provided by:
Tibotec Pharmaceuticals, Ireland
  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
Intervention Model: Crossover Assignment
Masking: None (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:


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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00752648


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

ClinicalTrials.gov Identifier: NCT00752648     History of Changes
Other Study ID Numbers: CR015415
First Submitted: September 11, 2008
First Posted: September 15, 2008
Last Update Posted: April 28, 2010
Last Verified: April 2010

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

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Simeprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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