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

NCT00752648 | Completed Phase 1

• 1 other identifier: CR015415
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatitis C; HCV

Keywords

TMC435350-TiDP16-C106; TMC435350-C106; Bioavailability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

TMC435350 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals Limited Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 28, 2010

Record last verified: 2010-04