A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers

NCT01891851 | Completed Phase 1

• 2 other identifiers: CR014773TMC435350-TiDP16-C104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.

Conditions

Healthy

Keywords

Healthy; Hepatitis C; TMC435350; Ritonavir; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Plasma concentration of TMC435350

  In Session 1, the plasma concentration of TMC435350 is measured in the absence of ritonavir.

  Days 1 and 7 of Session 1

• Plasma concentration of TMC435350

  In Session 2, the plasma concentration of TMC435350 is measured in the presence of ritonavir.

  Days 6 and 16 of Session 2

Secondary Outcomes (1)

• Number of patients reporting adverse events (AEs) as a measure of safety and tolerability

  Up to approximately 86 days

Study Arms (1)

TMC435350 / Ritonavir

EXPERIMENTAL

TMC435350 2 capsules of 100-mg twice daily / Ritonavir one 100-mg capsule twice daily

Drug: TMC435350 200 mg; Drug: Ritonavir 100 mg

Interventions

TMC435350 200 mg DRUG

Each patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2

TMC435350 / Ritonavir

Ritonavir 100 mg DRUG

Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2

TMC435350 / Ritonavir

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• 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 Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
• Informed Consent Form signed voluntarily, prior to the first trial related activity
• normal 12-lead electrocardiogram (ECG) at screening
• healthy on the basis of a medical evaluation and results fo the laboratory tests at screening.

You may not qualify if:

• past history of heart arrhythmias,
• female, except if postmenopausal for more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
• history or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
• hepatitis A, B and C infections or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infections at study screening
• donation of blood or plasma in the 60 days preceding the first intake of trial medication

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (1)

Unknown Facility

Aalst, Belgium

Location

Related Links

• Phase I, open-label trial in healthy subjects to evaluate the drug-drug interaction between ritonavir at steady-state and TMC435350, a viral protease inhibitor against hepatitis C virus, after the first and the last dose of a multiple dosing regimen

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir; Ritonavir

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; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Tibotec Pharmaceuticals Limited, Ireland Clinical Trial

  Tibotec Pharmaceuticals, Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

BE (1)