TMC435-TiDP16-C112 - Interaction Trial With Antidepressants

NCT01090700 | Completed Phase 1

• 1 other identifier: CR017044
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Conditions

Hepatitis C Virus

Keywords

TMC435-TiDP16-C112; TMC435-C112; TMC435; HCV; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of stable blood levels of TMC 435 given 150 mg q.d. on the stable blood levels of escitalopram given 10 mg q.d. in healthy participants and vica versa.

  pk profiles of TMC435 will be measured up to 24 hours on Day 7 in Treatment A and C. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7 of Treatment B and C.

Secondary Outcomes (1)

• The short-term safety and tolerability of coadministration of TMC435 and escitalopram in healthy participants (safety and tolerability criteria are the activity of the heart, blood pressure, pulse, physical examination, parameters in urine and blood)

  This will be determined throughout the study; Day-1 through Day 8 in each session, 1 week and 4-5 weeks after last medication intake

Study Arms (3)

001

EXPERIMENTAL

TMC435 TMC435 150 mg daily for 7 days

Drug: TMC435

002

OTHER

Escitalopram Escitalopram 10 mg daily for 7 days

Drug: Escitalopram

003

EXPERIMENTAL

TMC435 + Escitalopram TMC435 150 mg + escitalopram 10 mg daily for 7 days

Drug: TMC435 + Escitalopram

Interventions

TMC435 DRUG

TMC435 150 mg daily for 7 days

001

Escitalopram DRUG

Escitalopram 10 mg daily for 7 days

002

TMC435 + Escitalopram DRUG

TMC435 150 mg + escitalopram 10 mg daily for 7 days

003

Eligibility Criteria

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

You may qualify if:

• Non-smokers for at least 3 months prior to screening
• Healthy on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening
• Healthy on the basis of clinical laboratory tests performed at screening
• Subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
• Participants must have signed the ICF for pharmacogenetic research indicating willingness to participate in the pharmacogenetic component of the study.

You may not qualify if:

• A positive human immunodeficiency virus - type 1 (HIV-1) or HIV-2 test at study screening
• Hepatitis A, B, or C infection (confirmed by hepatitis A antibody immunoglobulin \[IgM\], hepatitis B surface antigen, or hepatitis C virus antibody, respectively) at screening
• History of liver or renal (estimated creatinine clearance below 60 mL/min) insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric and neoplastic or metabolic disturbances
• Known allergies, hypersensitivity, or intolerance to TMC435 or its excipients
• Received an investigational drug (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir; Escitalopram

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; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring

Study Officials

• Tibotec Pharmaceuticals 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 22, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 9, 2013

Record last verified: 2013-04