TMC435350-TiDP16-C101 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing

NCT00938899 | Completed Phase 1

• 1 other identifier: CR012610
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV genotype1 infected patients.

Conditions

Hepatitis C

Keywords

TMC435350-TiDP16-C101; TMC435350-C101; TMC435350; HCV

Outcome Measures

Primary Outcomes (1)

• Determine the safety, tolerability and pharmacokinetics of TMC435350 after single oral doses from 50 mg up to 1200 mg and after 5 days of dosing from 50 mg up to 400 mg or up to Multiple dosing.

  Pharmacokinetics and safety at time of drug intake until 72hour after the drug intake

Interventions

TMC435350; Placebo DRUG

Eligibility Criteria

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

You may qualify if:

• \- Healthy participants must be non-smokers, normal weight, normal ECG, healthy on the basis of a medical evaluation, physical examination, medical history, ECG, vital signs, and laboratory results
• HCV patients must be of normal weight, normal ECG, chronic genotype 1 HCV infection, non-responders or relapsers to previous treatment regimens and have a HCV viral load at least 50000 IU/mL plasma at screening.

You may not qualify if:

• Patients with history of cardiac disease, HIV-1 or HIV-2 test
• Women of childbearing potential
• History or evidence of abuse of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, hepatitis A, B or C infection
• Positive urine drug test
• Any active or underlying disease
• History of drug allergy or hypersensitivity
• Participation in an investigational trial within 30 days prior to the first intake of study medication
• Recent donation of blood
• Abnormal laboratory values
• HCV patients with cardiac disease, co-infections with HIV-1, HIV-2 or liver infection other than HCV
• Women of childbearing potential
• Participants not agreeing to use a reliable birth control method until last trial visit
• Drug abuse
• Cardiovascular, hepatic or renal disease, diabetes, epilepsy, skin or psychiatric disease
• Enrolled in another clinical trial for 90 days prior to screening

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Related Publications (1)

• Reesink HW, Fanning GC, Farha KA, Weegink C, Van Vliet A, Van 't Klooster G, Lenz O, Aharchi F, Marien K, Van Remoortere P, de Kock H, Broeckaert F, Meyvisch P, Van Beirendonck E, Simmen K, Verloes R. Rapid HCV-RNA decline with once daily TMC435: a phase I study in healthy volunteers and hepatitis C patients. Gastroenterology. 2010 Mar;138(3):913-21. doi: 10.1053/j.gastro.2009.10.033. Epub 2009 Oct 21.

  PMID: 19852962 DERIVED

Related Links

• Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine safety, tolerability, PK of increasing single and repeating oral doses of TMC435, followed by an open label repeated dosing session in 6 HCV G1 infected patients.

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
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 14, 2009
• Study Start: January 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 19, 2011

Record last verified: 2010-04