TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435

NCT01381835 | Completed Phase 1 DMC

• 2 other identifiers: CR017953TMC435-TiDP16-C126
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the steady-state pharmacokinetics of TMC435 in participants with severe renal impairment and to compare these with the TMC435 pharmacokinetics in matched participants with normal renal function. We will also study the short-term safety and tolerability of TMC435, when administered in participants with severe renal impairment and in participants with normal renal function. Steady-state is a term that 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-C126; TMC435-C126; TMC435; HCV; Hepatitis C; Hep C; severe renal impairement

Outcome Measures

Primary Outcomes (1)

• Change in the steady-state plasma pharmacokinetics of TMC435 following administration in participants with severe renal impairement, as compared to the matching healthy participants.

  Measured on Day 5-10.

Secondary Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to Day 63

Study Arms (1)

001

EXPERIMENTAL

TMC435 150 mg capsule once daily for 7 days

Drug: TMC435

Interventions

TMC435 DRUG

150 mg capsule once daily for 7 days

001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening. Body Mass Index of 18.0 to 35.0 kg/m2
• Healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram.

You may not qualify if:

• Infection with hepatitis A, B or C virus
• Infection with the human immunodeficiency virus (HIV)
• History of or any current medical condition which could impact the safety of the participant in the study
• Having previously been dosed with TMC435 in a multiple-dose trial with TMC435
• Having previously been dosed with TMC435 in more than 3 single-dose trials with TMC435.
• Participants with severe renal impairment must also not have any of the following characteristics: 1. History of renal transplant or renal carcinoma. Participants with a history of renal carcinoma who have been cancer free for at least 5 years may be included. 2. Uncontrolled hypertension. 3. Hepatorenal syndrome. 4. Imminent renal replacement therapy (i.e., during the trial period).
• Matched healthy subjects must also not have the following characteristics: History of congenital or hereditary kidney disease (including polycystic kidney disease), nephrectomy, renal transplant or nephrolitiasis.

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (1)

Unknown Facility

Prague, Czechia

Location

Related Links

• A Phase I, open-label trial to investigate the effect of severe renal impairment on the pharmacokinetics and safety of TMC435

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 Clinical Trial

  Tibotec Pharmaceutical Limited

  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 23, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2011
• Study Completion: January 1, 2012
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

CZ (1)