Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

HCV Infection Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850044
• Other study ID #: M10-749
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2009
• Last updated: November 16, 2017
• Start date: February 2009

Study information

• Verified date: September 2010
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• overall healthy subjects

• non-childbearing potential females included

Exclusion Criteria:

• history of significant sensitivity to any drug

• positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab

• history of gastrointestinal issues or procedures

• history of seizures, diabetes or cancer (except basal cell carcinoma)

• clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder

• use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration

• donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration

• abnormal screening laboratory results that are considered clinically significant by the investigator

• current enrollment in another clinical study

• previous enrollment in this study

• recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol

• pregnant or breastfeeding female

• requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-450
capsules,QD, one dose, see Arm Descriptions for more information
• ritonavir
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
• placebo for ABT-450
capsules, QD, one dose
• Placebo for ritonavir
capsules, QD, one dose

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 15981	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

References & Publications (1)

Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM. Pharmacokinetics and tolerability of paritaprevir, a direct acting antiviral agent for hepatitis C virus treatment, with and without ritonavir in healthy volunteers. Br J Clin Pharmacol. 2016 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (blood draws, pre- and post-dose)		4 days
Primary	Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)		10 days