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Completed

NCT Number: NCT00850044

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

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.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 15981

Waukegan, Illinois, 60085, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-450

Drug

capsules,QD, one dose, see Arm Descriptions for more information

Ritonavir

Drug

capsules, QD, one dose, escalating doses, see Arm Descriptions for more information

Other names: ABT-538, Norvir

Placebo for ABT-450

Drug

capsules, QD, one dose

Other names: placebo

Placebo for ritonavir

Drug

capsules, QD, one dose

Other names: placebo

Primary outcomes

  1. Pharmacokinetics (blood draws, pre- and post-dose)

    Time frame: 4 days

  2. Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
Feb 24, 2009
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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