Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

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Abbott

Status and phase

Completed
Phase 1

Conditions

HCV Infection

Treatments

Drug: Placebo for ritonavir
Drug: Placebo for ABT-450
Drug: ABT-450
Drug: ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00931281
M10-861

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Full description

This is a multiple ascending dose, non-fasting, open label, randomized study.

Enrollment

38 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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 within the 6-month period prior to study drug administration
  • donation or loss of 550mL 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

Trial design

38 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
ABT-450/ritonavir
Treatment:
Drug: ritonavir
Drug: ABT-450
2
Placebo Comparator group
Description:
Placebo for ABT-450/placebo for ritonavir
Treatment:
Drug: Placebo for ABT-450
Drug: Placebo for ritonavir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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