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

NCT00909311 | Completed Phase 1

• 1 other identifier: M10-923
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Conditions

HCV Infection

Keywords

Food effect

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (blood draws, pre- and post-dose)

  17 days

• Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)

  30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Non-fasting

Drug: ABT-450; Drug: ritonavir

2

ACTIVE COMPARATOR

Fasting

Drug: ABT-450; Drug: ritonavir

Interventions

ABT-450 DRUG

capsules, QD, 1 dose in each cross-over period

1; 2

ritonavir DRUG

capsule, QD, 1 dose in each cross-over period

Also known as: ABT-538, Norvir

1; 2

Eligibility Criteria

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

You may qualify if:

• overall healthy subjects;
• non-childbearing potential females included

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 19421

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

paritaprevir; Ritonavir

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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Isabelle A Gaultier, M.S., IBMH

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: October 13, 2010

Record last verified: 2009-09

Locations

US (1)