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

HCV Infection Clinical Trial

Official title:

A Blinded, Randomized, Nonfasting, Placebo-Controlled Study in Healthy Adults to Evaluate Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Ascending Doses of ABT-450 With Ritonavir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931281
• Other study ID #: M10-861
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2009
• Last updated: October 11, 2010
• Start date: June 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-450
capsules, QD or BID, 14 days, ascending doses
• ritonavir
capsules, QD or BID, 14 days, ascending doses
• Placebo for ABT-450
capsule, QD or BID, 14 days
• Placebo for ritonavir
capsule, QD or BID, 14 days

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 18161	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (blood draws, pre- and post-dose)		17 days	No
Primary	Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)		30 days	Yes