Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
This is a multiple ascending dose, non-fasting, open label, randomized study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 1 ABT-450/ritonavir |
Drug: ABT-450
capsules, QD or BID, 14 days, ascending doses
Drug: ritonavir
capsules, QD or BID, 14 days, ascending doses
Other Names:
|
Placebo Comparator: 2 Placebo for ABT-450/placebo for ritonavir |
Drug: Placebo for ABT-450
capsule, QD or BID, 14 days
Other Names:
Drug: Placebo for ritonavir
capsule, QD or BID, 14 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (blood draws, pre- and post-dose) [17 days]
- Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs) [30 days]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Site Reference ID/Investigator# 18161 | Waukegan | Illinois | United States | 60085 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Isabelle A Gaultier, M.S., IBMH, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M10-861