Back to resultsStudy in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Primary Purpose
HCV Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-450
ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for HCV Infection focused on measuring Food effect
Eligibility 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 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
Sites / Locations
- Site Reference ID/Investigator# 19421
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Non-fasting
Fasting
Outcomes
Primary Outcome Measures
Pharmacokinetics (blood draws, pre- and post-dose)
Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00909311
Brief Title
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Official Title
Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection
Keywords
Food effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Non-fasting
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fasting
Intervention Type
Drug
Intervention Name(s)
ABT-450
Intervention Description
capsules, QD, 1 dose in each cross-over period
Intervention Type
Drug
Intervention Name(s)
ritonavir
Other Intervention Name(s)
ABT-538, Norvir
Intervention Description
capsule, QD, 1 dose in each cross-over period
Primary Outcome Measure Information:
Title
Pharmacokinetics (blood draws, pre- and post-dose)
Time Frame
17 days
Title
Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle A Gaultier, M.S., IBMH
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 19421
City
Waukegan
State/Province
Illinois
ZIP/Postal Code
60085
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
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