- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850044
Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
November 16, 2017 updated by: AbbVie
A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Waukegan, Illinois, United States, 60085
- Site Reference ID/Investigator# 15981
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
ABT-450
|
capsules,QD, one dose, see Arm Descriptions for more information
|
Placebo Comparator: 2
Placebo for ABT-450
|
capsules, QD, one dose
Other Names:
|
Active Comparator: 3
ABT-450/ritonavir
|
capsules,QD, one dose, see Arm Descriptions for more information
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
Other Names:
|
Placebo Comparator: 4
Placebo for ABT-450/placebo for ritonavir
|
capsules, QD, one dose
Other Names:
capsules, QD, one dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (blood draws, pre- and post-dose)
Time Frame: 4 days
|
4 days
|
Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs)
Time Frame: 10 days
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Adebayo A Lawal, MD, Abbott
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
February 20, 2009
First Submitted That Met QC Criteria
February 23, 2009
First Posted (Estimate)
February 24, 2009
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 16, 2017
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
Other Study ID Numbers
- M10-749
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HCV Infection
-
Valme University HospitalBoehringer IngelheimUnknown
-
Sunshine Lake Pharma Co., Ltd.Completed
-
Sunshine Lake Pharma Co., Ltd.Completed
-
Sunshine Lake Pharma Co., Ltd.Recruiting
-
Assiut UniversityUnknown
-
Gilead SciencesCompletedChronic HCV InfectionChina, Hong Kong, Taiwan, Korea, Republic of, Vietnam
-
Fundacion para la Investigacion Biomedica del Hospital...Instituto de Salud Carlos IIICompletedHIV Infection | HCV CoinfectionSpain
-
Gilead SciencesCompletedChronic HCV InfectionChina, Korea, Republic of, Taiwan
-
Gilead SciencesCompleted
-
Naomi LubanNational Heart, Lung, and Blood Institute (NHLBI)CompletedTransfusion-induced HCV and HGV Infection
Clinical Trials on ABT-450
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C Infection
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C Infection
-
AbbVie (prior sponsor, Abbott)Completed
-
AbbVieCompleted
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C Virus | Compensated Cirrhosis
-
AbbVieCompletedChronic Hepatitis C Infection
-
AbbVie (prior sponsor, Abbott)Completed
-
AbbVie (prior sponsor, Abbott)Completed
-
AbbVieCompletedHepatitis C Virus | Hepatitis C Infection
-
AbbVie (prior sponsor, Abbott)CompletedCompensated Cirrhosis | Chronic Hepatitis C Infection