Clinical trial NCT01181427: Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Official title: A Blinded, Randomized, Placebo-Controlled Study in Healthy and HCV Genotype 1-infected Adults, to Evaluate the Safety, Tolerability, Antiviral Activity, Pharmacokinetics (Including the Effect of Food) and Resistance Profile of Single and Multiple Doses of ABT-267
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.


Eligibility criteria: Inclusion Criteria

Main Selection Criteria for Healthy Volunteers:

* Subject has provided written consent.
* Subject is in general good health.
* Females must be post-menopausal for at least 2 years or surgically sterile.
* Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.

Main Selection Criteria for HCV Genotype 1-infected Volunteers:

* Subject has provided written consent.
* Subject has chronic HCV genotype 1 infection at screening.
* Liver biopsy within 3 years with histology.
* Females must be post-menopausal for at least 2 years or surgically sterile.
* Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.
* Subject is in general good health, as perceived by the investigator, other than HCV infection.

Main Selection Criteria for Volunteers in the Resistance Monitoring Portion of the Study:

* Subject has provided written consent, has received at least one dose of ABT-267 or placebo in the study, and is considered suitable by the investigator to participate.

Exclusion Criteria

Main Exclusion Criteria for Healthy Volunteers:

* Positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab.
* 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.
* Abnormal screening laboratory results.
* Significant sensitivity to any drug.
* Requirement for any over the counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.

Main Exclusion Criteria for HCV Genotype 1-infected Volunteers:

* Significant sensitivity to any drug.
* Positive HBsAg, HAV-IgM, and HIV Ab. Use of CYP enzyme inducers or inhibitors within 1 month of dosing.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid disease (except hypothyroidism on stable thyroid replacement therapy), or any uncontrolled medical illness or psychiatric disorder.
* Use of any medications (prescription and over-the counter) within 2 weeks prior to study drug dosing without prior approval by the Abbott Medical Monitor.
* Use of any vitamins or herbal supplements within 2 weeks prior to study drug dosing.
* Prior treatment with any investigational or commercially available anti-HCV agents.
* Abnormal screening laboratory results.

Primary outcomes:
measure: Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
timeFrame: Up to 15 days or less
measure: Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, vital signs, ECGs, continuous cardiac monitoring, and clinical lab results (including chemistry, hematology and urine).
timeFrame: Update to 20 days or less
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 42708
state: Florida
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 43322
state: Illinois
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 42707
state: Texas
Study officials:
affiliation: Abbott
name: Andrew Campbell, MD
role: STUDY_DIRECTOR
References:
citation: Krishnan P, Beyer J, Mistry N, Koev G, Reisch T, DeGoey D, Kati W, Campbell A, Williams L, Xie W, Setze C, Molla A, Collins C, Pilot-Matias T. In vitro and in vivo antiviral activity and resistance profile of ombitasvir, an inhibitor of hepatitis C virus NS5A. Antimicrob Agents Chemother. 2015 Feb;59(2):979-87. doi: 10.1128/AAC.04226-14. Epub 2014 Dec 1.