Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

• ClinicalTrials.gov Identifier: NCT01181427
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: January 24, 2012
• Sponsor: Abbott
• Information provided by (Responsible Party): Abbott

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
HCV Infection	Drug: ABT-267; Drug: Placebo; Procedure: Blood Sample Collection; Drug: Cytochrome P450 inhibitor	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: August 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Single Ascending Dose (SAD); Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.	Drug: ABT-267; See arm description; Drug: Placebo; See arms description
Placebo Comparator: Multiple Ascending Dose (MAD); Healthy volunteers, receiving multiple ascending doses of ABT-267 or placebo, OR, multiple doses of ABT-267 + single dose of a Cytochrome P450 inhibitor or placebo + single dose of a Cytochrome P450 inhibitor.	Drug: ABT-267; See arm description; Drug: Placebo; See arms description; Drug: Cytochrome P450 inhibitor; See arm description
Active Comparator: Food Effect (FE); Healthy volunteers, receiving ABT-267, multi-dose, food effect.	Drug: ABT-267; See arm description
Placebo Comparator: Antiviral Activity; HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.	Drug: ABT-267; See arm description; Drug: Placebo; See arms description
No Intervention: Resistance Monitoring; HCV genotype 1-infected treatment naïve subjects, receiving at least one dose of ABT-267 or placebo in the "Antiviral Activity" arm, follow-up to monitor resistance developed to ABT-267, no treatment and only blood samples will be collected	Procedure: Blood Sample Collection; See arm description

Outcome Measures

Primary Outcome Measures :

1. Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. [ Time Frame: Up to 15 days or less ]
2. 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). [ Time Frame: Update to 20 days or less ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Site Reference ID/Investigator# 42708

Orlando, Florida, United States, 32809

United States, Illinois

Site Reference ID/Investigator# 43322

Waukegan, Illinois, United States, 60085

United States, Texas

Site Reference ID/Investigator# 42707

San Antonio, Texas, United States, 78215

Sponsors and Collaborators

Abbott

Investigators

• Study Director: Andrew Campbell, MD; Abbott

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01181427
• Other Study ID Numbers: M12-116
• First Posted: August 13, 2010
• Last Update Posted: January 24, 2012
• Last Verified: January 2012

Additional relevant MeSH terms:

Hepatitis C; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action