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

NCT01181427 | Completed Phase 1

• 1 other identifier: M12-116
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (2)

• Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.

  Up to 15 days or less

• 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).

  Update to 20 days or less

Study Arms (5)

Single Ascending Dose (SAD)

PLACEBO COMPARATOR

Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.

Drug: ABT-267; Drug: Placebo

Multiple Ascending Dose (MAD)

PLACEBO COMPARATOR

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; Drug: Placebo; Drug: Cytochrome P450 inhibitor

Food Effect (FE)

ACTIVE COMPARATOR

Healthy volunteers, receiving ABT-267, multi-dose, food effect.

Drug: ABT-267

Antiviral Activity

PLACEBO COMPARATOR

HCV genotype 1-infected treatment naïve subjects receiving multiple ascending doses of ABT-267 or placebo monotherapy for 3 days.

Drug: ABT-267; Drug: Placebo

Resistance Monitoring

NO INTERVENTION

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

Interventions

ABT-267 DRUG

See arm description

Antiviral Activity; Food Effect (FE); Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Placebo DRUG

See arms description

Antiviral Activity; Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Blood Sample Collection PROCEDURE

See arm description

Resistance Monitoring

Cytochrome P450 inhibitor DRUG

See arm description

Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (3)

Site Reference ID/Investigator# 42708

Orlando, Florida, 32809, United States

Location

Site Reference ID/Investigator# 43322

Waukegan, Illinois, 60085, United States

Location

Site Reference ID/Investigator# 42707

San Antonio, Texas, 78215, United States

Location

Related Publications (1)

• 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.

  PMID: 25451055 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

ombitasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andrew Campbell, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

US (3)