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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01181427
First received: August 12, 2010
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
HCV Infection
Drug: ABT-267
Drug: Placebo
Procedure: Blood Sample Collection
Drug: Cytochrome P450 inhibitor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline. [ Time Frame: Up to 15 days or less ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 137
Study Start Date: August 2010
Study Completion Date: January 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Single Ascending Dose (SAD)
Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.
Drug: ABT-267
See arm description
Other Name: ABT-267
Drug: Placebo
See arms description
Other Name: Placebo
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
Other Name: ABT-267
Drug: Placebo
See arms description
Other Name: Placebo
Drug: Cytochrome P450 inhibitor
See arm description
Other Name: Cytochrome P450 inhibitor
Active Comparator: Food Effect (FE)
Healthy volunteers, receiving ABT-267, multi-dose, food effect.
Drug: ABT-267
See arm description
Other Name: ABT-267
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
Other Name: ABT-267
Drug: Placebo
See arms description
Other Name: Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181427

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01181427     History of Changes
Other Study ID Numbers: M12-116
Study First Received: August 12, 2010
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014