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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014