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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

August 12, 2010
January 20, 2012
August 2010
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01181427 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
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 of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HCV Infection
  • Drug: ABT-267
    See arm description
    Other Name: ABT-267
  • Drug: Placebo
    See arms description
    Other Name: Placebo
  • Procedure: Blood Sample Collection
    See arm description
  • Drug: Cytochrome P450 inhibitor
    See arm description
    Other Name: Cytochrome P450 inhibitor
  • Placebo Comparator: Single Ascending Dose (SAD)
    Healthy volunteers, receiving single ascending doses of ABT-267 or placebo.
    Interventions:
    • Drug: ABT-267
    • Drug: 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.
    Interventions:
    • Drug: ABT-267
    • Drug: Placebo
    • Drug: Cytochrome P450 inhibitor
  • Active Comparator: Food Effect (FE)
    Healthy volunteers, receiving ABT-267, multi-dose, food effect.
    Intervention: Drug: 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.
    Interventions:
    • Drug: ABT-267
    • Drug: 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
    Intervention: Procedure: Blood Sample Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
January 2012
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01181427
M12-116
No
Abbott
Abbott
Not Provided
Study Director: Andrew Campbell, MD Abbott
Abbott
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP