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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01181427 |
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Date of registration:
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12/08/2010 |
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Primary sponsor: |
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Public title:
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Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
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Scientific title:
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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 |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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137 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01181427 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew Campbell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HCV Infection
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Intervention(s)
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Drug: ABT-267
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Drug: Cytochrome P450 inhibitor
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Drug: Placebo
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Procedure: Blood Sample Collection
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Primary Outcome(s)
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Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
[Time Frame: Up to 15 days or less]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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