A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

HCV Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890318
• Other study ID #: M10-705
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2009
• Last updated: October 19, 2010
• Start date: April 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Description:

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Main Selection Criteria for Healthy Volunteers:

• Subject has provided written consent.

• Subject is in general good health.

• If female, subject is postmenopausal for at least 2 years or surgically sterile.

• If female, subject is not pregnant and is not breast-feeding.

• Male or female between 18 and 55 years old, inclusive.

• If male, subject must be surgically sterile or practicing at least 1 method of birth control.

• Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria:

• Use of medications including over the counter and vitamines.

• Abuse of alcohol, drugs, or nicotine.

• Current diseases or disorders.

• History of cardiac disease.

• If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-072
Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

Other:
• ketoconazole
Tablet, see Arm Description for intervention information.

Drug:
• Placebo
Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

Locations

Country	Name	City	State
United States	Abbott Clinical Pharmaceutical Research Unit	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of pharmacokinetic results.		Study Days 1-13	No
Primary	Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.		Study Days -2 through 39	Yes
Secondary	Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.		Study Day 11-13	No