Clinical trial NCT00982826: Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072
Official title: A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Doses (7 Days) of ABT-072 and an Open-label Study to Evaluate the Effect of Food on the Pharmacokinetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Phase 1
Single and Multiple Ascending Dose
Food Effect
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.

Detailed description: The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

Eligibility criteria: Inclusion Criteria:

* Overall healthy subjects, non-childbearing females included.

Exclusion Criteria:

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Pregnant or breast-feeding female.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* 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 within the 6-month period preceding study drug administration.

Primary outcomes:
measure: To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions.
timeFrame: Up to 14 days post last dose.
measure: To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions.
timeFrame: 72 hours post last dose.
Secondary outcomes:
measure: To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.
timeFrame: 72 hours post last dose.
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 23742
state: Illinois
Study officials:
affiliation: Abbott
name: Daniel Cohen
role: STUDY_DIRECTOR
References: