Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

NCT00982826 | Completed Phase 1

• 1 other identifier: M11-057
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Phase 1; Single and Multiple Ascending Dose; Food Effect

Outcome Measures

Primary Outcomes (2)

• To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions.

  Up to 14 days post last dose.

• To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions.

  72 hours post last dose.

Secondary Outcomes (1)

• To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.

  72 hours post last dose.

Study Arms (5)

1

EXPERIMENTAL

ABT-072 tablet single ascending dose

Drug: ABT-072

2

EXPERIMENTAL

Placebo tablet

Drug: Placebo

3

EXPERIMENTAL

ABT-072 tablet administered under non-fasting conditions.

Drug: ABT-072

4

EXPERIMENTAL

ABT-072 tablet administered under fasting conditions

Drug: ABT-072

5

EXPERIMENTAL

ABT-072 tablet multiple ascending dose

Drug: ABT-072

Interventions

ABT-072 DRUG

See Arms information for a detailed description.

1; 3; 4; 5

Placebo DRUG

See Arms information for a detailed description.

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overall healthy subjects, non-childbearing females included.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 23742

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ABT-072

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Daniel Cohen

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2010-09

Locations

US (1)