A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet

NCT ID: NCT00909636

Last Updated: 2010-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.

Conditions

HCV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1. ABT-333 Tablet

Three 400mg ABT-333 Tablets, BID

Group Type: ACTIVE_COMPARATOR

ABT-333

Intervention Type: DRUG

See arm description for more information

2. ABT-333 Tablet

Four 400mg ABT-333 Tablets, BID

Group Type: ACTIVE_COMPARATOR

ABT-333

Intervention Type: DRUG

See arm description for more information

3. Placebo

Three or four placebo tablets, BID

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

See arm description for more information

Interventions

ABT-333

See arm description for more information

Intervention Type: DRUG

Placebo

See arm description for more information

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• overall healthy subjects between the ages of 18 to 55 years old;
• if female, subject must be either postmenopausal for at least 2 years or surgically sterile;
• females must have negative results for pregnancy tests performed;
• if male, subject must be surgically sterile or practicing at least 1 of the following methods of birth control:

• partner(s) using IUD,
• partner(s) using oral, injected or implanted methods of hormonal contraceptives,
• subject and/or partner(s) using double-barrier method;
• Body Mass Index is 18 to 29, inclusive

Exclusion Criteria

• history of significant sensitivity to any drug;
• positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab;
• history of gastrointestinal issues or procedures;
• history of seizures, diabetes or cancer (except basal cell carcinoma);
• 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;
• donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
• clinically significant abnormal screening laboratory analyses and ECGs:

• ALT > ULN,
• AST > ULN,
• ECG with QTcF>450 msec in females and >430 msec in males,
• or ECG with 2nd or 3rd degree atrioventricular block;
• current enrollment in another clinical study;
• previous enrollment in this study;
• recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
• pregnant or breastfeeding female;
• requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis or use within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication;
• use of known inhibitors or inducers of cytochrome P450 3A or cytochrome P450 2C8 within 1 month prior to study drug administration;
• positive screen for drugs of abuse, alcohol, or cotinine;
• receipt of any drug by injection within 30 days prior to study drug administration;
• receipt of any investigational product within a time period equal to 10 half-lives of the product or a minimum of 6 weeks prior to study drug administration;
• consumption of alcohol within 48 hours prior to study drug administration;
• consumption of grapefruit, grapefruit products, star fruit, or star fruit products within the 72-hour period prior to study drug administration;
• consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-333;
• history of cardiac disease, including family history of long-QT syndrome or unexplained sudden death.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Daniel Cohen, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 20081

Waukegan, Illinois, United States

Countries

United States

Other Identifiers

M11-031

Identifier Type: -

Identifier Source: org_study_id