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

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: HCV Infection
• Intervention / Treatment: Drug: ABT-333; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Waukegan, Illinois, United States, 60085
      • Site Reference ID/Investigator# 20081

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1. ABT-333 Tablet; Three 400mg ABT-333 Tablets, BID	Drug: ABT-333; See arm description for more information
Active Comparator: 2. ABT-333 Tablet; Four 400mg ABT-333 Tablets, BID	Drug: ABT-333; See arm description for more information
Placebo Comparator: 3. Placebo; Three or four placebo tablets, BID	Drug: Placebo; See arm description for more information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess multiple dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.	10 days
Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws.	10 days

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 27, 2009
• First Submitted That Met QC Criteria: May 27, 2009
• First Posted (Estimate): May 28, 2009

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 11, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: multiple ascending doses (MAD)
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: M11-031