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

NCT00909636 | Completed Phase 1

• 1 other identifier: M11-031
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

multiple ascending doses (MAD)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

1. ABT-333 Tablet

ACTIVE COMPARATOR

Three 400mg ABT-333 Tablets, BID

Drug: ABT-333

2. ABT-333 Tablet

ACTIVE COMPARATOR

Four 400mg ABT-333 Tablets, BID

Drug: ABT-333

3. Placebo

PLACEBO COMPARATOR

Three or four placebo tablets, BID

Drug: Placebo

Interventions

ABT-333 DRUG

See arm description for more information

1. ABT-333 Tablet; 2. ABT-333 Tablet

Placebo DRUG

See arm description for more information

3. Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Site Reference ID/Investigator# 20081

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

dasabuvir

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, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 28, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: October 13, 2010

Record last verified: 2010-09

Locations

US (1)