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

Abbott

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: ABT-333; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909636

M11-031

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups, including a placebo group

1. ABT-333 Tablet

Active Comparator group

Description:

Three 400mg ABT-333 Tablets, BID

Treatment:

Drug: ABT-333

2. ABT-333 Tablet

Active Comparator group

Description:

Four 400mg ABT-333 Tablets, BID

Treatment:

Drug: ABT-333

3. Placebo

Placebo Comparator group

Description:

Three or four placebo tablets, BID

Treatment:

Drug: Placebo