HCV Infection
Conditions
Keywords
multiple ascending doses (MAD)
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.
Interventions
DRUGABT-333
See arm description for more information
DRUGPlacebo
See arm description for more information
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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 |
Countries
United States
Outcome results
None listed