Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. ABT-333 Tablet | Active Comparator | Three 400mg ABT-333 Tablets, BID |
|
| 2. ABT-333 Tablet | Active Comparator | Four 400mg ABT-333 Tablets, BID |
|
| 3. Placebo | Placebo Comparator | Three or four placebo tablets, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-333 | Drug | See arm description for more information |
|
| Measure | Description | 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 |
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cohen, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 20081 | Waukegan | Illinois | 60085 | United States |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C588260 | dasabuvir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | See arm description for more information |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |