Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-072 · 5 trials · 2 indications
Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.
Single Dose Pharmacokinetic profile evaluation
| Arm | Type | Description |
|---|---|---|
| ABT-072 Tablet | ACTIVE_COMPARATOR | ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3 |
| Placebo | PLACEBO_COMPARATOR | Placebo Tablet, QD, single doses, groups 1-3 |
| 1 | EXPERIMENTAL | ABT-072 tablet single ascending dose |
| 2 | EXPERIMENTAL | Placebo tablet |
| 3 | EXPERIMENTAL | ABT-072 tablet administered under non-fasting conditions. |
| 4 | EXPERIMENTAL | ABT-072 tablet administered under fasting conditions |
| 5 | EXPERIMENTAL | ABT-072 tablet multiple ascending dose |
| Tablet 1 vs. Capsule | ACTIVE_COMPARATOR | Single dose of 2 x 50 mg tablets (Tablet 1) vs. 100 mg ABT-072 (contents of capsules) suspended in liquid. |
| Tablet 2 vs. Capsule | ACTIVE_COMPARATOR | Single dose of 2 x 50 mg tablets (Tablet 2) vs. 100 mg ABT-072 (contents from capsules) suspended in liquid. |
| Name | Type | Description |
|---|---|---|
| ABT-072 | DRUG | See arm description for more information |
| Placebo | DRUG | See arm description for more information |
| ketoconazole | OTHER | Tablet, see Arm Description for intervention information. |
Inclusion Criteria: * Overall healthy adult Japanese males Exclusion Criteria: * Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medi...
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ABT-072 is an investigational small molecule being developed for the treatment of Hepatitis C virus (HCV) infection. It was studied in patients with HCV genotype 1 infection, as well as in healthy volunteers, to evaluate its safety, tolerability, and pharmacokinetic profile.
ABT-072 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug has completed Phase 1 clinical trials, but it is not approved and remains in clinical development.
ABT-072 is in Phase 1 clinical development. All four clinical trials for ABT-072 have been completed, with no active trials currently ongoing. The drug is investigational and has not received FDA approval.
ABT-072 has been studied in four completed Phase 1 trials. These include NCT00752687, which enrolled 100 healthy and HCV genotype 1-infected adults in the United States, and NCT00890318, a multiple-dose study in 32 healthy subjects. Other trials are NCT00982826 and NCT01081483.
ABT-072 is the primary name used for this investigational compound. No alternative names have been identified for ABT-072 in the available clinical trial data. It is a distinct small molecule being evaluated for the treatment of Hepatitis C.