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ABT-384 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| ABT-384 | EXPERIMENTAL | - |
| Low dose ABT-384 | EXPERIMENTAL | - |
| Mid dose ABT-384 | EXPERIMENTAL | - |
| High dose ABT-384 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABT-384 | DRUG | Doses will be administered daily for 5 days. |
| Matching placebo to ABT-384 | DRUG | Doses will be administered daily for 21 days |
Inclusion Criteria: * Age is between 18 and 55 years * Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: * Use of protocol-prohibited medications within 2 weeks pr...
ABT-384 is an investigational small molecule developed by Abbott Laboratories. It has been studied in Phase 1 clinical trials in healthy volunteers, including elderly subjects, rather than in patients with a specific disease. It is a selective inhibitor of the enzyme HSD11B1 and has not been approved for any indication.
ABT-384 targets HSD11B1, also known as 11-beta-hydroxysteroid dehydrogenase type 1. It acts as an inhibitor of this enzyme. HSD11B1 converts inactive cortisone into active cortisol, so inhibiting it reduces local cortisol production. This mechanism has been explored in metabolic and central nervous system research.
ABT-384 is developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. Abbott conducted the Phase 1 clinical program for the compound. No partnership or licensing arrangement for ABT-384 has been disclosed.
ABT-384 is in Phase 1 clinical development. Both of its recorded trials were Phase 1 studies and both are now completed, with no active trials ongoing. It is an investigational agent and has not been approved by the FDA for any use.
ABT-384 has been evaluated in two completed Phase 1 trials. NCT01009216 measured ABT-384 levels and pharmacodynamic activity in cerebrospinal fluid in 12 healthy male volunteers. NCT00968422 assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in 28 healthy elderly subjects aged 65 and older. Both were conducted in the United States.
Both ABT-384 trials were randomized, double-blind, and placebo-controlled Phase 1 studies in healthy volunteers, enrolling 40 participants in total. One trial focused on cerebrospinal fluid drug levels and pharmacodynamic activity in men, while the other examined safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects aged 65 years and older.