Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DAB · 1 trial · 1 indication
AUC0-48 of DAB when taken with SCY-078
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Single oral 150-mg dose of DAB on Day 1 AM. |
| Treatment B | EXPERIMENTAL | Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078. |
| Name | Type | Description |
|---|---|---|
| DAB | DRUG | Single oral 150-mg dose of DAB on Day 1 AM. |
| SCY-078 plus DAB | DRUG | Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078. |
Inclusion Criteria: 1. is a male or female between 18 to 55 years, inclusive, of age at the prestudy (screening) visit (time of signing the Informed Consent). 2. has a Body Mass Index (BMI) 18.0 - 32 kg/m2 at the prestudy (screening) visit. BMI is calculated by taking the subject's weight in kg and...
DAB is an internal shorthand for dabigatran, an anticoagulant medication used in a Phase 1 drug interaction study sponsored by SCYNEXIS, Inc. The trial evaluated how SCY-078 affects the pharmacokinetics of dabigatran in healthy adult subjects. DAB is not a SCYNEXIS development candidate itself; it was the comparator drug in that study.
SCYNEXIS, Inc., which trades on the Nasdaq under the ticker SCYX, sponsored the Phase 1 study involving DAB. SCYNEXIS is a biopharmaceutical company. The trial examined the effect of the company's compound SCY-078 on the pharmacokinetics of dabigatran in healthy subjects.
DAB was studied in a Phase 1 clinical trial, NCT04092725, which has been completed. The study enrolled 36 healthy adult volunteers in Australia and was a controlled, randomized design without double blinding. It assessed the effect of SCY-078 on the pharmacokinetics of dabigatran.
DAB was evaluated in one completed Phase 1 trial, NCT04092725, titled a study to evaluate the effect of SCY-078 on the pharmacokinetics of dabigatran in healthy subjects. The trial enrolled 36 participants, was randomized and controlled, and was conducted in Australia with healthy volunteers aged 18 years and older.
DAB refers to dabigatran, an anticoagulant. In the SCYNEXIS-sponsored Phase 1 study NCT04092725, dabigatran was used as the probe drug to measure whether SCY-078 alters its pharmacokinetics. The trial enrolled 36 healthy adult subjects in Australia and has been completed.