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| Name | Class |
|---|---|
| Clinical Network Services (CNS) Pty Ltd | INDUSTRY |
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This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.
The two-period crossover study will consist of two treatments administered in random order. Treatments will be separated by a minimum of 10 day wash-out (between last dose in the first period and first dose in the subsequent period). Healthy male and female subjects will will be enrolled to assess the effects on a single dose of dabigatran mesylate (DAB).
Subjects will be screened within 4 weeks prior to dosing and randomized to a treatment sequence (AB or BA) in a crossover fashion.
Treatment A: Single oral 150mg dose of DAB. Treatment B: Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750mg on Day and Day 2; and single oral AM doses of SCY-078 750mg on Day 3 and Day. On Day 3, a single 150mg dose of DAB will be administered 1 hour after the AM dose of SCY-078.
Subjects will fast overnight after being admitted to the clinic on Day -1 and will remain in the clinic until the final procedures are complete.
Twenty eight male and female subjects between 18 and 55 years (inclusive) will be enrolled into the study. Subjects who discontinue may be replaced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single oral 150-mg dose of DAB on Day 1 AM. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAB | Drug | Single oral 150-mg dose of DAB on Day 1 AM. |
| |
| SCY-078 plus DAB |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of DAB administered with SCY-078, AUC | AUC0-48 of DAB when taken with SCY-078 | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of DAB administered with SCY-078, Cmax | Cmax DAB when taken with SCY-078. | 17 days |
| Pharmacokinetics of DAB administered with SCY-078, Tmax | Tmax of DAB when taken with SCY-078. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
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Subjects will be randomized to a treatment sequence (AB or BA) in a crossover fashion with a minimum 10-day washout period between treatments.
Treatment A = Single oral 150-mg dose of DAB on Day 1 AM. Treatment B = 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.
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| 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. |
|
| 17 days |
| Pharmacokinetics of DAB administered with SCY-078, Half Life | Half Life of DAB when taken with SCY-078. | 17 Days |
| Safety and tolerability of oral dosing of combination of DAB with SCY-078 | Incidence of treatment-related adverse events (AE) and discontinuations due to (AEs) | 7 weeks |