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
| Name | Class |
|---|---|
| Clinical Network Services (CNS) Pty Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is an Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Effect of Oral Doses of SCY-078 (Ibrexafungerp) on the Pharmacokinetics of Pravastatin Administered Orally to Healthy Subjects
The two period crossover study will consist of two treatments administered in random order separated by a minimum 10 day washout interval (between the last dose in the first period and the first dose in the subsequent period).
28 healthy adult male and female subjects will be enrolled to determine the effects of SCY-078 on the pharmacokinetics of a single-dose of PRA.
Subjects will undergo a screening visit 4 weeks prior to dosing.
Subjects will be randomized to a treatment sequence (AB or BA) in a crossover fashion:
Treatment A = Single oral 20-mg dose of PRA on Day 1 AM.
Treatment B = Twice daily (BID) oral doses of SCY-078 750 mg (5 X 150-mg tablets) on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed one hour later by a single 20-mg oral dose of PRA.
All subjects will be admitted to the clinical site on Day -1 in each period and will then fast overnight and will stay in the clinical site until the final procedures are performed in that treatment period, and then they may be discharged.
For Treatment B, on Day 1, 2, and 3, limited PK blood samples will be collected for SCY 078 assays.
For Treatments A on Days 1 and 2, and Treatment B on Day 3, serial PK blood samples will be collected for PRA assays.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single oral 20-mg dose of PRA 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 on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRA | Drug | Single oral 20-mg dose of PRA on Day 1 AM |
| |
| SCY-078 plus PRA |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of PRA administered with SCY-078, AUC | AUC 0-24 of PRA when taken with SCY-078. | 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of PRA administered with SCY-078, Cmax | Cmax PRA when taken with SCY-078 | 24 days |
| Pharmacokinetics of PRA administered with SCY-078, Tmax | Tmax of PRA when taken with SCY-078. |
Not provided
Inclusion Criteria:
NOTE: Women of childbearing potential must have a negative serum pregnancy test (β human chorionic gonadotropin [β-hCG]) at Screening visit and negative urine pregnancy test at each treatment period (conducted on Day -1 prior to dosing).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Limited Bright Building | Randwick | New South Wales | 2031 | Australia |
Not provided
| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
Not provided
Not provided
Not provided
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 20-mg dose of PRA 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 on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later.
Not provided
Not provided
Not provided
Not provided
| Drug |
Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later |
|
| 24 days |
| Pharmacokinetics of PRA administered with SCY-078, Half life (t1/2) | Half life (t1/2) of PRA when taken with SCY-078. | 24 days |
| Safety and tolerability of oral dosing of combination of PRA with SCY-078 | Incidence of treatment-related adverse events (AE) and discontinuations due to (AEs) | 6 weeks |