Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04092751
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2019-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects
Sponsor:
Scynexis, Inc.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: