NCT04092751

Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	PRA	Single oral 20-mg dose of PRA on Day 1 AM
DRUG	SCY-078 plus PRA	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

Timeline

• Start date: 2019-11-22
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2019-09-17
• Last updated: 2020-09-02

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study