Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects
NCT04092751 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2020-09-02
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
Conditions
- Pharmacokinetics
Interventions
- 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
Sponsors & Collaborators
-
Clinical Network Services (CNS) Pty Ltd
collaborator INDUSTRY -
Scynexis, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-11-22
- Primary Completion
- 2019-12-20
- Completion
- 2019-12-20
- FDA Drug
- Yes
Countries
- Australia
Study Locations
More Related Trials
-
Effect of BI 201335 Mediated UGT1A1 (Uridine-diphosphate-glucuronosyltransferases) Inhibition in Healthy Volunteers
NCT02182375 ·Status: COMPLETED ·Phase: PHASE1
-
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
NCT06048302 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine
NCT02264041 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects
NCT00615212 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
NCT03774576 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
NCT03774355 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HGP1602 in Healthy Subjects
NCT04084184 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
NCT04466514 ·Status: COMPLETED ·Phase: PHASE1
-
GSK1349572 Drug Interaction Study With Etravirine
NCT00774111 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Absolute Bioavailability of Oral PCI-32765 and the Effect of Grapefruit Juice on the Bioavailability of PCI-32765 in Healthy Participants
NCT01866033 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects
NCT05967377 ·Status: COMPLETED ·Phase: PHASE1
-
Hepatic Impairment Study
NCT00829231 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers
NCT03674060 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Absolute Bioavailability and Pharmacokinetics of Simeprevir (TMC435) Administered as Single Oral Doses of TMC435 and an Intravenous Microdose of [3H]-TMC435 in Healthy Male Patients
NCT01707342 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
NCT03465059 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics and Safety of IN-M00007 and IN-R00007 in Healthy Adult Volunteers
NCT07311811 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1903
NCT04762407 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Volunteers
NCT07297693 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study to Investigate the Recovery, Excretion and Pharmacokinetics of [14C]-GSK2140944 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects
NCT02000765 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About if the Study Medicine Called Ibuzatrelvir Changes How the Body Process the Other Medicine Dabigatran Etexilate in Healthy Adults
NCT06693518 ·Status: COMPLETED ·Phase: PHASE1
-
Single Dose, Pharmacokinetic, Safety, Tolerability and QTc Study of GSK1278863 in Healthy Volunteers
NCT02293148 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
NCT04516382 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects
NCT02266485 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Tolerability and Pharmacokinetic of BI 411034
NCT01581684 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers
NCT01168934 ·Status: COMPLETED ·Phase: PHASE1