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PRA

Phase 1

Pharmacokinetics | Small molecule | Other |SCYNEXIS, Inc.|Last Updated: Sep 2, 2020

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

PRA · 1 trial · 1 indication

Phase 1 1
NCT04092751Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy SubjectsPharmacokinetics
COMPLETED28 Analytics
PHASE1COMPLETED
Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects
PharmacokineticsUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics of PRA administered with SCY-078, AUC
24 days

AUC 0-24 of PRA when taken with SCY-078.

Secondary Endpoints

Pharmacokinetics of PRA administered with SCY-078, Cmax
24 days
Pharmacokinetics of PRA administered with SCY-078, Tmax
24 days
Pharmacokinetics of PRA administered with SCY-078, Half life (t1/2)
24 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALSingle oral 20-mg dose of PRA on Day 1 AM
Treatment BEXPERIMENTALTwice 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.

Interventions

NameTypeDescription
PRADRUGSingle oral 20-mg dose of PRA on Day 1 AM
SCY-078 plus PRADRUGTwice 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
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. is a male or female between 18 to 55 years, inclusive, of age at the prestudy (screening) visit (time of signing the Informed Consent). 2. has a Body Mass Index (BMI) 18.0 to 32 kg/m2 at the prestudy (screening) visit. 3. is judged to be in good health based on medical histor...

Countries:Australia
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Frequently asked questions about PRA

What is PRA used for?

PRA is a small molecule drug being studied for pharmacokinetics, which is the measurement of how a drug is absorbed, distributed, metabolized, and excreted in the body. It is currently in Phase 1 clinical development as an investigational agent.

Who makes PRA?

PRA is being developed by SCYNEXIS, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SCYX. The company is conducting clinical research to evaluate the drug's pharmacokinetic properties.

What phase is PRA in?

PRA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study has been completed, and the drug is still in the early stages of clinical research.

What clinical trials is PRA in?

PRA has one completed clinical trial registered under NCT04092751. This study evaluated the effect of SCY-078 (Ibrexafungerp) on the pharmacokinetics of Pravastatin in healthy subjects. The trial enrolled 28 participants in Australia and was a controlled, randomized study.

Is PRA the same as pravastatin?

PRA is the abbreviation for pravastatin, a statin medication used to lower cholesterol. In the clinical trial NCT04092751, pravastatin was studied as a substrate to assess potential drug interactions with SCY-078 (Ibrexafungerp), an antifungal agent developed by SCYNEXIS.