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PRA

Phase 1

Undisclosed | Small molecule | Other |SCYNEXIS, Inc.|Trials Updated: Sep 2, 2020

PRA development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

PRA clinical trials

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
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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?

PRA is an internal shorthand used by SCYNEXIS, Inc. for pravastatin, a small molecule drug that was studied as a comparator in a Phase 1 pharmacokinetic trial. The trial examined how another SCYNEXIS compound affects the way the body processes pravastatin in healthy volunteers.

Who makes PRA?

PRA is not a SCYNEXIS development asset. SCYNEXIS, Inc., which trades on the Nasdaq under the ticker SCYX, used pravastatin as a probe drug in a drug-drug interaction study. Pravastatin itself is a widely available generic medicine, and SCYNEXIS does not develop or commercialize it.

What phase is PRA in?

PRA was used in a single completed Phase 1 trial sponsored by SCYNEXIS, Inc. That study enrolled 28 healthy adult volunteers in Australia and has finished. PRA is not an investigational new drug in SCYNEXIS's pipeline; it served as a comparator to measure pharmacokinetic interactions.

What clinical trials is PRA in?

PRA appears in one completed trial, NCT04092751, titled Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects. It was a Phase 1, randomized, controlled study with 28 enrolled participants, conducted in Australia in healthy volunteers aged 18 years and older.

Is PRA the same as pravastatin?

Yes. PRA is shorthand for pravastatin, the small molecule statin used in SCYNEXIS's Phase 1 drug-drug interaction study. In trial NCT04092751, pravastatin was given to healthy volunteers to assess whether SCY-078 (ibrexafungerp) changes its pharmacokinetics.