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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04092751




Registration number
NCT04092751
Ethics application status
Date submitted
10/09/2019
Date registered
17/09/2019
Date last updated
2/09/2020

Titles & IDs
Public title
Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
SCY-078-115
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRA
Treatment: Drugs - SCY-078 plus PRA

Experimental: Treatment A - Single oral 20-mg dose of PRA on Day 1 AM

Experimental: Treatment B - 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.


Treatment: Drugs: PRA
Single oral 20-mg dose of PRA on Day 1 AM

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics of PRA administered with SCY-078, AUC
Timepoint [1] 0 0
24 days
Secondary outcome [1] 0 0
Pharmacokinetics of PRA administered with SCY-078, Cmax
Timepoint [1] 0 0
24 days
Secondary outcome [2] 0 0
Pharmacokinetics of PRA administered with SCY-078, Tmax
Timepoint [2] 0 0
24 days
Secondary outcome [3] 0 0
Pharmacokinetics of PRA administered with SCY-078, Half life (t1/2)
Timepoint [3] 0 0
24 days
Secondary outcome [4] 0 0
Safety and tolerability of oral dosing of combination of PRA with SCY-078
Timepoint [4] 0 0
6 weeks

Eligibility
Key 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 history, physical examination, vital
sign measurements, electrocardiogram (ECG), and laboratory safety tests performed at
the prestudy (screening) visit and/or prior to administration of the initial dose of
study drug.

4. has been is a nonsmoker and/or has not used nicotine or nicotine-containing products
for approximately 6 months prior to screening.

5. is willing and able to understand and provide signed informed consent and understands
the study procedures and agrees to participate in the study.

6. is not pregnant or lactating (for women of childbearing potential) and must agree to
use adequate double barrier birth control.

NOTE: Women of childbearing potential must have a negative serum pregnancy test (ß human
chorionic gonadotropin [ß-hCG]) at Screening visit and negative urine pregnancy test at
each treatment period (conducted on Day -1 prior to dosing).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. has a contra-indication to Pravachol® (pravastatin sodium).

2. has severe liver disease or chronically elevated liver enzymes.

3. is pregnant or lactating

4. has a history of uncontrolled or unstable cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrine, hematopoietic, neoplastic, and/or neurological disease.

5. has a current or recent (within 3 months) gastrointestinal (GI) disease or any GI
surgery that could impact absorption of study drug.

6. has a history of any illness that, in the opinion of the investigator, could confound
the results of the study or pose an additional risk to the subject by their
participation in the study.

7. has a QTcF interval >480 msec at the Screening or Day -1 visits of the study.

8. subject consumed Seville or blood oranges, grapefruit or grapefruit juice, or mulberry
juice , as well as vegetables from the mustard green family (e.g., kale, broccoli,
watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) and or
charbroiled meats from 4 days prior to the dose of study medication.

9. has consumed any alcohol within 7 days before dosing SCY-078 prior to dose of study
medication or has a history of alcohol abuse.

10. has a positive drug and or alcohol screen at screening and or (each) admission to the
clinical research center.

11. is a smoker or has used tobacco or any nicotine-containing products within the 6
months prior to the first dosing in the study screening.

12. has been participated in a clinical investigation of any drug, biological, or other
investigational therapy, device or procedure 30 days before dosing

13. has a history of an allergic reaction to SCY-078 or any of its excipients, or is
allergic to Pravachol® (pravastatin sodium), or its inactive ingredients.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2019
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Limited Bright Building - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Scynexis, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Clinical Network Services (CNS) Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04092751
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04092751