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

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

Sponsors

Lead sponsor: Scynexis, Inc.

Collaborator: Clinical Network Services (CNS) Pty Ltd

Source Scynexis, Inc.
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

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.

Overall Status Not yet recruiting
Start Date October 22, 2019
Completion Date November 29, 2019
Primary Completion Date November 29, 2019
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacokinetics of PRA administered with SCY-078, AUC 24 days
Secondary Outcome
Measure Time Frame
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
Safety and tolerability of oral dosing of combination of PRA with SCY-078 6 weeks
Enrollment 28
Condition
Intervention

Intervention type: Drug

Intervention name: PRA

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

Arm group label: Treatment A

Intervention type: Drug

Intervention name: SCY-078 plus PRA

Description: 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

Arm group label: Treatment B

Eligibility

Criteria:

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 (β human chorionic gonadotropin [β-hCG]) at Screening visit and negative urine pregnancy test at each treatment period (conducted on Day -1 prior to dosing).

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.

Gender: All

Minimum age: 18 Years

Maximum age: 55 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Nkechi Azie, MD

Phone: 201 688 2243

Email: [email protected]

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Treatment A

Arm group type: Experimental

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

Arm group label: Treatment B

Arm group type: Experimental

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: Subjects will be randomized to a treatment sequence (AB or BA) in a crossover fashion with a minimum 10-day washout period between treatments
Treatment A = Single oral 20-mg dose of PRA on Day 1 AM. 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.

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov