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

NCT04092751 | Completed Phase 1 FDA Drug

• 1 other identifier: SCY-078-115
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Pharmacokinetics

Keywords

SCY-078; Ibrexafungerp; Pravastatin; Healthy Subjects; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of PRA administered with SCY-078, AUC

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

  24 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Treatment A

EXPERIMENTAL

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

Drug: PRA

Treatment B

EXPERIMENTAL

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.

Drug: SCY-078 plus PRA

Interventions

PRA DRUG

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

Treatment A

SCY-078 plus PRA DRUG

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 B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• is a male or female between 18 to 55 years, inclusive, of age at the prestudy (screening) visit (time of signing the Informed Consent).
• has a Body Mass Index (BMI) 18.0 to 32 kg/m2 at the prestudy (screening) visit.
• 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.
• has been is a nonsmoker and/or has not used nicotine or nicotine-containing products for approximately 6 months prior to screening.
• is willing and able to understand and provide signed informed consent and understands the study procedures and agrees to participate in the study.
• 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).

You may not qualify if:

• has a contra-indication to Pravachol® (pravastatin sodium).
• has severe liver disease or chronically elevated liver enzymes.
• is pregnant or lactating
• has a history of uncontrolled or unstable cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematopoietic, neoplastic, and/or neurological disease.
• has a current or recent (within 3 months) gastrointestinal (GI) disease or any GI surgery that could impact absorption of study drug.
• 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.
• has a QTcF interval \>480 msec at the Screening or Day -1 visits of the study.
• 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.
• has consumed any alcohol within 7 days before dosing SCY-078 prior to dose of study medication or has a history of alcohol abuse.
• has a positive drug and or alcohol screen at screening and or (each) admission to the clinical research center.
• 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.
• has been participated in a clinical investigation of any drug, biological, or other investigational therapy, device or procedure 30 days before dosing
• 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.

Sponsors & Collaborators

• Scynexis, Inc.: lead
• Clinical Network Services (CNS) Pty Ltd: collaborator

Study Sites (1)

Scientia Clinical Research Limited Bright Building

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Interventions

ibrexafungerp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 17, 2019
• Study Start: November 22, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

AU (1)