Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects

NCT04092725 | Completed Phase 1 FDA Drug

• 1 other identifier: SCY-078-108
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.

Conditions

Pharmacokinetics

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of DAB administered with SCY-078, AUC

  AUC0-48 of DAB when taken with SCY-078

  17 days

Secondary Outcomes (4)

• Pharmacokinetics of DAB administered with SCY-078, Cmax

  17 days

• Pharmacokinetics of DAB administered with SCY-078, Tmax

  17 days

• Pharmacokinetics of DAB administered with SCY-078, Half Life

  17 Days

• Safety and tolerability of oral dosing of combination of DAB with SCY-078

  7 weeks

Study Arms (2)

Treatment A

EXPERIMENTAL

Single oral 150-mg dose of DAB on Day 1 AM.

Drug: DAB

Treatment B

EXPERIMENTAL

Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.

Drug: SCY-078 plus DAB

Interventions

DAB DRUG

Single oral 150-mg dose of DAB on Day 1 AM.

Treatment A

SCY-078 plus DAB DRUG

Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.

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 - 32 kg/m2 at the prestudy (screening) visit. BMI is calculated by taking the subject's weight in kg and dividing by the subject's height in meters, squared.
• is judged to be in good physical and mental health based on medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug. Subjects will be enrolled at the discretion of the investigator.
• is a nonsmoker and has not used nicotine or nicotine containing products for 6 months prior to screening.
• is willing and able to sign the informed consent and understands the study procedures and agrees to comply with all restrictions and participate in the study.
• is not pregnant or lactating (for women of childbearing potential) and must agree to use adequate double barrier birth control.

You may not qualify if:

• has a contra-indication to PRADAXA® (dabigatran etexilate mesylate)
• has a prior history of convulsions, or hemorrhagic disease
• has a history of peptic ulcer disease that is currently being treated.
• is pregnant or is lactating
• has a history of uncontrolled or unstable cardiovascular, respiratory, renal, hepatic, gastrointestinal, endocrine, hematopoietic, neoplastic, and/or neurological disease.
• has had any major surgery within 30 days of dosing with study drug.
• has 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) or charbroiled meats from 4 days prior to the dose of study medication.
• has consumed any alcohol within 7 days prior to the dose of study medication.
• is a smoker or has used tobacco or any nicotine-containing products within the 6 months prior to screening.
• has a positive test result for drugs of abuse, alcohol, or cotinine at screening or before dosing.
• has 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 PRADAXA® (dabigatran etexilate mesylate), or its inactive ingredients.

Sponsors & Collaborators

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

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, 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 150-mg dose of DAB 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 single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 17, 2019
• Study Start: September 9, 2019
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

AU (1)