Status:
COMPLETED
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
Lead Sponsor:
Scynexis, Inc.
Collaborating Sponsors:
Clinical Network Services (CNS) Pty Ltd
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Detailed Description
The two-period crossover study will consist of two treatments administered in random order. Treatments will be separated by a minimum of 10 day wash-out (between last dose in the first period and firs...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04092725
Start Date
September 9 2019
End Date
January 3 2020
Last Update
September 2 2020
Active Locations (1)
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1
CMAX
Adelaide, South Australia, Australia, 5000