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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04092725




Registration number
NCT04092725
Ethics application status
Date submitted
3/09/2019
Date registered
17/09/2019
Date last updated
2/09/2020

Titles & IDs
Public title
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran 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 Dabigatran Administered Orally to Healthy Subjects
Secondary ID [1] 0 0
SCY-078-108
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 - DAB
Treatment: Drugs - SCY-078 plus DAB

Experimental: Treatment A - Single oral 150-mg dose of DAB 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 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: Drugs: DAB
Single oral 150-mg dose of DAB on Day 1 AM.

Treatment: Drugs: SCY-078 plus DAB
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics of DAB administered with SCY-078, AUC
Timepoint [1] 0 0
17 days
Secondary outcome [1] 0 0
Pharmacokinetics of DAB administered with SCY-078, Cmax
Timepoint [1] 0 0
17 days
Secondary outcome [2] 0 0
Pharmacokinetics of DAB administered with SCY-078, Tmax
Timepoint [2] 0 0
17 days
Secondary outcome [3] 0 0
Pharmacokinetics of DAB administered with SCY-078, Half Life
Timepoint [3] 0 0
17 Days
Secondary outcome [4] 0 0
Safety and tolerability of oral dosing of combination of DAB with SCY-078
Timepoint [4] 0 0
7 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 - 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.
3. 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.
4. is a nonsmoker and has not used nicotine or nicotine containing products for 6 months prior to screening.
5. 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.
6. is not pregnant or lactating (for women of childbearing potential) and must agree to use adequate double barrier birth control.
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 PRADAXA® (dabigatran etexilate mesylate)
2. has a prior history of convulsions, or hemorrhagic disease
3. has a history of peptic ulcer disease that is currently being treated.
4. is pregnant or is lactating
5. has a history of uncontrolled or unstable cardiovascular, respiratory, renal, hepatic, gastrointestinal, endocrine, hematopoietic, neoplastic, and/or neurological disease.
6. has had any major surgery within 30 days of dosing with study drug.
7. 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.
8. has consumed any alcohol within 7 days prior to the dose of study medication.
9. is a smoker or has used tobacco or any nicotine-containing products within the 6 months prior to screening.
10. has a positive test result for drugs of abuse, alcohol, or cotinine at screening or before dosing.
11. has participated in a clinical investigation of any drug, biological, or other investigational therapy, device or procedure 30 days before dosing
12. 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.

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
9/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/01/2020
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

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 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.
Trial website
https://clinicaltrials.gov/study/NCT04092725
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/study/NCT04092725