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

Pharmacokinetics Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092725
• Other study ID #: SCY-078-108
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2019
• Est. completion date: January 3, 2020

Study information

• Verified date: August 2020
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 first dose in the subsequent period). Healthy male and female subjects will will be enrolled to assess the effects on a single dose of dabigatran mesylate (DAB).

Subjects will be screened within 4 weeks prior to dosing and randomized to a treatment sequence (AB or BA) in a crossover fashion.

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

Subjects will fast overnight after being admitted to the clinic on Day -1 and will remain in the clinic until the final procedures are complete.

Twenty eight male and female subjects between 18 and 55 years (inclusive) will be enrolled into the study. Subjects who discontinue may be replaced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Scynexis, Inc.	Clinical Network Services (CNS) Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of DAB administered with SCY-078, AUC	AUC0-48 of DAB when taken with SCY-078	17 days
Secondary	Pharmacokinetics of DAB administered with SCY-078, Cmax	Cmax DAB when taken with SCY-078.	17 days
Secondary	Pharmacokinetics of DAB administered with SCY-078, Tmax	Tmax of DAB when taken with SCY-078.	17 days
Secondary	Pharmacokinetics of DAB administered with SCY-078, Half Life	Half Life of DAB when taken with SCY-078.	17 Days
Secondary	Safety and tolerability of oral dosing of combination of DAB with SCY-078	Incidence of treatment-related adverse events (AE) and discontinuations due to (AEs)	7 weeks