MedTrace Logo

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

NCT04092725 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-09-02

No results posted yet for this study

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

Interventions

DRUG

DAB

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

DRUG

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.

Sponsors & Collaborators

  • Clinical Network Services (CNS) Pty Ltd

    collaborator INDUSTRY

  • Scynexis, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2020-01-03
Completion
2020-01-03
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092725 on ClinicalTrials.gov