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

2019-09-23 04:51:44 | BioPortfolio

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.

Study Design

Conditions

Pharmacokinetics

Intervention

DAB, SCY-078 plus DAB

Status

Not yet recruiting

Source

Scynexis, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-23T04:51:44-0400

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