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Report for Clinical Trial NCT04092725

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT04092725 Pharmacokinetics

2 Interventions

Name: DAB

Description: Single oral 150-mg dose of DAB on Day 1 AM.
Type: Drug
Group Labels: 1

Treatment A

Name: SCY-078 plus DAB

Description: 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.
Type: Drug
Group Labels: 1

Treatment B


Primary Outcomes

Description: AUC0-48 of DAB when taken with SCY-078

Measure: Pharmacokinetics of DAB administered with SCY-078, AUC

Time: 17 days

Secondary Outcomes

Description: Cmax DAB when taken with SCY-078.

Measure: Pharmacokinetics of DAB administered with SCY-078, Cmax

Time: 17 days

Description: Tmax of DAB when taken with SCY-078.

Measure: Pharmacokinetics of DAB administered with SCY-078, Tmax

Time: 17 days

Description: Half Life of DAB when taken with SCY-078.

Measure: Pharmacokinetics of DAB administered with SCY-078, Half Life

Time: 17 Days

Description: Incidence of treatment-related adverse events (AE) and discontinuations due to (AEs)

Measure: Safety and tolerability of oral dosing of combination of DAB with SCY-078

Time: 7 weeks

Purpose: Other

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 Q12H

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. --- Q12H ---



HPO Nodes