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DAB

Phase 1

Pharmacokinetics | Small molecule | Other |SCYNEXIS, Inc.|Last Updated: Sep 2, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

DAB · 1 trial · 1 indication

Phase 1 1
NCT04092725Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy SubjectsPharmacokinetics
COMPLETED36 Analytics
PHASE1COMPLETED
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
Pharmacokinetics
NCT0409272536
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Study Endpoints

Primary Endpoints

Pharmacokinetics of DAB administered with SCY-078, AUC
17 days

AUC0-48 of DAB when taken with SCY-078

Secondary Endpoints

Pharmacokinetics of DAB administered with SCY-078, Cmax
17 days
Pharmacokinetics of DAB administered with SCY-078, Tmax
17 days
Pharmacokinetics of DAB administered with SCY-078, Half Life
17 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment AEXPERIMENTALSingle oral 150-mg dose of DAB on Day 1 AM.
Treatment BEXPERIMENTALTwice 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.

Interventions

NameTypeDescription
DABDRUGSingle oral 150-mg dose of DAB on Day 1 AM.
SCY-078 plus DABDRUGTwice 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.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Australia
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Frequently asked questions about DAB

What is DAB?

DAB is an investigational small molecule being studied for pharmacokinetics. It is currently in Phase 1 clinical development. The drug is being developed by SCYNEXIS, Inc., a biopharmaceutical company. DAB is not approved by the FDA and remains in clinical trials.

What is DAB used for?

DAB is being studied for pharmacokinetics, which involves how the drug is absorbed, distributed, metabolized, and excreted in the body. It is currently in Phase 1 clinical trials to evaluate its pharmacokinetic profile. The drug is not approved for any medical condition.

Who makes DAB?

DAB is being developed by SCYNEXIS, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's pharmacokinetics. SCYNEXIS is the sponsor of the ongoing research on DAB.

What phase is DAB in?

DAB is in Phase 1 clinical development. It is an investigational drug being studied for pharmacokinetics. The drug is not FDA approved and is still in early-stage clinical trials. One Phase 1 trial has been completed.

What clinical trials is DAB in?

DAB has one completed Phase 1 clinical trial with the identifier NCT04092725. The study evaluated the effect of SCY-078 on the pharmacokinetics of dabigatran in healthy subjects. The trial was conducted in Australia with 36 participants.

Is DAB the same as SCY-078?

DAB is the drug being studied in the clinical trial, while SCY-078 is the investigational drug being evaluated for its effect on DAB's pharmacokinetics. In the trial, DAB is the substrate drug, and SCY-078 is the interacting drug. They are not the same compound.