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Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

NCT04543370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-01-28

No results posted yet for this study

Summary

Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 \[CYP\]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.

Conditions

  • Healthy

Interventions

DRUG

Edasalonexent 2000 mg TID

CAT-1004 capsules

DRUG

Midazolam 2 MG/ML

2 mg/ml syrup

DRUG

Deflazacort 36Mg Tab

36 mg tablets

Sponsors & Collaborators

  • Catabasis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Joanne Donovan, MD, PhD · Chief Medical Officer, Catabasis

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-08-08
Primary Completion
2020-09-06
Completion
2020-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04543370 on ClinicalTrials.gov