Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

January 27, 2021 updated by: Catabasis Pharmaceuticals

A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, fixed-sequence DDI and cardiodynamic study in healthy adult subjects.

Twenty-six (26), healthy, adult male and female (non-childbearing potential) subjects will be enrolled.

Screening of subjects will occur within 28 days prior to the first dosing.

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.

Visit assessments include Clinical laboratory tests, Safety ECGs and Cardiodynamic ECGs. Subjects will be housed on Day -3 of Period 1, until after the 24-hour blood draw and/or study procedures are completed on Day 12 of Period 2.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy, adult, male or female (of non-childbearing potential), 18-55 years of age, inclusive at Screening
  • Non-smoker
  • Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 at Screening
  • Medically healthy with no clinically significant medical history
  • Ability to swallow multiple capsules/tablets.
  • Ability to understand the study procedures, willing and able to comply with the protocol

Exclusion Criteria:

  • History or presence of clinically significant medical condition or disease
  • History or presence of hypersensitivity to edasalonexent or excipients based upon known allergies to compounds of a similar class such as salicylates, fish oil, eicosapentaenoic acid, or DHA
  • History or presence of hypersensitivity to midazolam, deflazacort, or related compounds (e.g., steroids or their formulation including lactose).
  • Participation in another clinical study within 30 days prior to the first dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment A
2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.
Drug: Midazolam 2 MG/ML
2 mg/ml syrup
Drug: Deflazacort 36Mg Tab
36 mg tablets
EXPERIMENTAL: Treatment B
2000 mg edasalonexent TID on Day 1 to Day 11 with 2 mg midazolam on Day 10 and with 36 mg deflazacort on Day 11.
Drug: Midazolam 2 MG/ML
2 mg/ml syrup
Drug: Deflazacort 36Mg Tab
36 mg tablets
Drug: Edasalonexent 2000 mg TID
CAT-1004 capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of edasalonexent with midazolam and deflazacort
Time Frame: 12 Days
12 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
QTc interval with edasalonexent
Time Frame: 12 Days
12 Days
Number of participants with reported treatment-related adverse events
Time Frame: 12 days
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catabasis Pharmaceuticals

Investigators

  • Study Chair: Joanne Donovan, MD, PhD, Chief Medical Officer, Catabasis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 8, 2020

Primary Completion (ACTUAL)

September 6, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (ACTUAL)

September 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-1004-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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