Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Edasalonexent 2000 mg TID; Drug: Midazolam 2 MG/ML; Drug: Deflazacort 36Mg Tab

• Registration Number: NCT04543370
• Lead Sponsor: Catabasis Pharmaceuticals

Brief 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.

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 Timeline

• Study Start: 2020-08-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-09-03
• Primary Completion: 2020-09-06
• Study First Posted: 2020-09-10
• Study Completion: 2020-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment B	Midazolam 2 MG/ML	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.
Treatment B	Edasalonexent 2000 mg TID	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.
Treatment A	Deflazacort 36Mg Tab	2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.
Treatment A	Midazolam 2 MG/ML	2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.
Treatment B	Deflazacort 36Mg Tab	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.

Primary Outcome Measures

Name	Time	Method
AUC of edasalonexent with midazolam and deflazacort	12 Days

Secondary Outcome Measures

Name	Time	Method
QTc interval with edasalonexent	12 Days
Number of participants with reported treatment-related adverse events	12 days

Trial Locations

Locations (1)

Celerion Clinical Research Unit; 🇺🇸 Tempe, Arizona, United States