Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT04543370
• Recruitment Status: Completed
• First Posted: September 10, 2020
• Last Update Posted: January 28, 2021
• Sponsor: Catabasis Pharmaceuticals
• Information provided by (Responsible Party): Catabasis Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Edasalonexent 2000 mg TID; Drug: Midazolam 2 MG/ML; Drug: Deflazacort 36Mg Tab	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects
• Actual Study Start Date: August 8, 2020
• Actual Primary Completion Date: September 6, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

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: Edasalonexent 2000 mg TID; CAT-1004 capsules; Drug: Midazolam 2 MG/ML; 2 mg/ml syrup; Drug: Deflazacort 36Mg Tab; 36 mg tablets

Outcome Measures

Primary Outcome Measures :

1. AUC of edasalonexent with midazolam and deflazacort [ Time Frame: 12 Days ]

Secondary Outcome Measures :

1. QTc interval with edasalonexent [ Time Frame: 12 Days ]
2. Number of participants with reported treatment-related adverse events [ Time Frame: 12 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Celerion Clinical Research Unit

Tempe, Arizona, United States, 85283

Sponsors and Collaborators

Catabasis Pharmaceuticals

Investigators

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

More Information

• Responsible Party: Catabasis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04543370
• Other Study ID Numbers: CAT-1004-106
• First Posted: September 10, 2020
• Last Update Posted: January 28, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Deflazacort; Midazolam; Adjuvants, Anesthesia; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors