Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

NCT04543370 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CAT-1004-106
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC of edasalonexent with midazolam and deflazacort

  12 Days

Secondary Outcomes (2)

• QTc interval with edasalonexent

  12 Days

• Number of participants with reported treatment-related adverse events

  12 days

Study Arms (2)

Treatment A

EXPERIMENTAL

2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.

Drug: Midazolam 2 MG/ML; Drug: Deflazacort 36Mg Tab

Treatment B

EXPERIMENTAL

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; Drug: Midazolam 2 MG/ML; Drug: Deflazacort 36Mg Tab

Interventions

Edasalonexent 2000 mg TID DRUG

CAT-1004 capsules

Treatment B

Midazolam 2 MG/ML DRUG

2 mg/ml syrup

Treatment A; Treatment B

Deflazacort 36Mg Tab DRUG

36 mg tablets

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catabasis Pharmaceuticals: lead

Study Sites (1)

Celerion Clinical Research Unit

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

edasalonexent; Midazolam; deflazacort

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joanne Donovan, MD, PhD

  Chief Medical Officer, Catabasis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 10, 2020
• Study Start: August 8, 2020
• Primary Completion: September 6, 2020
• Study Completion: October 1, 2020
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)