Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543370
• Other study ID #: CAT-1004-106
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 1, 2020
• Est. primary completion date: September 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Celerion Clinical Research Unit	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Catabasis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of edasalonexent with midazolam and deflazacort		12 Days
Secondary	QTc interval with edasalonexent		12 Days
Secondary	Number of participants with reported treatment-related adverse events		12 days