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Trial record 3 of 8 for:    cat-1004

Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04543370
Recruitment Status : Active, not recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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.

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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
Estimated Primary Completion Date : September 6, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543370


Locations
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United States, Arizona
Celerion Clinical Research Unit
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Catabasis Pharmaceuticals
Investigators
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Study Chair: Joanne Donovan, MD, PhD Chief Medical Officer, Catabasis
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Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04543370    
Other Study ID Numbers: CAT-1004-106
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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