HealthyPhase 1NCT04543370
Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects
A Phase 1 study testing Edasalonexent 2000 mg TID, Midazolam 2 MG/ML and Deflazacort 36Mg Tab in people with Healthy, run by Catabasis Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Edasalonexent 2000 mg TID, Midazolam 2 MG/ML and Deflazacort 36Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2020to 1 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion Clinical Research Unit
Tempe, Arizona, 85283
About this study
Official title: A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Edasalonexent 2000 mg TID, Midazolam 2 MG/ML, Deflazacort 36Mg Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edasalonexent 2000 mg TIDDrug
CAT-1004 capsules
Midazolam 2 MG/MLDrug
2 mg/ml syrup
Deflazacort 36Mg TabDrug
36 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2. Receives: 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. Receives: Drug: Edasalonexent 2000 mg TID; Drug: Midazolam 2 MG/ML; Drug: Deflazacort 36Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of edasalonexent with midazolam and deflazacort
Measured: 12 Days
Secondary outcomes (2)
QTc interval with edasalonexent
Measured: 12 Days
Number of participants with reported treatment-related adverse events
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start8 Aug 2020
- Primary completion6 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catabasis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Donovan, MD, PhD, Study chair, Chief Medical Officer, Catabasis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543370
- Sponsor's protocol ID
- CAT-1004-106
- Status last verified
- Jan 2021
- First submitted
- 21 Aug 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04543370
- Acronym / sponsor ID
- CAT-1004-106
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 6 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Midazolam 2 MG/ML, Drug: Deflazacort 36Mg Tab2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2. |
| Treatment B | Experimental | Drug: Edasalonexent 2000 mg TID, Drug: Midazolam 2 MG/ML, Drug: Deflazacort 36Mg Tab2000 mg edasalonexent TID on Day 1 to Day 11 with 2 mg midazolam on Day 10 and with 36 mg deflazacort on Day 11. |
Who may qualify
- Ages
- 18 to 55 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edasalonexent 2000 mg TIDCAT-1004 capsules | Drug | Treatment B |
| Midazolam 2 MG/ML2 mg/ml syrup | Drug | Treatment A, Treatment B |
| Deflazacort 36Mg Tab36 mg tablets | Drug | Treatment A, Treatment B |
Primary outcome
AUC of edasalonexent with midazolam and deflazacort
Time frame: 12 Days
2 secondary outcomes
QTc interval with edasalonexent
Time frame: 12 Days
Number of participants with reported treatment-related adverse events
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Donovan, MD, PhD study chair
Chief Medical Officer, Catabasis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Edasalonexent 2000 mg TID, Midazolam 2 MG/ML and Deflazacort 36Mg Tab in people with Healthy, run by Catabasis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of edasalonexent with midazolam and deflazacort (time frame: 12 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.