COVID-19Phase 1NCT05594615
Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
A Phase 1 study testing EDP-235, Midazolam and Rosuvastatin in people with COVID-19, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- EDP-235, Midazolam and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 18 Nov 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An informed consent document signed and dated by the subject
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
- Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
- Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
Who cannot join
- Clinically relevant evidence or history of illness or disease
- Pregnant or nursing females
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
- A positive urine drug screen at Screening or Day -1
- Current tobacco smokers or use of tobacco within 3 months prior to Screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
Show all 9Show fewer
- History of regular alcohol consumption
- Participation in a clinical trial within 30 days prior to the first dose of study drug
- History of drug allergy to midazolam, caffeine, or rosuvastatin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
- Conditions
- COVID-19
- Being tested
- EDP-235, Midazolam, Rosuvastatin, Caffeine
- Keywords
- drug-drug interaction
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-235Drug
Subjects will receive EDP-235 once daily on Days 5-15
MidazolamDrug
Subjects will receive midazolam once daily on Days 1 and 12
RosuvastatinDrug
Subjects will receive rosuvastatin once daily on Days 2 and 13
CaffeineDrug
Subjects will receive caffeine once daily on Days 1 and 12
| Study group | Role | What they receive |
|---|---|---|
| EDP-235, midazolam, rosuvastatin and caffeine | Experimental | Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days Receives: Drug: EDP-235; Drug: Midazolam; Drug: Rosuvastatin; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
Measured: Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
Measured: Up to 17 Days
Secondary outcomes (1)
Safety measured by adverse events
Measured: Up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start6 Oct 2022
- Primary completion4 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594615
- Sponsor's protocol ID
- EDP 235-003
- Status last verified
- Apr 2023
- First submitted
- 21 Oct 2022
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT05594615
- Acronym / sponsor ID
- EDP 235-003
- Conditions
- COVID-19
- Keywords
- drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 26 Oct 2022 (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.
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDP-235, midazolam, rosuvastatin and caffeine | Experimental | Drug: EDP-235, Drug: Midazolam, Drug: Rosuvastatin, Drug: CaffeineSubjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- An informed consent document signed and dated by the subject
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
- Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
- Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
Key exclusion criteria (9 listed)
- Clinically relevant evidence or history of illness or disease
- Pregnant or nursing females
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
- A positive urine drug screen at Screening or Day -1
- Current tobacco smokers or use of tobacco within 3 months prior to Screening.
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 |
|---|---|---|
| EDP-235Subjects will receive EDP-235 once daily on Days 5-15 | Drug | EDP-235, midazolam, rosuvastatin and caffeine |
| MidazolamSubjects will receive midazolam once daily on Days 1 and 12 | Drug | EDP-235, midazolam, rosuvastatin and caffeine |
| RosuvastatinSubjects will receive rosuvastatin once daily on Days 2 and 13 | Drug | EDP-235, midazolam, rosuvastatin and caffeine |
| CaffeineSubjects will receive caffeine once daily on Days 1 and 12 | Drug | EDP-235, midazolam, rosuvastatin and caffeine |
Primary outcome
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
Time frame: Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235
Time frame: Up to 17 Days
1 secondary outcome
Safety measured by adverse events
Time frame: Up to 22 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 27 Apr 2023.
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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.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
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 EDP-235, Midazolam and Rosuvastatin in people with COVID-19, run by Enanta Pharmaceuticals, Inc 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 4 inclusion and 9 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 27 Apr 2023. 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?
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 (time frame: Up to 17 Days). The study lists 2 primary outcomes in all. 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 27 Apr 2023.