COVID-19Phase 1NCT05594602
Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
A Phase 1 study testing EDP-235, Itraconazole and Carbamazepine 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 itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235. 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, Itraconazole and Carbamazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 30 Dec 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 20Show fewer
- History of regular alcohol consumption
- Participation in a clinical trial within 30 days prior to the first dose of study drug
- For Part 2 participants:
- Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens-Johnson Syndrome [SJS and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population
- Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
- For Part 2 and Part 3 participants, the following cardiovascular abnormalities:
- QRS duration >110 ms
- Incomplete right bundle branch block or any complete bundle branch block
- Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
- History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
- Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
- PR interval >220 ms or any 2nd or 3rd degree AV block
- Ventricular pre-excitation
- History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives [e.g. oxcarbazepine]; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A NON-RANDOMIZED, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS
A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
- Conditions
- COVID-19
- Being tested
- EDP-235, Itraconazole, Carbamazepine, Quinidine
- 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 on Days 1 and 14
EDP-235Drug
Subjects will receive EDP-235 on Days 1 and 23
EDP-235Drug
Subjects will receive EDP-235 on Days 1 and 8
ItraconazoleDrug
Subjects will receive itraconazole QD Days 5-18
CarbamazepineDrug
Subjects will receive carbamazepine BID Days 5-23 and Days 24-27
QuinidineDrug
Subjects will receive quinidine BID Days 5-12
| Study group | Role | What they receive |
|---|---|---|
| EDP-235 and Itraconazole interaction (Part 1) | Experimental | Subjects will receive EDP-235 and Itraconazole on respective dosing days Receives: Drug: EDP-235; Drug: Itraconazole |
| EDP-235 and Carbamazepine interaction (Part 2) | Experimental | Subjects will receive EDP-235 and Carbamazepine on respective dosing days Receives: Drug: EDP-235; Drug: Carbamazepine |
| EDP and Quinidine interaction (Part 3) | Experimental | Subjects will receive EDP-235 and Quinidine on respective dosing days Receives: Drug: EDP-235; Drug: Quinidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of EDP-235 with and without coadministration with Itraconazole
Measured: Day 1 through Day 19
AUC of EDP-235 with and without coadministration with Itraconazole
Measured: Day 1 through Day 19
Cmax of EDP-235 with and without coadministration with Carbamazepine
Measured: Day 1 through Day 26
AUC of EDP-235 with and without coadministration with Carbamazepine
Measured: Day 1 through Day 26
Cmax of EDP-235 with and without coadministration with Quinidine
Measured: Day 1 through Day 13
AUC of EDP-235 with and without coadministration with Quinidine
Measured: Day 1 through Day 13
Secondary outcomes (1)
Safety measured by adverse events
Measured: Up to 34 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 completion14 Dec 2022
- Study completion30 Dec 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT05594602
- Sponsor's protocol ID
- EDP 235-002
- 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, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS
- ClinicalTrials.gov ID
- NCT05594602
- Acronym / sponsor ID
- EDP 235-002
- Conditions
- COVID-19
- Keywords
- drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 30 Dec 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 itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDP-235 and Itraconazole interaction (Part 1) | Experimental | Drug: EDP-235, Drug: ItraconazoleSubjects will receive EDP-235 and Itraconazole on respective dosing days |
| EDP-235 and Carbamazepine interaction (Part 2) | Experimental | Drug: EDP-235, Drug: CarbamazepineSubjects will receive EDP-235 and Carbamazepine on respective dosing days |
| EDP and Quinidine interaction (Part 3) | Experimental | Drug: EDP-235, Drug: QuinidineSubjects will receive EDP-235 and Quinidine 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 (20 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 on Days 1 and 14 | Drug | EDP-235 and Itraconazole interaction (Part 1) |
| EDP-235Subjects will receive EDP-235 on Days 1 and 23 | Drug | EDP-235 and Carbamazepine interaction (Part 2) |
| EDP-235Subjects will receive EDP-235 on Days 1 and 8 | Drug | EDP and Quinidine interaction (Part 3) |
| ItraconazoleSubjects will receive itraconazole QD Days 5-18 | Drug | EDP-235 and Itraconazole interaction (Part 1) |
| CarbamazepineSubjects will receive carbamazepine BID Days 5-23 and Days 24-27 | Drug | EDP-235 and Carbamazepine interaction (Part 2) |
| QuinidineSubjects will receive quinidine BID Days 5-12 | Drug | EDP and Quinidine interaction (Part 3) |
Primary outcome
Cmax of EDP-235 with and without coadministration with Itraconazole
Time frame: Day 1 through Day 19
AUC of EDP-235 with and without coadministration with Itraconazole
Time frame: Day 1 through Day 19
Cmax of EDP-235 with and without coadministration with Carbamazepine
Time frame: Day 1 through Day 26
AUC of EDP-235 with and without coadministration with Carbamazepine
Time frame: Day 1 through Day 26
Cmax of EDP-235 with and without coadministration with Quinidine
Time frame: Day 1 through Day 13
AUC of EDP-235 with and without coadministration with Quinidine
Time frame: Day 1 through Day 13
1 secondary outcome
Safety measured by adverse events
Time frame: Up to 34 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, Itraconazole and Carbamazepine 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 20 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 EDP-235 with and without coadministration with Itraconazole (time frame: Day 1 through Day 19). The study lists 6 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.