RSV InfectionPhase 1NCT04498741
Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
A Phase 1 study testing EDP-938, Tacrolimus and Dabigatran in people with RSV Infection, run by Enanta Pharmaceuticals, Inc at 1 site in United States.
Trial summary
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection
- What is being tested?
- EDP-938, Tacrolimus and Dabigatran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2020to 1 Jun 2021
- 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 938.
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).
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- History of regular alcohol consumption.
- Participation in a clinical trial within 30 days prior to the first dose of study drug.
- For Part 1 subjects:
- Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus
- For Part 2 Subjects:
- Clinical history or evidence at screening of medically significant bleeding
- History of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (SLE), or recurrent spontaneous abortions
- A platelet count <LLN, or INR >ULN, or aPTT > ULN at Screening
- Ongoing daily use of nonsteroidal anti-inflammatory drugs
- For Part 3 subjects:
- AST and/or ALT >ULN at Screening
- For Part 4 subjects:
- History of glaucoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, 66219
About this study
Official title: A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
- Conditions
- RSV Infection
- Being tested
- EDP-938, Tacrolimus, Dabigatran, Rosuvastatin, Midazolam
- Keywords
- drug-drug interaction
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-938Drug
Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)
EDP-938Drug
Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)
EDP-938Drug
Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)
TacrolimusDrug
Subjects will receive tacrolimus once daily on Day 1 and Day 24
DabigatranDrug
Subjects will receive dabigatran once daily on Day 1 and Day 13
RosuvastatinDrug
Subjects will receive rosuvastatin once daily on Day 1 and Day 13
EDP-938Drug
Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)
MidazolamDrug
Subjects will receive midazolam once daily on Day 1 and Day 16
| Study group | Role | What they receive |
|---|---|---|
| EDP-938 and tacrolimus interaction (Part 1) | Experimental | Not described Receives: Drug: EDP-938; Drug: Tacrolimus |
| EDP-938 and dabigatran interaction (Part 2) | Experimental | Not described Receives: Drug: EDP-938; Drug: Dabigatran |
| EDP-938 and rosuvastatin interaction (Part 3) | Experimental | Not described Receives: Drug: EDP-938; Drug: Rosuvastatin |
| EDP-938 and midazolam interaction (Part 4) | Experimental | Not described Receives: Drug: EDP-938; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of tacrolimus with and without coadministration with EDP-938
Measured: up to 29 days
AUC of tacrolimus with and without coadministration with EDP-938
Measured: up to 29 days
Cmax of dabigatran with and without coadministration with EDP-938
Measured: up to 17 days
AUC of dabigatran with and without coadministration with EDP-938
Measured: up to 17 days
Cmax of rosuvastatin with and without coadministration with EDP-938
Measured: up to 17 days
AUC of rosuvastatin with and without coadministration with EDP-938
Measured: up to 17 days
Cmax of midazolam with and without coadministration with EDP-938
Measured: up to 17 days
AUC of midazolam with and without coadministration with EDP-938
Measured: up to 17 days
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 posted4 Aug 2020
- Study start8 Jul 2020
- Primary completion27 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 4-Part Single Group study
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498741
- Sponsor's protocol ID
- EDP 938-006
- Status last verified
- Aug 2020
- First submitted
- 30 Jul 2020
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Oct 2021. 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 EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04498741
- Acronym / sponsor ID
- EDP 938-006
- Conditions
- RSV Infection
- Keywords
- drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaceutical Research Associates
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 4 Aug 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.
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4-Part Single Group study
| Arm | Type | Receives |
|---|---|---|
| EDP-938 and tacrolimus interaction (Part 1) | Experimental | Drug: EDP-938, Drug: Tacrolimus |
| EDP-938 and dabigatran interaction (Part 2) | Experimental | Drug: EDP-938, Drug: Dabigatran |
| EDP-938 and rosuvastatin interaction (Part 3) | Experimental | Drug: EDP-938, Drug: Rosuvastatin |
| EDP-938 and midazolam interaction (Part 4) | Experimental | Drug: EDP-938, Drug: Midazolam |
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 938.
Key exclusion criteria (19 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-938Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1) | Drug | EDP-938 and tacrolimus interaction (Part 1) |
| EDP-938Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2) | Drug | EDP-938 and dabigatran interaction (Part 2) |
| EDP-938Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3) | Drug | EDP-938 and rosuvastatin interaction (Part 3) |
| TacrolimusSubjects will receive tacrolimus once daily on Day 1 and Day 24 | Drug | EDP-938 and tacrolimus interaction (Part 1) |
| DabigatranSubjects will receive dabigatran once daily on Day 1 and Day 13 | Drug | EDP-938 and dabigatran interaction (Part 2) |
| RosuvastatinSubjects will receive rosuvastatin once daily on Day 1 and Day 13 | Drug | EDP-938 and rosuvastatin interaction (Part 3) |
| EDP-938Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4) | Drug | EDP-938 and midazolam interaction (Part 4) |
| MidazolamSubjects will receive midazolam once daily on Day 1 and Day 16 | Drug | EDP-938 and midazolam interaction (Part 4) |
Primary outcome
Cmax of tacrolimus with and without coadministration with EDP-938
Time frame: up to 29 days
AUC of tacrolimus with and without coadministration with EDP-938
Time frame: up to 29 days
Cmax of dabigatran with and without coadministration with EDP-938
Time frame: up to 17 days
AUC of dabigatran with and without coadministration with EDP-938
Time frame: up to 17 days
Cmax of rosuvastatin with and without coadministration with EDP-938
Time frame: up to 17 days
AUC of rosuvastatin with and without coadministration with EDP-938
Time frame: up to 17 days
Cmax of midazolam with and without coadministration with EDP-938
Time frame: up to 17 days
AUC of midazolam with and without coadministration with EDP-938
Time frame: up to 17 days
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 13 Oct 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.
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-938, Tacrolimus and Dabigatran in people with RSV Infection, 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 19 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 13 Oct 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?
Cmax of tacrolimus with and without coadministration with EDP-938 (time frame: up to 29 days). The study lists 8 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 13 Oct 2021.