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NCT04871724
Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects
Phase 1 trial testing EDP-938 in RSV Infection in 24 participants. Completed in 16 April 2021.
30 March 2021
Quick facts
| Lead sponsor | Enanta Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 12 March 2021 |
| Primary completion | 30 March 2021 |
| Estimated completion | 16 April 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- EDP-938 — full drug profile →
- Fluconazole (fluconazole) — full drug profile →
Conditions studied
- RSV Infection — all drugs for RSV Infection →
Sponsor
Enanta Pharmaceuticals, Inc — full company profile →
Who can join
Adults 18 to 55, any sex, with RSV Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04871724
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EDP-938
Trials testing the same drug.
- NCT05568706 — A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. · Phase 2 · completed
- NCT04816721 — A Study to Evaluate EDP 938 Regimens in Children With RSV · Phase 2 · completed
- NCT04633187 — Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Re · Phase 2 · terminated
- NCT04927793 — Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects · Phase 1 · completed
- NCT04498741 — Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects · Phase 1 · completed
Other recruiting trials for RSV Infection
Currently open trials in the same condition.
- NCT06881953 — Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France · recruiting
- NCT06866405 — A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Sin · Phase 3 · recruiting
- NCT06843317 — Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults · Phase 1 · recruiting
- NCT06172660 — Real-World Effectiveness of Perinatal RSV Immunoprophylaxis · recruiting
- NCT06640387 — CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools · recruiting
Other Enanta Pharmaceuticals, Inc trials
Trials by the same sponsor.
- NCT06917508 — A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participa · Phase 1 · completed
- NCT06847464 — A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the P · Phase 1 · completed
- NCT06601192 — A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults · Phase 1 · completed
- NCT06170242 — A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus · Phase 2 · completed
- NCT05568706 — A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04871724 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Enanta Pharmaceuticals, Inc
- Last refreshed: 4 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04871724.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing