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NCT04092725
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
Phase 1 trial testing DAB in Pharmacokinetics in 36 participants. Completed in 3 January 2020.
3 January 2020
Quick facts
| Lead sponsor | Scynexis, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 9 September 2019 |
| Primary completion | 3 January 2020 |
| Estimated completion | 3 January 2020 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- DAB — full drug profile →
- SCY-078 plus DAB — full drug profile →
Conditions studied
- Pharmacokinetics — all drugs for Pharmacokinetics →
Sponsor
Scynexis, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1 open-label, randomized, two-period, crossover study to evaluate the effect of repeated oral doses of SCY-078 (Ibrexafungerp) on the pharmacokinetics of dabigatran administered orally to healthy subjects.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Novel antifungals and treatment approaches to tackle resistance and improve outcomes of invasive fungal disease.
Hoenigl M, Arastehfar A, Arendrup MC, Brüggemann R, et al · · 2024 · cited 86× · PMID 38602408 · DOI 10.1128/cmr.00074-23 -
Ibrexafungerp: A First-in-Class Oral Triterpenoid Glucan Synthase Inhibitor.
Jallow S, Govender NP. · · 2021 · cited 86× · PMID 33668824 · DOI 10.3390/jof7030163 -
Antifungal resistance, combinations and pipeline: oh my!
Stover KR, Hawkins BK, Keck JM, Barber KE, et al · · 2023 · cited 10× · PMID 38021410 · DOI 10.7573/dic.2023-7-1 -
Ibrexafungerp: Mechanism of Action, Clinical, and Translational Science.
Walley AH, Dupuis LN, Woodahl EL, Killam SR. · · 2025 · cited 2× · PMID 40970688 · DOI 10.1111/cts.70362
Verify or expand the search:
- PubMed search for NCT04092725
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Scynexis, Inc. trials
Trials by the same sponsor.
- NCT06954493 — Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp · Phase 1 · completed
- NCT05668429 — ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects · Phase 1 · completed
- NCT05178862 — A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed b · Phase 3 · terminated
- NCT05908682 — Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes · recruiting
- NCT05399641 — Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis · Phase 3 · 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 NCT04092725 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Scynexis, Inc.
- Last refreshed: 2 September 2020
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/NCT04092725.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing