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NCT03792971
Study to Evaluate the Effects of 90 mg Intravenous Infusions of GC4419 on the Single Dose Pharmacokinetics of Dextromethorphan in Healthy Adult Subjects
Phase 1 trial testing Dextromethorphan HBr in Healthy in 13 participants. Completed in 15 February 2019.
15 February 2019
Quick facts
| Lead sponsor | Galera Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 10 February 2019 |
| Primary completion | 15 February 2019 |
| Estimated completion | 15 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dextromethorphan HBr — full drug profile →
- GC4419 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Galera Therapeutics, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This will be a single center, phase 1, open-label, fixed-sequence study under fasting conditions to evaluate the effect of 90 mg intravenous (IV) infusions of GC4419 on the single-dose pharmacokinetic (PK) of dextromethorphan (DM) capsules liquid filled.
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 NCT03792971
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Galera Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT04698915 — Phase 2b Study of GC4711 in Combination With SBRT for Nonmetastatic Pancreatic Cancer · Phase 2 · terminated
- NCT04476797 — Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC · Phase 1, PHASE2 · terminated
- NCT04555096 — A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 · Phase 2 · terminated
- NCT04529850 — Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer · Phase 2 · completed
- NCT04225026 — Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer · Phase 2 · terminated
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 NCT03792971 (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 Galera Therapeutics, Inc.
- Last refreshed: 19 June 2019
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/NCT03792971.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing