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NCT03177278
A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
Phase 1 trial testing [14C]-plazomicin in Healthy Volunteers in 6 participants. Completed in 10 July 2017.
10 July 2017
Quick facts
| Lead sponsor | Achaogen, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 16 June 2017 |
| Primary completion | 10 July 2017 |
| Estimated completion | 10 July 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [14C]-plazomicin — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Achaogen, Inc. — full company profile →
Who can join
Adults 19 to 55, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of \[14C\]-plazomicin in healthy, adult male subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Plazomicin: a new aminoglycoside in the fight against antimicrobial resistance.
Clark JA, Burgess DS. · · 2020 · cited 40× · PMID 32953108 · DOI 10.1177/2049936120952604 -
Plazomicin against Multidrug-Resistant Bacteria: A Scoping Review.
Alfieri A, Di Franco S, Donatiello V, Maffei V, et al · · 2022 · cited 21× · PMID 36556314 · DOI 10.3390/life12121949
Verify or expand the search:
- PubMed search for NCT03177278
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Achaogen, Inc. trials
Trials by the same sponsor.
- NCT03270553 — A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin · Phase 1 · completed
- NCT03163550 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interaction Potential of ACHN-3 · Phase 1 · completed
- NCT02486627 — A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including · Phase 3 · completed
- NCT01970371 — A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae ( · Phase 3 · completed
- NCT01096849 — A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acu · 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 NCT03177278 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Achaogen, Inc.
- Last refreshed: 12 July 2017
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/NCT03177278.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing