Last reviewed · How we verify
NCT02298920
A Phase I, Open-Label Study to Assess the Absorption, Metabolism, Excretion, Safety and Tolerability of a Single Oral Dose of Radiolabeled [14C]-AZD0914 in Healthy Male Subjects
Completed
Phase 1
Last updated 1 June 2015
What this trial tests
Phase 1 trial testing AZD0914 in Healthy in 6 participants. Completed in 1 February 2015.
Timeline
1 January 2015
Primary endpoint
1 February 2015
1 February 2015
1 February 2015
Quick facts
| Lead sponsor | Entasis Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 6 |
| Start date | 1 January 2015 |
| Primary completion | 1 February 2015 |
| Estimated completion | 1 February 2015 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- AZD0914 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Entasis Therapeutics — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
PK Parameters
Time frame: Up to 11 days
Maximum observed concentration (Cmax), time to maximum observed concentration (tmax), area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-t), area under the concentration-time curve extrapolated to infinity (AUC0-inf), apparent terminal elimination rate constant (lambdaZ), apparent terminal elimination half-life (t1/2), apparent clearance (Cl/F) (oral and -
Urine and Feces PK Parameters
Time frame: Up to 11 days
The following pharmacokinetic parameters will be calculated, whenever possible, based on the urine total radioactivity concentrations: amount excreted in urine (Aeu) over the sampling interval, renal clearance (CLR), and the percent excreted in urine (%Feu). For fecal total radioactivity concentrations, the following pharmacokinetic parameters will be calculated for \[14C\] AZD0914 derived radioac -
Metabolites
Time frame: Up to 11 days
Metabolites of \[14C\]-AZD0914 will be identified. Pharmacokinetic parameters for the metabolites of \[14C\]-AZD0914 will be calculated, as deemed appropriate, based on plasma and urine concentration levels. Data may be presented in a separate report.
Sponsor's own description
This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Single-Dose Pharmacokinetics, Excretion, and Metabolism of Zoliflodacin, a Novel Spiropyrimidinetrione Antibiotic, in Healthy Volunteers.
O'Donnell J, Lawrence K, Vishwanathan K, Hosagrahara V, et al · · 2019 · cited 18× · PMID 30373802 · DOI 10.1128/aac.01808-18
Verify or expand the search:
- PubMed search for NCT02298920
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AZD0914
Trials testing the same drug.
- NCT03613649 — Thorough QT/QTC (TQT) Clinical Trial to Evaluate the Effect of Zoliflodacin on Cardiac Repolarization in Healthy Male an · Phase 1 · completed
- NCT03404167 — A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin in Healthy Male and Fem · Phase 1 · completed
- NCT02257918 — Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea · Phase 2 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Entasis Therapeutics trials
Trials by the same sponsor.
- NCT03894046 — Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections · Phase 3 · completed
- NCT04018950 — Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects · Phase 1 · completed
- NCT03985410 — Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers · Phase 1 · completed
- NCT03491748 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Su · Phase 1 · completed
- NCT03445195 — Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complica · 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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02298920 (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 Entasis Therapeutics
- Last refreshed: 1 June 2015
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/NCT02298920.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing