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NCT01929629
A Phase I, Randomized, Placebo-controlled, Single-center Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0914 After a Single Oral Administration and to Assess the Effect of Food in Healthy Adult Volunteers
Phase 1 trial testing Part A in Gonococcal (GC) Infection in 100 participants. Completed in 1 March 2014.
1 March 2014
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 100 |
| Start date | 1 September 2013 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 March 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Gonococcal (GC) Infection — all drugs for Gonococcal (GC) Infection →
Sponsor
AstraZeneca — full company profile →
Who can join
Adults 18 to 55, any sex, with Gonococcal (GC) Infection. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Description of the safety profile in terms of adverse events; blood pressure, heart rate and body temperature; electrocardiograms; telemetry; clinical chemistry ; haematology and physical examination
Time frame: From admission on day -1 until follow up. ( Max 16 days)
Applies to Part A and B
Sponsor's own description
The purpose of this study is to assess the safety and tolerability of orally administered AZD0914 in healthy adult subjects.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Preparing for an era of untreatable gonorrhea.
Barbee LA. · · 2014 · cited 38× · PMID 24685549 · DOI 10.1097/qco.0000000000000058 -
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 -
Antimicrobial Resistance in Neisseria gonorrhoeae: Proceedings of the STAR Sexually Transmitted Infection-Clinical Trial Group Programmatic Meeting.
Cristillo AD, Bristow CC, Torrone E, Dillon JA, et al · · 2019 · cited 15× · PMID 30363025 · DOI 10.1097/olq.0000000000000929 -
Thorough QT Study To Evaluate the Effect of Zoliflodacin, a Novel Therapeutic for Gonorrhea, on Cardiac Repolarization in Healthy Adults.
Newman LM, Kankam M, Nakamura A, Conrad T, et al · · 2021 · cited 7× · PMID 34606332 · DOI 10.1128/aac.01292-21
Verify or expand the search:
- PubMed search for NCT01929629
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Part A
Trials testing the same drug.
- NCT05082051 — Oral CDX-7108 in Healthy Adults and EPI Subjects · Phase 1 · completed
- NCT04510649 — Surufatinib DDI With a PPI and a CYP3A Inducer · Phase 1 · completed
- NCT03474640 — Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies · Phase 1 · completed
Other recruiting trials for Gonococcal (GC) Infection
Currently open trials in the same condition.
- NCT06897943 — Epidemiology of Gonococcal Arthritis (EpGAr) · recruiting
Other AstraZeneca trials
Trials by the same sponsor.
- NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
- NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
- NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
- NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
- NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting
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 NCT01929629 (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 AstraZeneca
- Last refreshed: 14 April 2014
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/NCT01929629.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing