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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

Completed Phase 1 Last updated 14 April 2014
What this trial tests

Phase 1 trial testing Part A in Gonococcal (GC) Infection in 100 participants. Completed in 1 March 2014.

Timeline
1 September 2013
Primary endpoint
1 March 2014
1 March 2014

Quick facts

Lead sponsorAstraZeneca
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment100
Start date1 September 2013
Primary completion1 March 2014
Estimated completion1 March 2014
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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.

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):

  1. Preparing for an era of untreatable gonorrhea.
    Barbee LA. · · 2014 · cited 38× · PMID 24685549 · DOI 10.1097/qco.0000000000000058
  2. 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
  3. 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
  4. 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:

Other trials of Part A

Trials testing the same drug.

Other recruiting trials for Gonococcal (GC) Infection

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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