NCT03775668 is a Phase 1 clinical trial of 1 µCi of 14C-AAI101 + 500 mg AAI101 in Healthy, sponsored by Allecra.

Who is sponsoring NCT03775668?

NCT03775668 is sponsored by Allecra.

What drugs are being tested in NCT03775668?

Interventions in NCT03775668: 1 µCi of 14C-AAI101 + 500 mg AAI101.

Is NCT03775668 still recruiting?

NCT03775668 is currently completed. Last updated 26 February 2019.

Last reviewed 2019-02-26 · How we verify

NCT03775668

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single Dose Mass Balance Study With C14 - Labeled AAI101 in Healthy Male Volunteers

Completed Phase 1 Last updated 26 February 2019

What this trial tests

Phase 1 trial testing 1 µCi of 14C-AAI101 + 500 mg AAI101 in Healthy in 8 participants. Completed in 31 January 2019.

Timeline

27 November 2018

Primary endpoint
5 December 2018

31 January 2019

Quick facts

Lead sponsor	Allecra
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	27 November 2018
Primary completion	5 December 2018
Estimated completion	31 January 2019
Sites	1 location across United States

Drugs / interventions tested

1 µCi of 14C-AAI101 + 500 mg AAI101 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Allecra — full company profile →

Who can join

Adults 18 to 65, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, single dose, pharmacokinetic (PK) study conducted at 1 study center in the United States (USA). This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered 14C-AAI101.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

New Carbapenemase Inhibitors: Clearing the Way for the β-Lactams.
Vázquez-Ucha JC, Arca-Suárez J, Bou G, Beceiro A. · · 2020 · cited 87× · PMID 33291334 · DOI 10.3390/ijms21239308
Resistance of Gram-Negative Bacteria to Cefepime-Enmetazobactam: A Systematic Review.
Falagas ME, Romanos LT, Kontogiannis DS, Tsiara K, et al · · 2025 · cited 2× · PMID 40872287 · DOI 10.3390/pathogens14080777
Cefepime and New Cefepime/Beta-Lactamase Inhibitor Combination for the Treatment of Gram-Negative Bacteria: Chemical Structure and Mechanism of Action, Microbiological Target, Clinical Use and PK/PD Characteristics
Carcione D, Brigante G, Carducci A, Intra J, et al · · 2026

Verify or expand the search:

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Other Allecra trials

Trials by the same sponsor.

NCT05826990 — A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI · Phase 2 · unknown
NCT03687255 — Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections · Phase 3 · completed
NCT03680612 — Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI · Phase 2 · completed
NCT03680352 — Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects · Phase 1 · completed
NCT03680378 — Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF) · Phase 1 · 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 NCT03775668 (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 Allecra
Last refreshed: 26 February 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/NCT03775668.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing