drugset / Trial / NCT03775668

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

NCT03775668

Phase 1 Completed 8 enrolled Allecra
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-11-27
Primary completion
2018-12-05
Completion
2019-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject enmetazobactam Small molecule 500 mg Intravenous

Indications

No indication recorded.