Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women

NCT01989949 ↗

Phase 1 Completed 20 enrolled Tetraphase Pharmaceuticals, Inc Department of Health and Human Services · collab

NaSingle-groupOpen-labelBasic science

Summary

This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.

Timeline

Start: 2012-11
Primary completion: 2013-01
Completion: 2013-04

Publications

Ji X-w, Mak WY, Xue F, Yang W-y, Kuan IH-S, Xiang X-q, Li Y, Zhu X. Population pharmacokinetics and pulmonary modeling of eravacycline and the determination of microbiological breakpoint and cutoff of PK/PD. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0106524. doi: 10.1128/aac.01065-24. Epub 2025 Jan 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eravacycline	Small molecule	1 mg/kg	Intravenous

Indications

No indication recorded.