A Phase 1 TP-271 Oral PK Single Ascending Dose Study

Bacterial Infections Clinical Trial

Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TP-271 in Healthy Adult Subjects, Including 1 Cross-over Arm

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of up to 6 different single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or female subjects.

Clinical Trial Description

This study is designed to assess oral TP-271, and the objectives of the study are to examine the safety, tolerability, and PK of oral TP-271 in healthy adult subjects after administration of a single dose. A single-dose, dose-escalating study design is common for early clinical studies. A cohort size of 8 subjects (6 receiving oral TP-271 and 2 receiving placebo) for the single ascending dose cohorts (Cohorts A through F) will allow sufficient data assessments of plasma and urine concentrations, plasma PK parameters, and safety without exposing large numbers of subjects to oral TP-271 in this clinical study. One additional cohort of 8 subjects will first receive treatment with TP-271 or TP-271 co-administered with ethylenediaminetetraacetic acid (EDTA) and then cross-over to treatment with the other study agent, which will allow a comparison of the bioavailability of TP-271 alone compared to TP-271 co-administered with EDTA, as well as allow additional assessment of plasma and urine concentrations, plasma PK parameters, and safety. ;

Related Conditions & MeSH terms

• Bacterial Infections

• NCT number: NCT03024034
• Study type: Interventional
• Source: La Jolla Pharmaceutical Company
• Status: Completed
• Phase: Phase 1
• Start date: March 2, 2017
• Completion date: June 4, 2018