NCT03024034

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	TP-271	single oral dose of TP 271 or placebo, randomized 3:1, doses escalating as 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg, and a final crossover cohort of 50 mg TP-271 and 50 mg TP-271 with 250 mg of EDTA, or placebo and 250 mg of EDTA

Timeline

• Start date: 2017-03-02
• Primary completion: 2017-12-01
• Completion: 2018-06-04
• First posted: 2017-01-18
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study