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

NCT03450187 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-12-17

No results posted yet for this study

Summary

This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects. Male or female subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.

Conditions

Interventions

DRUG

TP-271

multiple oral doses of TP-271 or placebo, randomized 6:2, doses escalating 50 mg, 100 mg, 200 mg, 300 mg, 400 mg once daily for 7 days.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Tetraphase Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Larry Tsai, MD · Tetraphase Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2018-12-31
Completion
2019-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450187 on ClinicalTrials.gov