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Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

NCT04802837 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-08-21

Study results available
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Summary

Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

Conditions

  • Clostridioides Difficile Infection

Interventions

DRUG

Ridinilazole

Ridinilazole 200mg dosed BID for 10 days.

DRUG

Vancomycin

Vancomycin 125mg dosed QID for 10 days.

Sponsors & Collaborators

Principal Investigators

  • Lori Styles, MD · Summit Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2021-09-17
Completion
2022-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT04802837 on ClinicalTrials.gov