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A First in Human Study of RT001 in Patients With Friedreich's Ataxia

NCT02445794 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-11-27

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of RT001 in patients with Friedreich's ataxia.

Conditions

Interventions

DRUG

Low dose cohort

RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.

DRUG

High dose cohort

RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.

Sponsors & Collaborators

  • Biojiva LLC

    lead INDUSTRY

Principal Investigators

  • Curtis Scribner, MD · Biojiva LLC

  • Theresa Zesiewicz, MD · USF Ataxia Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-06-30
Completion
2016-07-31

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 NCT02445794 on ClinicalTrials.gov