A Phase 1b Study of the Safety of REN001 in Patients With Fatty Acid Oxidation Disorders (NCT03833128) | Clinical Trial Compass
CompletedPhase 1
A Phase 1b Study of the Safety of REN001 in Patients With Fatty Acid Oxidation Disorders
United States24 participantsStarted 2019-04-04
Plain-language summary
The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Subjects must give written, signed and dated informed consent
Confirmed diagnosis of FAOD
A diagnostic acylcarnitine profile, in blood or cultured fibroblasts
A stable treatment regimen for at least 30 days prior to enrollment
Exclusion Criteria:
Unstable or poorly controlled disease
Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer
Have been hospitalized within 3 months prior to screening for any major medical event
Pregnant or nursing females