AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM) - Open label study of REN001 in PMM subjects

Reneo Pharma Ltd.0 个研究点目标入组 80 人开始时间: 2021年11月19日最近更新: 2024年3月18日

适应症

试验速览

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•1. Completed treatment in the parent (STRIDE) study or was participating in Study REN001-101 when the study was stopped due to the COVID-19 pandemic, and in the opinion of the Investigator and the Sponsor have been compliant with the study requirements.
•2. Have PMM which continues to be primarily characterized by exercise intolerance or active muscle pain.
•3. Willing and able to swallow gelatin capsules.
•4. Concomitant medications (including supplements) intended for the treatment of PMM or other co-morbidities likely to remain stable throughout participation in the study where clinically possible.
•5. Signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
•6. Females should be either of non-child-bearing potential or must agree to use highly effective methods of contraception from baseline through to approximately 30 days after last dose of study drug. Males with partners who are WOCBP must also use contraception from baseline through to 14 weeks after last dose of study drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Anticipated to need a PPAR agonist other than REN001 during the study.
•2. Anticipated to need drugs during the study with a narrow therapeutic index and Breast Cancer Resistant Protein (BCRP) mediated absorption, distribution, metabolism and excretion (ADME).
•3. Intent to donate blood, or blood components during the study or within one month after completion of the study.
•4. Current drug dependency. Use of opiates/cannabis for medical reasons is acceptable with prescription evidence or at the Investigator’s discretion.
•5. Current alcohol dependency.
•6. Any medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results and, in the judgment of the Investigator and Medical Monitor, would make the subject inappropriate for entry into this study.
•7. Pregnant or nursing females.

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