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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04226274
Other study ID # REN001-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 10, 2019
Est. completion date October 11, 2021

Study information

Verified date January 2022
Source Reneo Pharma Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess REN001 safety in subjects with McArdle Disease


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 11, 2021
Est. primary completion date October 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects must give written, signed and dated informed consent - Confirmed diagnosis of McArdle Disease - Subjects must be able to remain on stable medication through the study and specifically must not commence or have changes to agents that affect metabolism such as medication for diabetes - Follow a stable dietary regimen as documented by a 3-day dietary record obtained during the screening period. Exclusion Criteria: - Documented history of ongoing rhabdomyolysis - Evidence of acute crisis from their underlying disease - Currently following or planning to start a ketogenic diet - Treatment with an investigational drug within 1 month or within 5 half-lives, whichever is longer - Have been hospitalized within the 3 months prior to screening for any major medical condition - Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator in discussion with the Medical Monitor, would make the subject inappropriate for entry into this study - Pregnant or nursing females

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
REN001
Once daily for 12 weeks

Locations

Country Name City State
Spain Instituto de Investigación Hospital 12 de Octubre Madrid
United Kingdom National Hospital for Neurology and Neurosurgery, Queens Square London

Sponsors (1)

Lead Sponsor Collaborator
Reneo Pharma Ltd

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Number of participants with Adverse Events (AEs) as a measure of safety and tolerability up to Week 12
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