Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Formerly High Point Pharmaceuticals, LLC, North Carolina, USA
Research Article
A Phase 1 Randomized, Placebo-Controlled, Parallel Study of the Novel Peroxisome Proliferator-Activated Receptor ? Agonist REN001 in Healthy Volunteers during and After Limb Immobilization
Author(s): Madhu Davies*, Alejandro Dorenbaum, Shulin Wang and Bettina Mittendorfer
Objective: Assess the safety, tolerability and effects of the Peroxisome Proliferator-Activated Receptor δ (PPARδ) agonist REN001 on muscle recovery after limb immobilization.
Methods: Eligible healthy adults were randomly assigned 1:1 to REN001 100 mg twice daily or placebo for 28 days. Participants were leg-immobilized with a knee brace and used crutches from 1 to 14 days. Changes in muscle strength, gene expression from muscle biopsies and muscle Cross-Sectional Area (CSA) in the immobilized leg were evaluated. After 14 days of dosing the brace was removed and the subjects took study drug for another 14 days, gradually resuming regular physical activity. The primary pharmacodynamics endpoint was the change from baseline to day 21 in muscle strength as measured by knee extension.
Results: Twenty-four .. View More»
DOI:
10.35248/2167-0870.22.12.495