The primary purpose of this study is to evaluate the safety and tolerability profile of S-606001 in participants with LOPD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
S-606001 will be administered orally as a tablet.
Number of Participants with Treatment-emergent Adverse Events
Time frame: Baseline (Day 1) through Week 49
Change From Baseline in Percent Forced Vital Capacity (%FVC)
Time frame: Baseline (Day 1), Week 48
Change From Baseline in Maximum Expiratory Capacity (MEP)
Time frame: Baseline (Day 1), Week 48
Change From Baseline in Minimum Inspiratory Capacity (MIP)
Time frame: Baseline (Day 1), Week 48
Change From Baseline in 6-minute Walk Test (6MWT)
Time frame: Baseline (Day 1), Week 48
Change From Baseline in Gait, Stair, Gower's Maneuver, and Chair (GSGC) Score
Time frame: Baseline (Day 1), Week 48
Change from Baseline in Daily Living Activity Levels as Assessed by the Investigator
Time frame: Baseline (2-4 weeks prior to Day 1), Week 48
Plasma Concentration of S-606001 and Metabolites
Time frame: Up to Week 28
Shionogi Clinical Trials Administrator Clinical Support Help Line
CONTACT
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