A Phase 1, Randomized, Double-Blind, Single Ascending Dose Trial of the Safety, Tolerability and Pharmacokinetics of NPT200-11 in Healthy Subjects

Status: 
Completed
Clinicaltrials.gov identifier: 
NCT02606682
Sponsor: 
Neuropore Therapies/UCB
Enrollment: 
55
Study Design: 
Single ascending dose of orally administered capsule(s) NPT200-11 vs placebo: 15, 30, 60,120, 240, 360 and 480 mg dose.
Rationale: 
PRIMARY OUTCOME MEASURE: Safety, including adverse events, physical examinations, ECGs, clinical laboratory tests. Time Frame: Screening (28 days prior to dosing) through Day 7. SECONDARY OUTCOME MEASURES: To possibly determine the maximally tolerated dose (MTD) of orally administered NPT200-11 in healthy subjects. The number of participants with unacceptable toxicities at each dose level will determine the maximally tolerated dose.
Comments: 
An early phase SAD study was completed but the data have not been published and no information on future drug development are available.