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A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome

Prader-Willi Syndrome Clinical Trial

Official title:
A Phase 1, Single Center, Open Label, Single Dose, Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome

Clinical Trial Summary

The purpose of this Phase 1 study is to evaluate the pharmacokinetics (PK) and safety of a single dose of CSTI-500 10 mg in subjects with Prader-Willi syndrome (PWS) between 13 and 50 years of age with a genetically confirmed diagnosis of PWS.

Clinical Trial Description

This is an open-label, single center, Phase 1 study to evaluate the PK and safety of a 10 mg single oral dose of CSTI-500, a triple monoamine reuptake inhibitor (TRI), in patients with genetically confirmed PWS. The study will consist of a Screening Period of up to 1-3 days prior to the Baseline Visit (Visit 2). In addition to the Screening Visit (Visit 1), eligible subjects will attend five in-clinic site visits for PK blood draws and safety assessments over a 6-day period. At Visit 2 all subjects will receive one single oral dose of CSTI-500 10 mg. Approximately 14 patients aged 13 to 50 years who meet all eligibility criteria will receive one single dose of CSTI-500. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05504395
Study type Interventional
Source ConSynance Therapeutics
Contact
Status Completed
Phase Phase 1
Start date November 14, 2022
Completion date February 21, 2023
View Details
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