*****THIS STUDY HAS COMPLETED ENROLLMENT*****
Study Purpose
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 people with PWS. The study is looking to enroll 14 individuals between the ages of 13 and 50 years.
Eligible participants will attend five in-clinic site visits at Vanderbilt University Medical Center for PK blood draws and safety assessments over a 6-day period.
The study will consist of a Screening Period 1-3 days prior to the Baseline Visit. In addition to the Screening Visit, eligible participants 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.
Recruitment Criteria
Study Type: Interventional
Eligible Ages: 13 - 50 years
Other Criteria:
See the trial listing at clinicaltrials.gov for a full list of inclusion and exclusion criteria.
Trial Details
ClinicalTrials.Gov Id: NCT05504395
Phase: 1
Duration: 6 days
Lead Sponsor: Consynance Therapeutics
Countries: United States
This study will be available at the following sites:
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Contact: Elizabeth Roof
Questions?
Contact: Lois B Rosenberger, PhD
Phone: 859-426-5035
Email: lrosenberger@lbr-regulartory.com
