NCT05504395

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ConSynance Therapeutics · Industry
• Sex: All
• Age: 13 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	CSTI-500	Single 10 mg capsule

Timeline

• Start date: 2022-11-14
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2022-08-17
• Last updated: 2023-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study