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

NCT05504395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CSTI-500

Single 10 mg capsule

Sponsors & Collaborators

  • ConSynance Therapeutics

    lead INDUSTRY

Principal Investigators

  • Italo Biaggioni, MD · Vanderbilt Autonomic Dysfunction Center, Vanderbilt University Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-02-21
Completion
2023-02-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504395 on ClinicalTrials.gov