An open-label, multiple oral dose study to investigate the plasma and CSF pharmacokinetics of CAD-1883 in healthy volunteers
- Conditions
- movement disordersessential tremor (ET)Spinocerebellar ataxia (SCA)
- Registration Number
- NL-OMON47994
- Lead Sponsor
- Cadent Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Subject is male or female of non-childbearing potential, aged between 50 and 65
years (inclusive).
BMI of *18.0 kg/m2 and * 30.0 kg/m2 at Screening.
Healthy as determined by the Investigator, based upon a medical evaluation
including medical history, physical examination, neurological examination, lab
tests and ECG performed at Screening.
Please refer to the protocol for more inclusion criteria
Prior or ongoing medical condition, medical history, physical findings, ECG
findings, laboratory or vital signs abnormality that, in the Investigator*s
opinion, could adversely affect the safety of the subject.
History of physician diagnosed hereditary ataxia or tremor.
History of clinically significant drug allergies.
Please refer to the protocol for more exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic parameters of CAD-1883 including Cmax, tmax, Cmin, Cavg, *z,<br /><br>t1/2, AUC0-t, AUC0-inf, AUC0-tau, AUCextra, CL/F, Vz/F, and AR in plasma.<br /><br>Pharmacokinetic parameters of CAD-1883 including Cmax, tmax, *z, t1/2, AUC0-t,<br /><br>AUC0-inf and AUCextra in CSF.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety parameters include adverse events (AE), physical examination, clinical<br /><br>laboratory values, vital signs, orthostatic vital signs, 12-lead ECG, and<br /><br>C-SSRS scores.</p><br>