movement disorders essential tremor (ET) Spinocerebellar ataxia (SCA)
Conditions
Interventions
Sponsors
Cadent Therapeutics Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of CAD-1883 including Cmax, tmax, Cmin, Cavg, *z, t1/2, AUC0-t, AUC0-inf, AUC0-tau, AUCextra, CL/F, Vz/F, and AR in plasma. Pharmacokinetic parameters of CAD-1883 including Cmax, tmax, *z, t1/2, AUC0-t, AUC0-inf and AUCextra in CSF. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters include adverse events (AE), physical examination, clinical laboratory values, vital signs, orthostatic vital signs, 12-lead ECG, and C-SSRS scores. | — |
Countries
Netherlands
Outcome results
None listed