Primary ObjectiveTo determine the plasma and cerebrospinal fluid (CSF) pharmacokinetic (PK) profile of multiple oral doses of CAD-1883 in healthy subjects.Secondary ObjectiveTo evaluate the safety and tolerability of multiple oral doses of CAD-1883…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
movement disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Safety parameters include adverse events (AE), physical examination, clinical
laboratory values, vital signs, orthostatic vital signs, 12-lead ECG, and
C-SSRS scores.
Background summary
CAD-1883 is a novel, first-in-class, small-molecule, positive allosteric
modulator of small- conductance calcium-activated potassium channels (SK
channels) which is being developed for the treatment of spinocerebellar ataxia
(SCA) and essential tremor (ET).
Study objective
Primary Objective
To determine the plasma and cerebrospinal fluid (CSF) pharmacokinetic (PK)
profile of multiple oral doses of CAD-1883 in healthy subjects.
Secondary Objective
To evaluate the safety and tolerability of multiple oral doses of CAD-1883 in
healthy subjects.
Exploratory Objective
To determine kidney injury biomarkers in urine (results will be reported
separately).
Study design
This is a single site, open-label, multiple oral dose study in 1 cohort of
healthy subjects.
After assessing eligibility during a screening period of up to 4 weeks, 8
subjects will be included.
Subjects will check into the clinic one day prior to first dosing (Day -1).
Subjects will be released from the clinic on Day 16 after all required study
procedures are completed and if medically justified.
Each subject will receive 600 mg CAD-1883 BID from Day 1 up to and including
Day 14. Dosing is scheduled at approximately midnight and approximately 8:00 AM.
Upon completion of the treatment period, or early withdrawal, subjects will
return to the clinic approximately 7 days after the last dosing of study drug
for a follow-up visit.
Intervention
CAD-1883
Study burden and risks
Since the study is being executed in healthy volunteers, there are no
anticipated benefits of the IMP. Please see the IMPD for further information.
Hamilton Street 60
Cambridge MA 02139
US
Hamilton Street 60
Cambridge MA 02139
US
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003471-18-NL |
| CCMO | NL71292.056.19 |