Research study to investigate the safety, tolerability and effects of multiple doses of LTI-291 in healthy middle aged and older volunteers.
- Conditions
- GBA-Associated parkinsonism, movement disorder
- Registration Number
- NL-OMON24313
- Lead Sponsor
- •Lysosomal Therapeutics Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Signed informed consent prior to any study-mandated procedure
2.Healthy male or female subjects of non-childbearing potential (defined as postmenopausal with amenorrhea for at least 12 months) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy, 50 to 75 years of age (inclusive) at screening.
1.Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature), 12-lead electrocardiogram (ECG)). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.
2.Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Safety and tolerability endpoints<br /><br>•Pharmacokinetic endpoints<br /><br>•Pharmacodynamic safety biomarker endpoints<br>
- Secondary Outcome Measures
Name Time Method •Wet biomarker measurements<br /><br>•Genotyping<br>