A phase 1b study to evaluate the pharmacokinetics and safety of CLE-600 in patients with Parkinson*s disease
- Conditions
- Parkinson's disease10028037
- Registration Number
- NL-OMON53497
- Lead Sponsor
- Clexio Biosciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Sex : male or female; females must be of nonchildbearing potential or
postmenopausal.
2. Age : 40 to 80 years, inclusive, at screening.
3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening.
4. Weight : >=50 kg, at screening.
5. Status : PD patients (diagnosed according to UK PD Society Brain Bank
Criteria).
Further criteria apply
1. Previous participation in the current study.
2. Employee of ICON or the Sponsor.
3. History of alcohol abuse or drug addiction within the last year (including
soft drugs like cannabis products), except for tobacco use disorder.
4. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, and alcohol)
at screening or admission (Day 1 for Part A and Day -1 for Part B) to the
clinical research center. For cannabinoids, in case of a positive screen the
Investigator should decide whether this is related to medical or recreational
use (then subject may be included) or to drug addiction (then subject should be
excluded).
5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
Further criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- CD and LD PK parameters: Cmax, Tc above 450ng/ml, Tmax, AUC0-t, AUC0-inf,<br /><br>t1/2, Tlag as applicable<br /><br>- Safety and tolerability: Incidence of adverse events, vital signs, clinical<br /><br>laboratory tests and ECG</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>