Interventional, open-label, single- and sequential-ascending-dose study investigating the safety, tolerability and pharmacokinetic profile of Lu AF28996 in healthy young men.
Completed
- Conditions
- movement disorders10028037
- Registration Number
- NL-OMON48715
- Lead Sponsor
- QPS Netherlands B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 39
Inclusion Criteria
Healthy, young, non-smoking men aged *18 and *45 years and with a body mass index (BMI) *18.5kg/m2 and *30kg/m2 at the Screening Visit, who has demonstrated tolerability to oral pramipexol. ;Further inclusion criteria can be found in the protocol on page 45/46.
Exclusion Criteria
1. The subject has taken disallowed medication <1 week prior to the first dose of IMP or 5 half-lives prior to the Screening Visit for any medication taken.
2. The subject has significant alcohol consumption.
3. The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP.;Further exclusion criteria can be found in the protocol on page 46/47
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability<br /><br>Compare PK of solution or capsule<br /><br>Evaluate food effect on PK on capsule </p><br>