Main objectives:To evaluate the safety and tolerability of Lu AF28996 after up-titration of oral dose(s) in patients with Parkinson's Disease (PD)To investigate the pharmacokinetic properties of Lu AF28996 after up-titration of oral dose(s) in…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Number of participants with treatment-emergent adverse events.
Safety and tolerability based on the safety assessments (clinical safety
laboratory tests, vital signs, weight, ECG parameters and physical
examination).
2. Cmax Lu AF28996.
Maximum observed plasma concentration of Lu AF28996.
3. AUC(0-24h) Lu AF28996.
Area under the plasma concentration time curve from zero to infinity.
4. CL/F Lu AF28996
Oral clearance for Lu AF28996 in plasma.
Secondary outcome
N/A
Background summary
Lu AF28996 has been administered to healthy volunteers before, but is not
registered as a medicine. It is a compound that is being developed for the
treatment of Parkinson*s disease. Parkinson*s disease is a brain disorder in
which the control of certain muscle movements by the brain is affected. This is
because in this disease the cells that produce dopamine, a substance that
transmits signals between cells, in the brain slowly die. The resulting
dopamine deficit can cause tremors and motor impairments as well as other
cognitive symptoms. Lu AF28996 mimics the activity of dopamine and can
therefore potentially be used for the treatment of Parkinson*s disease.
Study objective
Main objectives:
To evaluate the safety and tolerability of Lu AF28996 after up-titration of
oral dose(s) in patients with Parkinson's Disease (PD)
To investigate the pharmacokinetic properties of Lu AF28996 after up-titration
of oral dose(s) in patients with PD
Study design
This is an interventional, open-label, exploratory study, investigating the
safety, tolerability, pharmacokinetics, and efficacy of Lu AF28996 in patients
with Parkinson*s disease.
12 patients are planned for enrollment, but, if deemed necessary, up to 15
patients can be enrolled. Patients will be recruited from specialist settings
within PD.
The study will, for this study design, comprise 3 cohorts (Cohorts 2-4) and
include 3 patients in Cohort 2 and 4 patients (men or women) in both Cohorts 3
and 4, with the possibility of adding 1 more cohort (Cohort 5) including 4
patients. All cohorts will be open-label, sequential cohorts.
Intervention
Lu AF28996 hard capsules
Study burden and risks
There are no distinct benefits for participating in this study. Your
participation will provide information about the study drug. This might benefit
others in the future. Disadvantage of participation in the study may be the
discomforts of the tests performed in the study and the occurrence of side
effects.
Ottiliavej 9 Ottiliavej 9
Valby DK-2500 Valby
DK
Ottiliavej 9 Ottiliavej 9
Valby DK-2500 Valby
DK
Listed location countries
Age
Inclusion criteria
- The patient is able to read and understand the Subject Information Sheet and
Informed Consent Form.
- The patient has signed the study-specific Informed Consent Form.
- The patient is diagnosed with idiopathic Parkinson*s disease (consistent with
the UK Parkinson*s Disease Society Brain Bank Criteria for the Diagnosis of PD)
and should not have more than 1 first-degree relative with PD.
- The patient*s Modified Hoehn and Yahr score is *3 in the ON state and *4 in
the OFF state.
- The patient experiences well recognizable and predictable motor fluctuations
(at least 1.5 hours of OFF-periods in the awake time, predictable morning OFF
episodes included) causing clinically significant disability during the 7-week
Screening Period.
Exclusion criteria
- The patient has previously been enrolled in this study.
- The patient takes or has taken disallowed recent or concomitant medication
(specified in Appendix II of the CSP) or it is anticipated that the patient
will require treatment with at least one of the disallowed concomitant
medications during the study. Patients who have taken any non-prescribed
systemic or topical medication may participate in the study if, in the opinion
of the investigator, the medication will not interfere with the study
procedures, study results, or compromise safety.
- The patient is a member of the study personnel or of their immediate
families, or is a subordinate (or immediate family member of a subordinate) to
any of the study personnel.
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 | EUCTR2019-001280-77-NL |
| CCMO | NL71423.056.19 |