A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD)
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age35-85
SponsorH. Lundbeck A/S
About this trial
The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant is Chinese, defined as having four Chinese grandparents being born in China.
The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD).
The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state.
The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator.
Disqualifiers
The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening.
The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation).
The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance.
The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening.
Trial design
Design model
Single group
Treatments tested in this trial
Lu AF28996
DrugCapsule administered orally per schedule specified in the arm description.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Lu AF28996Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame
Up to 60 days2
Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
Time frame
Days 1, 21 or 31, and 413
Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
Time frame
Days 1, 21 or 31, and 414
Time to Reach Cmax (Tmax) of Lu AF28996
Time frame
Days 1, 21 or 31, and 41Sponsors and contacts
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Source ClinicalTrials.gov