Parkinson's disease
Conditions
Interventions
Lu AF28996 administered orally
Sponsors
Yazawa Masanari
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant is diagnosed with idiopathic PD (consistent with the United Kingdom Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of Parkinson's Disease) and should not have more than 1 first-degree relative with PD. 2. The participant experiences well recognizable and predictable motor fluctuations (>=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. 3. The participant currently has a good response to levodopa and has been receiving a stable dose of levodopa >=3 doses per day of levodopa/dopa decarboxylase inhibitor therapy) >=4 weeks prior to screening. 4. The participant is >=45 and =12 months prior to the Screening Visit OR - a woman who was surgically sterilized (bilateral fallopian tubal ligation, bilateral salpingo oophorectomy, or bilateral oophorectomy) or had a hysterectomy prior to the Screening Visit OR - agree to avoid impregnating his partner, if the partner is considered to be of childbearing potential, from the Screening Visit until >=3 months after the last dose of IMP by using contraception AND - not donate sperm from the Screening Visit until >=3 months after the last dose of IMP 6. If the participant is a woman, considered to be of childbearing potential, she must: - remain sexually abstinent, when this is in line with her preferred and usual lifestyle OR - engage exclusively in same-sex relationships OR - have a male partner who was surgically sterilized (bilateral surgical vasectomy or bilateral orchiectomy) prior to the Screening Visit OR agree to avoid becoming pregnant from the Screening Visit until >=1 month after the last dose of IMP by using a highly effective method of contraception AND - not donate ova from the Screening Visit until >=1 month after the last dose of IMP
Exclusion criteria
Exclusion criteria: 1. The participant is a member of the site staff or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the site staff. 2. The participant has taken any investigational medicinal product <3 months or <5 half-lives, whichever is longer, prior to the Screening Visit. 3. The participant is pregnant or breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods. 4. The participant has undergone any eye surgery within 3 months prior to the Screening Visit. 5. The participant has a disease or takes medication that could, in the opinion of the investigator, interfere with the assessments of safety, tolerability, or pharmacodynamics, or interfere with the conduct or interpretation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability and pharmacokinetics of Lu AF28996 in Japanese men and women with Parkinson's disease | — |
Contacts
Public ContactTakanori Narita
PPD-SNBL K.K.
Outcome results
None listed