Interventional, exploratory, open-label trial of Lu AF28996 in Japanese men and women with Parkinson's disease

JRCT ID: jRCT2061230047

Registered date:12/08/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 12/09/2023
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Lu AF28996 administered orally

Outcome(s)

• Primary Outcome: To evaluate the safety, tolerability and pharmacokinetics of Lu AF28996 in Japanese men and women with Parkinson's disease

Key inclusion & exclusion criteria

• Age minimum: >= 45age old
• Age maximum: <= 75age old
• Gender: Both

Include 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 <=75 years o f age at the Screening Visit.

5. If the participant is a man, he must:
- have been surgically sterilized (bilateral surgical vasectomy or bilateral orchiectomy) prior to the Screening Visit
OR
- remain sexually abstinent, when this is in line with his preferred and usual lifestyle
OR
- engage exclusively in same-sex relationships
OR
- engage in sexual relationships with a female partner of non-childbearing potential, defined as:
- a woman who had her last natural menstruation >=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

Exclude 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.

Related Information

• Primary Sponsor: Yazawa Masanari
• Secondary ID(s): NCT06004180