Status:
COMPLETED
Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses
Eligibility Criteria
Inclusion
- Healthy young non-smoking men with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.
Exclusion
- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- For Part B: The subject has received radiolabelled material \<12 months prior to the Screening Visit.
- Other inclusion and exclusion criteria may apply
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04082325
Start Date
July 23 2019
End Date
September 24 2020
Last Update
February 24 2021
Active Locations (1)
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1
QPS
Groningen, Netherlands