Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease
- Conditions
- HealthyAlzheimer Disease
- Interventions
- Drug: Lu AF87908Drug: Placebo
- Registration Number
- NCT04149860
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy participants and participants with Alzheimer's disease.
- Detailed Description
The study will be divided into three parts: Part A, Part B and Part C.
Part A consists of up to 6 sequential cohorts (Cohorts A1 to A6):
-Cohorts A1 to A6: 8 healthy participants per cohort (aiming for an equal number of men and women): 6 randomized to Lu AF87908 and 2 randomized to placebo.
Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3):
-Cohorts B1 to B3: 4 Japanese and 4 Chinese healthy participants per cohort: 6 participants randomized to Lu AF87908 and 2 participants randomized to placebo.
Part C consists of 2 sequential cohorts (Cohorts C1 and C4):
-Cohort C1 will consist of 6 participants with Alzheimer's disease with 3:1 randomization scheme for active: placebo. Cohort C4 will consist of up to 8 participants. Cohort C4 participants will be randomized based on the randomization scheme from Cohort C1.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Lu AF87908 or Placebo Lu AF87908 Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. Part C: Lu AF87908 or Placebo Placebo Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. Part A: Lu AF87908 or Placebo Placebo Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. Part B: Lu AF87908 or Placebo Lu AF87908 Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. Part B: Lu AF87908 or Placebo Placebo Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. Part C: Lu AF87908 or Placebo Lu AF87908 Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1.
- Primary Outcome Measures
Name Time Method AUC(0-t) of Lu AF87908 From Day 0 to Day 84 Area under the plasma concentration curve for Lu AF87908
Tmax Lu AF87908 From Day 0 to Day 84 Nominal time of occurrence of Cmax of Lu AF97908 in plasma
Number of Participants with Treatment Emergent Adverse Events From Day 0 to Day 84 Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
Cmax of Lu AF87908 From Day 0 to Day 84 Maximum observed plasma concentration for Lu AF87908
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Clinilabs, Inc.
🇺🇸New York, New York, United States
PAREXEL International
🇺🇸Glendale, California, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Panax Clinical Research
🇺🇸Miami, Florida, United States
Research Center of America
🇺🇸Hollywood, Florida, United States
iResearch Atlanta LLC
🇺🇸Decatur, Georgia, United States