Clinical trial
Interventional, Open-label, Single-dose Trial Investigating the Absorption, Metabolism, and Excretion (AME) of Lu AF28996 Following a Single Oral Dosing of 14C-Lu AF28996 to Healthy Men
Name
20436A
Description
The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.
Trial arms
Trial start
2024-04-10
Estimated PCD
2024-05-25
Trial end
2024-05-25
Status
Recruiting
Phase
Early phase I
Treatment
Lu AF28996
Oral solution containing radiolabelled \[14C\]-Lu AF28996.
Arms:
Lu AF28996
Size
8
Primary endpoint
Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)
From baseline (Day -1) up to 23 days post-dose
AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity
From date of dosing (Day 1) up to 23 days post-dose
Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material
From date of dosing (Day 1) up to 23 days post-dose
Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material
From date of dosing (Day 1) up to 23 days post-dose
T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material
From date of dosing (Day 1) up to 23 days post-dose
AUC0-infinity of Lu AF28996
From date of dosing (Day 1) up to 23 days post-dose
Cmax of Lu AF28996
From date of dosing (Day 1) up to 23 days post-dose
Tmax of Lu AF28996
From date of dosing (Day 1) up to 23 days post-dose
T½ of Lu AF28996
From date of dosing (Day 1) up to 23 days post-dose
Eligibility criteria
Key Inclusion Criteria:
* The participant has a Body Mass Index (BMI) \>=18.5 and \<=30 kilograms per square meter (kg/m\^2) and body weight ≥60 kg at the Screening Visit and at the Baseline Visit.
* The participant has a resting supine pulse \>=50 and \<=100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key Exclusion Criteria:
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product \<3 months or \<5 half-lives of that product, whichever is longest, prior to the first dose of investigational medicinal product (IMP).
* Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
Other protocol-defined criteria apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}
Updated at
2024-05-09
1 organization
1 product
1 indication
Organization
H. LundbeckProduct
Lu AF28996Indication
Healthy Participants