Clinical trial
Interventional, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study Part Investigating the Safety, Tolerability, and Pharmacokinetic and -Dynamic Properties of Lu AF90103 and a Double-Blind, Cross-Over Study Part Investigating the Safety Profile After Infusion of Lu AF90103 at Two Rates to Healthy Men
Name
18907A
Description
The purpose of this study is to investigate the safety and tolerability of Lu AF90103 and what the body does to Lu AF90103 after single doses of the drug administered directly into a vein.
Trial arms
Trial start
2021-05-26
Estimated PCD
2021-11-23
Trial end
2021-11-23
Status
Terminated
Phase
Early phase I
Treatment
Lu AF90103
Lu AF90103 - powder for solution for infusion
Arms:
2 Single IV Doses of Lu AF90103, Single Intravenous (IV) Dose of Lu AF90103
Placebo
Placebo - powder for solution for infusion
Arms:
Single IV Dose of Placebo
Size
15
Primary endpoint
Number of Participants With Treatment-Emergent Adverse Events
From dosing (Day 1) to Day 16
Maximum Observed Concentration (Cmax) of Lu AF90103 and AF88361 in Plasma and Cerebrospinal Fluid (CSF)
0 (predose) up to 96 hours postdose on Day 1 to Day 5
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Lu AF90103 and AF88361 in Plasma and CSF
0 (predose) up to 96 hours postdose on Day 1 to Day 5
Total Clearance (CL) of Lu AF90103 and AF88361
0 (predose) up to 96 hours postdose on Day 1 to Day 5
Amount of Lu AF90103 and Lu AF88361 Excreted in Urine
0 (predose) up to 96 hours postdose on Day 1 to Day 5
Changes to Time Matched Baseline in Area Under the Curve (AUC) of Medial Prefrontal (FZ and CZ Electrodes) High Frequency Gamma Signal (100-170 Hertz [HZ]) for Lu AF90103 at the Resting State
From dosing (Day 1) to Day 4 (Part A) and Day 9 (Part B)
Eligibility criteria
Inclusion Criteria:
* The participant is ≥18 and ≤45 years of age at the Screening Visit for Cohorts A1 to A6 (excluding cohort A2b) or ≥55 to ≤65 for participants in the CSF sampling Cohorts A2b and A7.
* The participant has body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m\^2) and ≤30 kg/m\^2 and body weight ≥60 kilograms (kg) at the Screening Visit and at the Baseline Visit.
* The participant has a normal resting electroencephalogram (EEG) at Screening.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Exclusion Criteria:
* The participant 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.
Other inclusion and exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-03-16
1 organization
2 products
1 indication
Product
Lu AF90103Indication
HealthyOrganization
H. LundbeckProduct
Placebo