A Study to Evaluate Lu AF90103 in Healthy Men

Phase 1TerminatedNCT04940949

H. Lundbeck A/S15 enrolled

Overview

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.

This study is the first-in-human (FIH) study with Lu AF90103. The study is divided in two parts, Part A and Part B. Part A is an interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Lu AF90103 in healthy men. Part B is an interventional, randomized, double-blind, cross-over study to investigate the safety profile after administration of Lu AF90103 as an infusion at two different rates to healthy young men. The dosage in Part B is guided by the cohorts in Part A and is a repetition of one of the doses from Part A. The total study duration per participant from baseline to the end of follow-up will be maximum 11 days in Part A and 16 days in Part B.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Lu AF90103DRUG

Lu AF90103 - powder for solution for infusion

PlaceboDRUG

Placebo - powder for solution for infusion

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

QPS Netherlands B.V.

GZ Groningen, Netherlands

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events

Time frame: From dosing (Day 1) to Day 16

Maximum Observed Concentration (Cmax) of Lu AF90103 and AF88361 in Plasma and Cerebrospinal Fluid (CSF)

Time frame: 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

Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

Total Clearance (CL) of Lu AF90103 and AF88361

Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

Amount of Lu AF90103 and Lu AF88361 Excreted in Urine

Time frame: 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

The AUC of medial prefrontal (FZ and CZ electrodes) high frequency gamma signal (100-170 HZ) will be derived for Lu AF90103 at resting state, as measured by electroencephalogram (EEG).

Time frame: From dosing (Day 1) to Day 4 (Part A) and Day 9 (Part B)

Data from ClinicalTrials.gov

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