Healthy Clinical Trial - A Study to Evaluate Lu AF90103 in Healthy Men

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT04940949
Study type	Interventional
Source	H. Lundbeck A/S
Contact
Status	Terminated
Phase	Phase 1
Start date	May 26, 2021
Completion date	November 23, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06052553` - A Study of TopSpin360 Training Device	N/A
Completed	`NCT05511077` - Biomarkers of Oat Product Intake: The BiOAT Marker Study	N/A
Recruiting	`NCT04632485` - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed	`NCT05931237` - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults	N/A
Terminated	`NCT04556032` - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women	N/A
Completed	`NCT04527718` - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers	Phase 1
Completed	`NCT04107441` - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects	Phase 1
Completed	`NCT04998695` - Health Effects of Consuming Olive Pomace Oil	N/A
Completed	`NCT04065295` - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225	Phase 1
Completed	`NCT01442831` - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects	Phase 1
Terminated	`NCT05934942` - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood	Phase 1
Recruiting	`NCT05525845` - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI	N/A
Completed	`NCT05515328` - A Study in Healthy Men to Test How BI 685509 is Processed in the Body	Phase 1
Completed	`NCT05030857` - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects	Phase 1
Completed	`NCT04967157` - Cognitive Effects of Citicoline on Attention in Healthy Men and Women	N/A
Recruiting	`NCT04494269` - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls	Phase 1
Recruiting	`NCT04714294` - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers	Phase 1
Completed	`NCT04539756` - Writing Activities and Emotions	N/A
Recruiting	`NCT04098510` - Concentration of MitoQ in Human Skeletal Muscle	N/A
Completed	`NCT03308110` - Bioavailability and Food Effect Study of Two Formulations of PF-06650833	Phase 1