A Study to Evaluate Lu AF90103 in Healthy Men

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04940949
• Other study ID #: 18907A
• Status: Terminated
• Phase: Phase 1
• Start date: May 26, 2021
• Est. completion date: November 23, 2021

Study information

• Verified date: March 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AF90103
Lu AF90103 - powder for solution for infusion
• Placebo
Placebo - powder for solution for infusion

Locations

Country	Name	City	State
Netherlands	QPS Netherlands B.V.	GZ Groningen

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events		From dosing (Day 1) to Day 16
Primary	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
Primary	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
Primary	Total Clearance (CL) of Lu AF90103 and AF88361		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	Amount of Lu AF90103 and Lu AF88361 Excreted in Urine		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	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).	From dosing (Day 1) to Day 4 (Part A) and Day 9 (Part B)