A Study to Evaluate Lu AF90103 in Healthy Men

NCT04940949 | Terminated Phase 1

• 1 other identifier: 18907A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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

  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)

Study Arms (3)

Single Intravenous (IV) Dose of Lu AF90103

EXPERIMENTAL

Participants will receive a single IV dose of Lu AF90103.

Drug: Lu AF90103

Single IV Dose of Placebo

PLACEBO COMPARATOR

Participants will receive a single IV dose of placebo matching to Lu AF90103.

Drug: Placebo

2 Single IV Doses of Lu AF90103

EXPERIMENTAL

Participants will receive 2 single IV doses of Lu AF90103 separated by at least 5 days.

Drug: Lu AF90103

Interventions

Lu AF90103 DRUG

Lu AF90103 - powder for solution for infusion

2 Single IV Doses of Lu AF90103; Single Intravenous (IV) Dose of Lu AF90103

Placebo DRUG

Placebo - powder for solution for infusion

Single IV Dose of Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

QPS Netherlands B.V.

GZ Groningen, 9713, Netherlands

Location

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 28, 2021
• Study Start: May 26, 2021
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

NL (1)