A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants

Healthy Young Men Clinical Trial

Official title:

Interventional Open-Label Positron Emission Tomography Study Investigating Blood-Brain-Barrier Penetration and Pharmacokinetic Properties of [11C]-Lu AF90103 in Healthy Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05306366
• Other study ID #: 19739A
• Status: Completed
• Phase: Phase 1
• Start date: March 23, 2022
• Est. completion date: June 7, 2022

Study information

• Verified date: July 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain when given at tracer levels (microdose) in healthy young men.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• The participant has a body mass index (BMI) =18.5 and =30.0 kilograms (kg)/square meter (m^2) at the Screening Visit.

• 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, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

• The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.

• The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

• The participant has had surgery or trauma with significant blood loss <3 months prior to the first dose of study drug.

• The participant is exposed to significant levels of ionizing radiation at work. Note:

Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy Young Men

Intervention

Drug:
• [11C]-Lu AF90103
PET ligand administrated as a single intravenous bolus injection

Locations

Country	Name	City	State
Sweden	Karolinska Trial Alliance	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Time-Activity Curves for Brain up to 90 Minutes (AUCbrain 0-90 min)		Day 1 (predose and up to 90 minutes postdose)
Primary	Area Under the Blood Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCblood 0-90 min)		Day 1 (predose and up to 90 minutes postdose)
Primary	Area Under the Plasma Concentrations Over Time for [11C]-Lu AF90103 and Radioactive Metabolites up to 90 Minutes (AUCplasma 0-90 min)		Day 1 (predose and up to 90 minutes postdose)
Primary	Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min		Day 1 (predose and up to 90 minutes postdose)
Primary	Total Distribution Volume in the Whole Brain (VT brain)		Day 1 (predose and up to 90 minutes postdose)
Primary	Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu)		Day 1 (predose and up to 90 minutes postdose)