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

Phase 1

Completed

• Conditions: Healthy Young Men
• Interventions: Drug: [11C]-Lu AF90103

• Registration Number: NCT05306366
• Lead Sponsor: H. Lundbeck A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Primary Completion: 2022-06-07
• Study Completion: 2022-06-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[11C]-Lu AF90103	[11C]-Lu AF90103	Participants will receive \[11C\]-Lu AF90103 via an intravenous bolus injection on Day 1.

Primary Outcome Measures

Name	Time	Method
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)
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)
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)
Whole Brain-to-Plasma Ratio Expressed by AUCbrain 0-90 min/AUCplasma 0-90 min	Day 1 (predose and up to 90 minutes postdose)
Total Distribution Volume in the Whole Brain (VT brain)	Day 1 (predose and up to 90 minutes postdose)
Ratio Between the Free Concentrations [11C]-Lu AF90103 in Brain Tissue and Plasma (Kp,uu)	Day 1 (predose and up to 90 minutes postdose)

Trial Locations

Locations (1)

Karolinska Trial Alliance; 🇸🇪 Huddinge, Sweden