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

NCT05306366 | Completed Phase 1

• 1 other identifier: 19739A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young Men

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (1)

[11C]-Lu AF90103

EXPERIMENTAL

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

Drug: [11C]-Lu AF90103

Interventions

[11C]-Lu AF90103 DRUG

PET ligand administrated as a single intravenous bolus injection

[11C]-Lu AF90103

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Karolinska Trial Alliance

Huddinge, 141 86, Sweden

Location

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: March 23, 2022
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

SE (1)