Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05306366
Other study ID # 19739A
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05718752 - Characterization of the Plasma Metallomic Profile to Acute Exercise in Healthy Men and Women (METALEXO)
Completed NCT03041961 - Aronia Berry Consumption on Vascular Function N/A
Completed NCT01812967 - Mechanism of Action of Milk and Its Components on Glycemic Control in Healthy Young Men N/A