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Positron Emission Tomography (PET) Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease

NCT06053424 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-08-27

No results posted yet for this study

Summary

The purpose of this study is to measure the changes in small bowel uptake of radioligand \[11\^C\]AZ14132516 after intravenous (IV) administration of single and repeat doses of AZD7798 in healthy participants and participants with Crohn's disease.

Study details include:

* The study duration will be variable (adaptive design).
* For Panels 1-5, there will be 5 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 1 residential (24 hour) visit for AZD7798 administration and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit (telephone call).
* For Panel 6, there will be 7 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 2 residential (24 hour) visits for AZD7798 administration, 1 visit for pharmacokinetic (PK) blood sample and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit.

Conditions

Interventions

DRUG

AZD7798

Participants will receive IV infusion of AZD7798 as stated in arm description.

DRUG

[11C]AZ14132516

Participants will receive IV bolus dose of radioligand \[11\^C\]AZ14132516 as stated in arm description.

Sponsors & Collaborators

Principal Investigators

  • Maria Creignou, MD · Karolinska University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2024-10-08
Completion
2024-10-08

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053424 on ClinicalTrials.gov