NCT06053424

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

Name: Clinical Trial NCT06053424
Creator: AstraZeneca
Keywords: Crohn's Disease, AZD7798, Phase 1, drug, clinical trial, Sweden

A Phase 1b Open Label Positron Emission Tomography Study to Assess Changes in Abdominal [11C]AZ14132516 Uptake Following Administration of Single Doses of AZD7798 to Healthy Participants and Patients With Crohn's Disease

AstraZeneca·Phase 1·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Crohn's Disease
Drug/Device/Intervention: AZD7798
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: AstraZeneca
Location: Stockholm, Sweden

Timeline & enrollment

Phase: Phase 1
Start date: Sep 25, 2023
End date: May 06, 2024
Enrollment: 12 participants

Primary outcome

Change from baseline in small bowel SUV/SUVR

Summary

The purpose of this study is to measure the changes in small bowel uptake of radioligand [11C]AZ14132516 after IV administration of a single dose of AZD7798 in healthy participants and participants with Crohn's disease.  Study details include:  - The study duration will be variable (adaptive design).  - There will be 5 in-person study visits: 1 screening visit, 1 visit for the baseline PET examination, 1 residential (24h) visit for AZD7798 administration and 2 visits for repeated PET examinations. There will be a final follow-up virtual visit (telephone call).

ICD-10 classifications

Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06053424
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06053424 through Pure Global AI's free database. This Phase 1 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on Crohn's Disease. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.