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Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease - Trial NCT06053424

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.

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NCT06053424
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06053424
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Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
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

Study Focus

Crohn's Disease

AZD7798

Interventional

drug

Sponsor & Location

AstraZeneca

Stockholm, Sweden

Timeline & Enrollment

Phase 1

Sep 25, 2023

May 06, 2024

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, unspecified
Other Crohn disease
Crohn disease of large intestine
Crohn disease [regional enteritis]
Crohn disease of small intestine

Data Source

ClinicalTrials.gov

NCT06053424

Non-Device Trial