A Study to Investigate Safety and Tolerability of NDX-3315 and NDX-3324 in Healthy Participants a… (NCT05757856) | Clinical Trial Compass
CompletedPhase 2
A Study to Investigate Safety and Tolerability of NDX-3315 and NDX-3324 in Healthy Participants and Patients With Eosinophilic Esophagitis
United States34 participantsStarted 2023-01-20
Plain-language summary
An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Healthy Participants:
• Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) assessment.
* EoE Participants:
* Documented diagnosis of EoE (based on prior endoscopy with biopsies showing eosinophils ≥15 / HPF); AND
* History (by patient report) of recurrent dysphagia and/or other related EoE symptoms (with intake of solids off anti-inflammatory therapy) prior to screening; dysphagia is defined as trouble swallowing solid food, or having solid food stuck, by patient report.
Exclusion Criteria:
* Medical Conditions:
* Participant with presence of any other disease of the GI tract, including cancer, autoimmune esophageal disease, GERD which is symptomatic or uncontrolled, Barrett's esophagus, eosinophilic gastritis, enteritis, colitis, or proctitis; inflammatory bowel disease; or celiac disease. Known motility disorder of esophagus; achalasia or suspicion thereof.
* Sleep apnea, if considered by the investigator a concern for the endoscopic procedure.
* History of recurrent aspiration pneumonia.
* History of bleeding disorders, liver cirrhosis or esophageal varices.
* A current malignancy or previous history of cancer in remission for less than 5 years prior to Screening (participants will not be excluded if they had localized carcinoma of the skin that was resected for cure).
* Participant with a Body Mass Index \>40 m2/kg or i…
What they're measuring
1
The proportion of all participants with AEs following administration of NDX-3315 and NDX-3324
Timeframe: From start of study drug administration up to End of Study (EOS) ( Up to 3 Weeks)