Pharmacokinetics, Efficacy, Tolerability and Safety of Different Budesonide Oral Gel Doses in Adults' Subjects of Both Genders With Eosinophilic Esophagitis (EoE)
- Conditions
- Eosinophilic Esophagitis
- Registration Number
- NCT05214599
- Lead Sponsor
- Bazell Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria:<br><br> - Subjects able to read, understand and sign the Informed Consent Form (ICF) approved<br> by Ethical Committee;<br><br> - Male and female subjects aged between 18 and 75 years old;<br><br> - Body weight between 60-100 kg;<br><br> - Body mass index (BMI) = 18.5 and = 29.9 kg/m2;<br><br> - Non-childbearing potential female subjects. Childbearing potential is defined as:<br> post-menopausal women (defined as 12 months of amenorrhea or more), hysterectomized<br> women, oophorectomized (bilateral) women and/or those who underwent tubal ligation;<br><br> - Female participants of childbearing potential who test negative for the pregnancy<br> test on the day of administration of the first dose of the drug (Visit 1), as well<br> as throughout the clinical trial;<br><br> - Female participants who practice adequate contraception or who abstain from all<br> activities that could result in pregnancy for at least 28 days before administering<br> the first dose of the drug (Visit 1);<br><br> - Female participants who agree to continue adequate contraception for 1 month after<br> administration of the last dose of the investigational drug;<br><br> - Participants diagnosed with EoE, verified from a combination of symptoms compatible<br> with EoE and histological finding greater than 15 eosinophils per high-power field<br> in at least one esophageal mucosal biopsy;<br><br> - Participants unresponsive to stable dose of proton-pump inhibitor (PPI).<br><br>Exclusion Criteria:<br><br> - Subjects with a malignancy history within the last 5 years, except from successfully<br> treated basal cell carcinoma;<br><br> - History of esophageal stenosis requiring dilation and/or stenosis at endoscopy not<br> allowing to pass the endoscope;<br><br> - Subjects with a eosinophilic gastroenteritis diagnosis (presence of eosinophilic<br> infiltrate in gastric antrum and duodenum);<br><br> - Subjects with a reflux esophagitis history;<br><br> - Subject with a previous serious asthma diagnosis;<br><br> - Subjects with a gastroesophageal tract disease that, at the investigator's<br> discretion, is deemed as an obstacle to take part in the trial;<br><br> - People with chronic diseases on regular drugs that, in the investigator's opinion,<br> may interfere with the trial;<br><br> - Medical conditions such as serious heart or lung diseases preventing the safe<br> performance of endoscopy;<br><br> - Subjects with conditions known to be related to esophageal eosinophilia, including<br> Crohn's disease, Churg-Strauss, achalasia and hypereosinophilic syndrome;<br><br> - Subjects who have been on oral, intranasal or systemic corticosteroid at least 15<br> days prior to trial start;<br><br> - Smoker of having quit smoking less than 6 months ago;<br><br> - Have a history of excessive alcohol intake for at least 6 months prior to trial<br> start (intake of 5 or more alcoholic beverages in one day or 15 or more alcoholic<br> beverages per week);<br><br> - Subjects having 5 or more cups of tea or coffee per day and who cannot abstain from<br> them for the trial period;<br><br> - Be on CYP3A4 inhibitors, such as ketoconazole and grapefruit juice;<br><br> - Electrocardiogram (ECG) findings that, in the investigator's opinion, may jeopardize<br> participation in the trial;<br><br> - History or presence of gastrointestinal or liver disease or other condition<br> interfering with drug absorption, distribution, excretion or metabolism;<br><br> - Subjects with hypersensitivity or contraindication of using any formulation<br> components;<br><br> - Subjects who have been part of trial protocols in the last 12 (twelve) months (CNS<br> Resolution 251, dated August 7, 1997, item III, sub-item J);<br><br> - Have donated blood (> 500 mL) or undergone major surgery within the 3 months prior<br> to the ICF signature date;<br><br> - Have been vaccinated for the 30 days prior to admission;<br><br> - Clinical evidence of infectious process potentially contributing for dysphagia<br> (candidiasis, cytomegalovirus (CMV), herpes);<br><br> - Other dysphagia cause identified at endoscopy (peptic stenosis, web, ring,<br> achalasia, esophageal neoplasm);<br><br> - Breastfeeding subjects, who plan to become pregnant or with a positive pregnancy<br> test during the trial;<br><br> - Any medical condition or laboratory change that, in the investigator's opinion, may<br> jeopardize participation in the trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of Pharmacokinetic Profiles;Determination of Pharmacokinetic Profiles;Determination of Pharmacokinetic Profiles;Determination of Pharmacokinetic Profiles;Proportion of subjects reaching a histological response;Improvement in dysphagia symptoms consistent with the disease
- Secondary Outcome Measures
Name Time Method Assessment of non-serious and serious adverse events rate;Quality of life assessment of subjects