NCT05175352CompletedPhase 1
A Phase 1, Open-label, Single-sequence Study to Evaluate Potential Disease-mediated Drug-drug Interaction With Selected Cytochrome P450 Substrates in Adult Subjects With Active Eosinophilic Esophagitis Receiving Cendakimab
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Celgene
- Enrollment
- 16
- Locations
- 12
- Primary Endpoint
- Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Study Overview
Brief Summary
The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active Eosinophilic esophagitis (EoE) with histologic evidence as a peak count of ≥ 15 eosinophils per higher-power field at any 2 levels of the esophagus
- •Previously received an adequate trial of proton-pump inhibitor medication that did not provide complete response to EoE
- •EoE symptoms documented in daily diary during the screening period
Exclusion Criteria
- •On a regimen of therapeutic anticoagulation
- •Demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs
- •Currently receiving a high potency topical corticosteroid for dermatologic use
- •Other protocol-defined inclusion/exclusion criteria apply
Arms & Interventions
Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Experimental
Intervention: Cendakimab (Drug)
Administration of Cendakimab and Cytochrome P450 (CYP) substrates
Experimental
Intervention: CYP substrates (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to 12 hours postdose (AUC0-12h)
Time Frame: Up to 18 Weeks
Pharmacokinetics - Area under the concentration-time curve calculated from time zero to infinity (AUC0-∞)
Time Frame: Up to 18 Weeks
Secondary Outcomes
- Pharmacokinetics - Maximum plasma concentration of drug (Cmax)(Up to 18 Weeks)
- Relationship of TEAEs(Up to 34 Weeks)
- Number of participants with clinical laboratory abnormalities(Up to 34 weeks)
- Number of participants with physical examination sign abnormalities(Up to 34 weeks)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Up to 34 Weeks)
- Severity of TEAEs(Up to 34 Weeks)
- Number of participants with electrocardiogram abnormalities(Up to 34 weeks)
- Number of participants with vital sign abnormalities(Up to 34 weeks)
- Immunogenicity profile of cendakimab measured by assessment of the presence of specific anti-drug antibodies (ADAs) over time(Up to 34 Weeks)
Investigators
Study Sites (12)
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