Exocrine Pancreatic Insufficiency Clinical Trial
Official title:
A 3-part, Phase 1a/1b, First-in-human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral CDX-7108 in Healthy Adult Subjects and to Evaluate Proof-of-concept Via Pharmacodynamics of a Single Dose of Oral CDX-7108 in Subjects With Exocrine Pancreatic Insufficiency
Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency. No clinical studies have yet been performed with CDX-7108 and its effects in humans are unknown. This is the first-in-human (FIH) study of CDX-7108, which aims to assess the safety, tolerability, pharmacokinetics (PK) of escalating single and multiple oral doses of CDX-7108 in healthy adult subjects and to evaluate the pharmacodynamics of a single dose of oral CDX-7108 in a proof-of-concept (POC) study in subjects with exocrine pancreatic insufficiency (EPI).
This is an integrated 3-part study to investigate the safety, tolerability, PK, and PD of CDX-7108. The Parts A and B are randomized, double-blind, placebo-controlled dose escalation parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single and multiple oral dose administration in healthy adult subjects. Part C is a randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in subjects with EPI. The study will commence with Part A (single ascending dose [SAD] study) and will progress to Part B (multiple ascending dose [MAD] study), and Part C (POC study) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02823964 -
EASY: Extended Access to Sollpura Over Years
|
Phase 4 | |
| Completed |
NCT02563080 -
Pancreatic Exocrine Insufficiency in Acute Pancreatitis
|
||
| Completed |
NCT01427725 -
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
|
||
| Completed |
NCT01430234 -
Enzyme Suppletion in Exocrine Pancreatic Dysfunction
|
Phase 4 | |
| Completed |
NCT03236038 -
Prevalence of Exocrine Pancreatic Insufficiency in Patients With Decompensated Cirrhosis
|
||
| Completed |
NCT03407534 -
Detection of Exocrine Pancreatic Insufficiency in Patients With Diarrhea and Bloating
|
||
| Completed |
NCT02598128 -
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
|
N/A | |
| Completed |
NCT00559364 -
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
|
Phase 3 | |
| Completed |
NCT00408317 -
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
|
Phase 3 | |
| Recruiting |
NCT04548778 -
BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
|
||
| Completed |
NCT00449878 -
Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
|
Phase 3 | |
| Completed |
NCT00981214 -
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
|
Phase 3 | |
| Completed |
NCT00297167 -
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
|
Phase 3 | |
| Recruiting |
NCT05480241 -
Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy
|
N/A | |
| Recruiting |
NCT05261997 -
Endotherapy for Painless Chronic Pancreatitis
|
N/A | |
| Completed |
NCT02370537 -
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
|
Phase 2 | |
| Completed |
NCT00559052 -
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
|
Phase 2 | |
| Recruiting |
NCT04112836 -
Pancreatic Cancer Malnutrition and Pancreatic Exocrine Insufficiency in the Course of Chemotherapy in Unresectable Pancreatic Cancer
|
||
| Completed |
NCT06278272 -
AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients
|
||
| Completed |
NCT02734810 -
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
|
Phase 3 |