To assess the effect of the CRH on duodenal mast cell count, eosinophil count, immune activation, mucosal permeability and gastric sensorimotor function and gastrointestinal symptoms.
Conditions
Interventions
Trade Name: CRH Ferring
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Corticorelin triflutate
CAS Number: 121249-14-7
Current Sponsor code: CORTICORELIN TRIFLUTATE
Other de
Sponsors
University Hospitals Leuven (UZ Leuven)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. Women of child-bearing potential agree to apply a highly effective methods of birth control; 3. Healthy volunteers 4. Subjects aged 18-70 years old (70y included). 5. Male or female subjects. 6. Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol 2. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 4. Presence of a history of gastrointestinal surgery other than appendectomy 5. Presence of organic or functional gastrointestinal disease 6. Presence of gastro-intestinal symptoms 7. Major psychiatric disorder such as major depression 8. Presence of any disease affecting the gastrointestinal tract or hepatobiliary system. 9. History of allergic reaction to CRH 10. Use of drugs included in this list: a. Opioids (unless short intake for acute pain and > 1month ago) b. Amitriptyline or mirtazapine; other antidepressants are allowed if the HV is on a stable dose and the drug is not combined with other antidepressants. c. Corticosteroids d. Antihistaminic drugs (last 2 weeks) e. Proton pump inhibitors (last 2 weeks) f. Disodiumchromoglycate or other mast cell stabilizers (last 2 weeks) g. Leukotriene receptor antagonists (last 2 weeks) h. NSAIDs (last 2 weeks) i. Antibiotics (last 2 months) j. Probiotics (last 2 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Part 1 ?The effect of CRH on duodenal eosinophilia in healthy volunteers ?The effect of CRH on markers of immune activation in healthy volunteers ? The effect of CRH on duodenal mucosal permeability in healthy volunteers Part 2 ?The effect of CRH on gastric accommodation in healthy volunteers ?The effect of CRH on gastroduodenal symptoms in healthy volunteers ?The effect of CRH on gastric emptying time in healthy volunteers ?The effect of CRH on salivary cortisol level in healthy volunteers ;Primary end point(s): Part 1 To determine duodenal mast cell count after administration of CRH vs. placebo Part 2 To determine sensitivity to gastric distention after administration of CRH vs. placebo;Timepoint(s) of evaluation of this end point: Part 1 2 hours after IMP/Placebo administration Part 2 Evaluation will start during MP/Placebo administration ;Main Objective: Part 1 ?The effect of corticotrophin release hormone (CRH) on duodenal mast cell count in healthy volunteers Part 2 ?The effect of CRH on sensitivity to gastric distention in healthy volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1: ? The effect of CRH (vs placebo) on duodenal eosinophilia. ? The effect of CRH (vs placebo) on markers of immune activation. ? The effect of CRH (vs placebo) on duodenal mucosal permeability Part 2: ? The effect of CRH (vs placebo) on gastric emptying time ? The effect of CRH (vs placebo) on gastric accommodation ? The effect of CRH (vs placebo) on gastroduodenal symptoms. ? The effect of CRH (vs placebo) on salivary cortisol level;Timepoint(s) of evaluation of this end point: Part 1 Before and 2 hours after IMP/Placebo administration Part 2 Evaluation will start during MP/Placebo administration | — |
Countries
Belgium
Contacts
Public ContactTARGID
KU Leuven
Outcome results
None listed