Novel Treatment of Adrenal Crisis: an Early Clinical Trial With Nebulized Prednisolone

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Objective: This study investigates the pharmacokinetics of nebulized prednisolone in two different dosages. Study design: Single-center, open-label study Study population: Healthy participants aged 18-75 years. Intervention (if applicable): Healthy volunteers receive a lower dose of nebulized prednisolone (46.75 mg).After a wash-out period of at least one week, each volunteer receives a higher dose of nebulized prednisolone (93.5 mg). Main study parameters/endpoints: To establish the time from nebulizing to maximum prednisolone concentration in serum and the area under the curve of prednisolone. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are exposed to a single supraphysiological dose of glucocorticoids on two separate occasions. The risk of SAE is very limited. There is a small risk of an AE during blood sampling. If it is demonstrated that therapeutic plasma concentrations of prednisolone can be reached by nebulizing prednisolone, we intend to use the pharmacokinetic data to design and perform a clinical study with a dry-powder micronized prednisone inhalation. This would represent a novel and promising alternative treatment for an adrenal crisis. Patients with adrenal insufficiency could then be offered a much more patient-friendly and reliable alternative for intramuscular hydrocortisone injection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Age: 18 - 75 years

• Woman who use reliable contraceptives or with a negative pregnancy test

• Equal sex distribution

Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Annet Vulto, MD
a.vulto@umcg.nl
+31503617293
Time Frame
Start Date: 2022-11-03
Completion Date: 2023-03-01
Participants
Target number of participants: 12
Treatments
Experimental: Low dose, wash out, high dose
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov

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