Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency (PHYSCA)

Bruno Allolio

Status and phase: Completed; Phase 2

Conditions: Primary Adrenal Insufficiency

Treatments: Drug: Hydrocortisone subcutaneously first; Drug: Hydrocortisone intramuscular first

Study type: Interventional

Funder types: Other

Identifiers

NCT01450930

PHYSCA-1

2011-002687-25 (EudraCT Number)

Details and patient eligibility

About

Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.

Enrollment: 12 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
• age ≥ 18 years,
• Patient´s written informed consent,
• Ability to comply with the protocol procedures

Exclusion criteria

• Diabetes mellitus,
• Infectious disease with fever at time of investigation,
• Known intolerance to the study drug or constituents oft he study drug,
• Oral contraception,
• Known pregnancy or breast feeding,
• Renal failure (creatinine > 2.5 ULN)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Hydrocortisone subcutaneously first

Active Comparator group

Description:

Hydrocortisone subcutaneously first

Treatment:

Drug: Hydrocortisone subcutaneously first

Hydrocortisone intramuscular first

Active Comparator group

Description:

Hydrocortisone intramuscular first

Treatment:

Drug: Hydrocortisone intramuscular first