Recent Updates
Recently added Catalysts

Hydrocortisone

Phase 2

Adrenal Insufficiency | Small molecule | Endocrine |Takeda Pharmaceutical Company Limited|Last Updated: Nov 24, 2020

Target and mechanism

ModalitySmall molecule

Also known as hydrocortisone, 20 and

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Hydrocortisone · 1 trial · 1 indication

Phase 2 1
NCT00915343Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal InsufficiencyAdrenal Insufficiency
COMPLETED64 Analytics
PHASE2COMPLETED
Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency
Adrenal Insufficiency
NCT0091534364
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A
Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days

AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported.

Secondary Endpoints

Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A
Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A
Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Novel once daily modified releaseEXPERIMENTALTest drug: hydrocortisone (modified release), oral tablet, available as 20 mg and 5 mg. The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state
Conventional TID hydrocortisoneACTIVE_COMPARATORReference drug: hydrocortisone, oral tablet, 10 mg. The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM)in the same total daily dose as the experimental drug. The morning dose was administered in the fasting state.

Interventions

NameTypeDescription
hydrocortisone (modified release), oral tablet 20 and 5 mgDRUGThe modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial
Hydrocortisone, oral tablet, 10 mgDRUGThe reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Previously diagnosed (e.g. more than 6 months ago) primary adrenal insufficiency with a stable daily glucocorticoid substitution dose for at least 3 months prior to study entry * Signed informed consent to participate in the study. Exclusion Criteria: * Clinical or laborator...

Unlock Eligibility Criteria