Recent Updates
Recently added Catalysts

Hydrocortisone Modified Release

Phase 2

Endocrine Disease | Small molecule | Endocrine |Neurocrine Biosciences, Inc.|Last Updated: May 17, 2017

Target and mechanism

ModalitySmall molecule

Also known as Hydrocortisone Modified Release Capsules

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Hydrocortisone Modified Release · 1 trial · 3 indications

Phase 2 1
NCT01735617Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAHEndocrine Disease
COMPLETED16 Analytics
PHASE2COMPLETED
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH
Endocrine Disease
NCT0173561716
Unlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
24 hours

The maximum plasma concentration (Cmax) of chronocort

Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)

Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
24 hours

Time to maximum plasma concentration (tmax)

Secondary Endpoints

The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
Specific time point (0700hrs)
17-OHP Levels at 0700h, 1700h and 2300h
Specified time points (0700h, 1700h and 2300h)
Androstenedione Levels at 0700h, 1700h and 2300h
Specified time points (0700h, 1700h and 2300h)
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hydrocortisone Modified Release CapsulesEXPERIMENTALChronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Interventions

NameTypeDescription
Hydrocortisone Modified Release CapsulesDRUGPatients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months. 2. Male or female patients aged 18 and above. 3. Provi...

Countries:United States
Unlock Eligibility Criteria