Phase 2
Completed N=16
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH
Source: ClinicalTrials.gov NCT01735617 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia — 601.213 nmol/L
Summary
The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH). Hydrocortisone is the man-made version of the hormone cortisol, which is released in the body following a regular daily pattern. The objective of the study is to measure the levels of hydrocortisone that are absorbed into the bloodstream once Chronocort® is taken and what affects it has on other hormones in the body. Since Chronocort® is anticipated to mimic the same release pattern of cortisol in the body, it is hoped that patients with CAH will be treated more effectively to manage their disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia |
601.213 | — |
| PRIMARY Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia |
5027.641 | — |
| PRIMARY Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia |
7.9 | — |
| SECONDARY 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) |
0; 12.5; 56.3; 81.3 | — |
| SECONDARY 17-OHP Levels at 0700h, 1700h and 2300h |
76.97; 70.99; 55.35; 7.72; 23.55; 27.27 | — |
| SECONDARY Androstenedione Levels at 0700h, 1700h and 2300h |
7.92; 7.54; 7.43; 3.11; 4.62; 5.37 | — |
| SECONDARY ACTH Levels at 0700h, 1700h and 2300h |
21.06; 20.93; 7.75; 4.16; 4.71; 7.37 | — |
| SECONDARY AUC Values (Nmol*h/L) for Androstenedione |
166.19; 41.42; 65.33; 59.44; 104.37; 36.02 | — |
| SECONDARY AUC Values (Nmol*h/L) for 17-OHP |
1407.83; 243.99; 607.74; 556.11; 446.90; 169.83 | — |
| SECONDARY AUC Values (Pmol*h/L) for ACTH |
356.25; 54.72; 166.18; 135.35; 120.00; 52.22 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Male or female patients aged 18 and above.
- Provision of signed written informed consent.
- Good general health.
- Females of childbearing potential must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using a medically acceptable method of contraception (as defined in the protocol, section 10.5).
- Plasma renin activity must be within the clinically acceptable range at screening (less than 1.5 times upper normal range).
Exclusion Criteria
- Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of glucocorticoids.
- Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (ALT or AST) > 2 times the upper limits of normal.
- Females who are pregnant or lactating.
- Women taking an estrogen-containing oral contraceptive pill and who have taken it within 6 weeks of recruitment.
- Patients taking spironolactone.
- Patients on inhaled or oral steroids apart from treatment for CAH.
- Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
- Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
- Patients with history of bilateral adrenalectomy.
Data sourced from ClinicalTrials.gov (NCT01735617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.