NCT02408068

Brief Summary

The purpose of the study is to find out whether food has an effect on the way the body deals with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate release hydrocortisone (fasted). This information will be used to help doctors with dosing in clinical practice.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

December 15, 2017

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 10, 2015

Results QC Date

February 26, 2016

Last Update Submit

April 5, 2022

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (6)

  • Chronocort Cmax

    Comparison of fed and fasted Chronocort Cmax for serum cortisol.

    24 hours

  • Comparison of Fed and Fasted Chronocort AUC0-t

    Area under the curve from 0 to 24 hours for serum cortisol. Please note that the AUC0-t will be presented as a single figure (geometric mean) to represent exposure over time. N.B., the sampling points for Hydrocortisone are as follows: 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h and 12h post-dose. However, the results for Hydrocortisone will not be incorporated into the analysis for this outcome measure.

    24 hours (at 0h, then 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h, 13h, 14h, 15h, 16h, 18h, 20h, 22h and 24h post-dose.)

  • Comparison of Fed and Fasted Chronocort Tmax

    Comparison of Fed and Fasted Chronocort based on the time to achive the maximum concentration of serum cortisol

    24 hours

  • Bioavailability of Chronocort® vs Hydrocortisone Tablets - Cmax

    Evaluation of the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state by Cmax

    24 hours

  • Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using AUC0-t

    To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using area under the curve

    24 hours

  • Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using Tmax.

    To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using Tmax.

    24 hours

Study Arms (3)

Chronocort : fed

ACTIVE COMPARATOR

Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and receive a high fat, high calorie breakfast on the morning of Day 1. Thirty minutes after the start of the breakfast they will receive 20mg of modified release hydrocortisone with 200 millilitres of water, and no further food for 4 hours, water will be allowed from 1 hour after the food. Further dexamethasone doses will be given at 06:00, 12:00, 18:00 and 22:00 hours on Day 1. One baseline pharmacokinetics (PK) sample will be taken starting prior to the dose and then over 24 hours (29 samples).

Drug: DexamethasoneDrug: Chronocort: fed

Immediate release hydrocortisone: fasted

ACTIVE COMPARATOR

Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg immediate release hydrocortisone with 200 millilitres of water on the morning of Day 1. Water will be allowed 1hr after the study drug, but no food for at least 4hrs post dose. Further dexamethasone doses will be given at 06:00, 12:00 and 18:00 hours on Day 1. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)

Drug: DexamethasoneDrug: Immediate release hydrocortisone: fasted

Chronocort: fasted

ACTIVE COMPARATOR

Volunteers will be admitted, take dexamethasone at 22.00hrs, fast overnight, and take 20mg modified release hydrocortisone with 200millilitres of water on the morning of Day 1. Water will be allowed 1hr after the dose, but no food for at least 4hrs post dose. Further dexamethasone doses will be given at 06:00, 12:00, 18:00 and 22:00 hours on Day 1. One baseline pharmacokinetics (PK) sample will be taken prior to the dose, and then afterwards for over a 12 hour period (16 samples)

Drug: DexamethasoneDrug: Chronocort: fasted

Interventions

DexamethasoneDRUG

Dexamethasone used to suppress endogenous cortisol secretion

Chronocort : fedChronocort: fastedImmediate release hydrocortisone: fasted
Chronocort: fastedDRUG

single dose of 20mg modified release hydrocortisone in the absence of food

Also known as: modified release hydrocortisone
Chronocort: fasted
Immediate release hydrocortisone: fastedDRUG

single dose of 20mg immediate release hydrocortisone in the absence of food

Also known as: Hydrocortisone
Immediate release hydrocortisone: fasted
Chronocort: fedDRUG

single dose of 20mg modified release hydrocortisone in the presence of food

Also known as: modified release hydrocortisone
Chronocort : fed

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers between 18 and 60 years of age, inclusive (at screening)
  • A body mass index of 21-28 (inclusive).
  • No clinically significant abnormal serum biochemistry, haematology and urine examination values
  • A negative urinary drugs of abuse screen. A positive alcohol test may be repeated at the discretion of the investigator.
  • Negative Human Immunodeficiency Virus (HIV) and Hepatitis b \& C results
  • No clinically significant abnormalities in 12-lead Electrocardiogram (ECG)
  • No clinically significant deviation outside the normal ranges for blood pressure and pulse measurements
  • Subjects (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use effective contraception methods during the trial and for 3 months after the last dose, for example:
  • Oral contraceptive + condom
  • Intra-uterine device + condom
  • Diaphragm with spermicide + condom
  • Subjects must be available to complete the study
  • Subjects must provide written informed consent to participate in the study

You may not qualify if:

  • A clinically significant history of gastrointestinal disorder likely to influence drug absorption
  • Receipt of regular medication (including high dose vitamins, dietary supplements or herbal remedies)
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction Receipt of any vaccination within the previous one month
  • Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections)
  • Current of previous history of tuberculosis
  • A clinically significant history of previous allergy/sensitivity to hydrocortisone and/or dexamethasone
  • A clinically significant history of family history of psychiatric disorders/illnesses
  • A clinically significant history of drug or alcohol abuse
  • Inability to communicate well with the investigator (ie language problem, poor mental development or impaired cerebral function)
  • Participation in a New Chemical entity clinical study within the previous four months or a marketed drug clinical study within the previous three months
  • Subjects who have consumed more than two units of alcohol pre day within seven days prior to the first dose or have consumed any alcohol within the 48hr period prior to the first dose
  • Donation of greater than or equal to 450ml blood within the previous three months
  • Subjects who smoke or ex-smokers who have smoked within six months prior to first dose
  • Subjects who work shifts (ie regularly alternate between days, afternoons and nights)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexamethasoneHydrocortisone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPregnenedionesPregnenes11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Results Point of Contact

Title
Dr G Sharma
Organization
Simbec Research Ltd
contact@simbec.com
0800 691995

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2015

First Posted

April 3, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 4, 2022

Results First Posted

December 15, 2017

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share