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Trial · Interventional

CompletedPhase 1Results postedRegistry data

An Investigational Study of Hydrocortisone

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 1
Enrollment
14 participants (actual)
Sponsor
Neurocrine UK Limited · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United Kingdom

Start
Oct 2013
Primary completion
Nov 2014
Completion
Nov 2014
First posted
10 Oct 2013 (estimated)
Last update posted
2 Oct 2026
Conditions
Adrenal Insufficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

    An Investigational Study of Hydrocortisone

    NCT01960530

    Oct 2013 to Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection. The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.

Interventions

  • Hydrocortisone granulesDrug
  • Hydrocortisone TabletDrug
  • i.v. Hydrocortisone InjectionDrug
  • DexamethasoneOther

Arms5

  • No intervention

    Endogenous Cortisol

    No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

  • Other

    Dexamethasone

    1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Dexamethasone is considered a challenge agent and therefore a non-IMP

  • Experimental

    Infacort®

    20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous adrenocorticotropic Hormone (ACTH) and cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

  • Active comparator

    Hydrocortisone Tablet

    20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

  • Active comparator

    i.v Hydrocortisone Injection

    20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Maximum Serum Concentration (Cmax)

    Time frame · Hourly from 0 to 24 hours

    Registry description

    Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)

  2. AUC0-t

    Time frame · Hourly from 0 to 24 hours

    Registry description

    Derived PK for Serum Cortisol: Area under the curve from 0-24 hours

Secondary outcomes(4)
  1. Adverse Events (AEs)

    Time frame · Days 1-2 during each Study Period

    Registry description

    Number of subjects with adverse events throughout the study.

  2. Concentrations of Cortisol Binding Protein

    Time frame · Blood samples on Day 1 and/or Day 2 of each Study Period

    Registry description

    Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.

  3. Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.

    Time frame · Blood samples on Day 1 and/or Day 2 of each Study Period

    Registry description

    A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.

  4. PK and Metabolism of Cortisol

    Time frame · Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period

    Registry description

    Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Hourly from 0 to 24 hours

Maximum Serum Concentration (Cmax)

GroupValue (nmol/L)Spread
Infacort®940.012283.773
Hydrocortisone Tablet896.489258.083
i.v Hydrocortisone Injection1563.479491.267
Primary outcomeGeometric mean· Hourly from 0 to 24 hours

AUC0-t

GroupValue (nmol*h/L)Spread
Infacort®2543.24713.76
Hydrocortisone Tablet2896.73850.31
i.v Hydrocortisone Injection2923.46971.41
Secondary and other outcome results(4)
Secondary outcomeNumber· Days 1-2 during each Study Period

Adverse Events (AEs)

GroupValue (participants)
Endogenous Cortisol3
Dexamethasone3
Infacort®0
Hydrocortisone Tablet1
i.v Hydrocortisone Injection2
Secondary outcomeMean· Blood samples on Day 1 and/or Day 2 of each Study Period

Concentrations of Cortisol Binding Protein

GroupValue (ug/mL)Spread
Endogenous Cortisol22.9502.7355
Dexamethasone23.4413.0381
Infacort®22.3862.8753
Hydrocortisone Tablet21.7573.6545
i.v Hydrocortisone Injection21.4823.2047
Secondary outcomeMean· Blood samples on Day 1 and/or Day 2 of each Study Period

Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.

GroupValue (uIU/mL)Spread
Endogenous Cortisol70.52917.975
Dexamethasone80.66840.801
Infacort®77.57532.195
Hydrocortisone Tablet70.65034.983
i.v Hydrocortisone Injection70.12127.140
Secondary outcomeMean· Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period

PK and Metabolism of Cortisol

GroupValue (nmol/L)Spread
Endogenous Cortisol447.35577.005
Dexamethasone19.3499.567
Infacort®963.134283.376
Hydrocortisone Tablet893.077259.730
i.v Hydrocortisone Injection1580.337492.285

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Endogenous CortisolNo Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.–0 / 143 / 14
Dexamethasone1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Dexamethasone–0 / 143 / 14
Infacort®20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Infacort–0 / 140 / 14
Hydrocortisone Tablet20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. Hydrocortisone Tablet–0 / 141 / 14
i.v Hydrocortisone Injection20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points. i.v. Hydrocortisone Injection–0 / 142 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy male volunteers between 18 and 60 years of age, inclusive (at screening). * Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))\*2. * Subjects with no clinically significant abnormal serum biochemistry, haematology and urinalysis values within 14 days prior to Day 1 of Study Period 1. * Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to Day 1 of Study Period 1. A positive alcohol test may be repeated at the discretion of the Investigator. * Subjects with negative HIV and Hepatitis B and C results. * Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to Day 1 of Study Period 1. * Subjects with 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 (IUD) + condom * Diaphragm with spermicide + condom * Subjects must be available to complete the study. * Subjects must satisfy a medical examiner about their fitness to participate in the study. * Subjects must provide written informed consent to participate in the study. Exclusion Criteria: * A clinically significant history of gastrointestinal disorder likely to influence drug absorption. * Receipt of regular medication within 14 days prior to Day 1 of Study Period 1 (including high dose vitamins, dietary supplements or herbal remedies). * Receipt of any vaccination within 14 days prior to Day 1 of Study Period 1. * Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. * Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections). * Current or previous history of tuberculosis. * A clinically significant history of previous allergy / sensitivity to Hydrocortisone and/or Dexamethasone. * A clinically significant history or family history of psychiatric disorders/illnesses. * A clinically significant history of drug or alcohol abuse. * Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function). * Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study) * Subjects who have consumed more than 2 units of alcohol per day within seven (7) days prior to Day 1 of Study Period 1or have consumed any alcohol within the 48 hour period prior to Day 1 of Study Period 1. * Donation of 450ml or more of blood within the previous 3 months. * Subjects who smoke (or ex-smokers who have smoked within 6 months prior to Day 1 of Study Period 1). * Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).

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