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COMPLETEDPHASE1

An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

An Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® Formulations

NCT03019614•Neurocrine UK Limited

View on ClinicalTrials.gov

Summary

This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).

Eligibility

Age

18 - 60 years

Sex

MALE

Healthy Volunteers

Yes

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 urine examination values within 14 days of the start of the study. The parameters measured included those shown in Appendix 3 of the Study Protocol.
•Subjects with a negative urinary drugs of abuse screen (including alcohol), determined within 14 days of the start of the study.
•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 of the start of the study.
•Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
•Subjects and sexual partners must have used effective contraception methods during the trial and for 3 months after the last dose, for example:
•* Oral contraceptive + condom
•* Intra-uterine device (IUD) + condom
+4 more criteria

Exclusion Criteria

•A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
•Receipt of regular medication within 14 days of the first study day (including high dose vitamins, dietary supplements or herbal remedies).
•Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
•A clinically significant history of previous allergy / sensitivity to Hydrocortisone.
•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 16 weeks or a marketed drug clinical study within the previous 12 weeks.
•Subjects who had consumed more than 2 units of alcohol per day within seven (7) days prior to the first dose or had consumed any alcohol within the 48 hour period prior to the first dose.
•Donation of 450ml or more blood within the previous 12 weeks.
•Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).

Key Dates

Start Date

March 1, 2010

Primary Completion Date

April 1, 2010

Completion Date

April 1, 2010

Last Updated

January 12, 2017

Enrollment

ACTUAL participants

Conditions

Congenital Adrenal HyperplasiaAdrenal Insufficiency

Interventions

Hydrocortisone

DRUG

Chronocort

DRUG

Institutional Registry of Rare Diseases

NCT06573723

Rare DiseasesAmyloidosis+24 more

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RECRUITING

Evaluation of Children With Endocrine and Metabolic-Related Conditions

NCT02769975

Adrenal InsufficiencyGrowth Disorder+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone

Inclusion Criteria

Exclusion Criteria

Institutional Registry of Rare Diseases

Evaluation of Children With Endocrine and Metabolic-Related Conditions

Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment

GROWing Up With Rare GENEtic Syndromes

Exercise Capacity, Physical Fitness, and Physical Activity Levels in Children With CAH

A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)