Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone

NCT02777268 | Completed Phase 1 Results

• 1 other identifier: Infacort 001
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a single centre, open-label, randomised, 5-way crossover study.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone

  To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.

  -1h, -0.5h, 0h, 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

• Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone

  To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.

  -1h, -0.5h, 0h, 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

• Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone

  To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.

  -1h, -0.5h, 0h, 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

Secondary Outcomes (4)

• Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg

  -1h, -0.5h, 0h, 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

• Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg

  -1h, -0.5h, 0h, 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

• Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg

  1 day

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.

  1 day

Study Arms (5)

Infacort 0.5 mg

EXPERIMENTAL

Multi-particulate granules from 1 (0.5 mg) capsule

Drug: Infacort

Infacort 2 mg

EXPERIMENTAL

Multi-particulate granules from 1 (2 mg) capsule

Drug: Infacort

Infacort 5 mg

EXPERIMENTAL

Multi-particulate granules from 1 (5 mg) capsule

Drug: Infacort

Infacort 10 mg

EXPERIMENTAL

Multi-particulate granules from 1 (10 mg) capsule

Drug: Infacort

Hydrocortisone

ACTIVE COMPARATOR

1 (10 mg) tablet

Drug: Hydrocortisone

Interventions

Infacort DRUG

Multi-particulate granules

Infacort 0.5 mg; Infacort 10 mg; Infacort 2 mg; Infacort 5 mg

Hydrocortisone DRUG

Tablet

Hydrocortisone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers between 18 and 60 years of age, inclusive (at Screening Visit).
• Subjects with a Body Mass Index (BMI) of 21-28.
• Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).
• Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.
• Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
• Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP.
• 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 was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom.
• Subjects were available to complete the study.
• Subjects satisfied a medical examiner about their fitness to participate in the study.
• Subjects provided 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 within 14 days prior to the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).
• Receipt of any vaccination within 14 days prior to the first dose of IMP.
• 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).
• Participated 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 was 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 had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP.
• Donation of 450 mL or more of blood within the previous 3 months.
• Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP).
• Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).

Sponsors & Collaborators

• Neurocrine UK Limited: lead
• Simbec Research: collaborator

MeSH Terms

Interventions

Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Dr Girish Sharma
• Organization: Simbec Research Limited

+44 1443 690977

Study Officials

• Girish Sharma, MD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: April 27, 2016
• First Posted: May 19, 2016
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 2, 2017
• Results First Posted: August 10, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share