Randomized, Open Label, Crossover Study Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Administered as a Suppository With the Sephure® Rectal Suppository Applicator Compared With Cortenema in Healthy Subjects

Cristcot LLC0 sites16 target enrollmentMarch 2016

ConditionsHealthy

InterventionsCortenema Hydrocortisone Acetate

Overview

Phase: Phase 1
Intervention: Cortenema
Conditions: Healthy
Sponsor: Cristcot LLC
Enrollment: 16
Primary Endpoint: primary PK endpoints
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will be an open label, single dose, randomized, 2 way (2 period) crossover study in healthy adult subjects at a single study center.

Detailed Description

This study will be an open label, single dose, randomized, 2 way (2 period) crossover study in healthy adult subjects at a single study center. Screening evaluations will occur from Day 28 to Day 2 and subjects will be confined to the clinical research unit (CRU) from Day 1 to Day 2 for each treatment period. The treatment periods will be separated by at least a 7 day washout period. Subjects meeting the study enrollment criteria will be randomly assigned to 1 of 2 sequences (AB or BA) on Day 1 of Treatment Period 1 and will receive either the reference product (A) or the treatment product (B) once during the study

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

May 24, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Cristcot LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects between 18 to 45 years of age, inclusive, at the time of Screening.
•Female subjects must be:
•Of non childbearing potential (surgically sterile \[hysterectomy, oophorectomy or bilateral tubal ligation\] or post-menopausal \>1 year with follicle stimulating hormone \[FSH\] \> 40 U/L), or Non pregnant, non lactating females of childbearing potential who are able and willing to undertake adequate measures to prevent a pregnancy including the use of any medically acceptable forms of birth control by the subject or partner (hormonal birth control, abstinence, diaphragm with spermicide, condom with spermicide, intrauterine device, vasectomy or surgical sterilization) from Screening until the End of Study.
•Male subjects must be able and willing to undertake adequate measures to prevent a pregnancy throughout the study including the use of any medically acceptable forms of birth control by the subject or partner (hormonal birth control, abstinence, diaphragm with spermicide, condom with spermicide, intrauterine device, vasectomy, surgical sterilization or post menopausal partner) from Screening until the End of Study.
•Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at the time of Screening.
•Subject is willing and able to provide informed consent.
•Subject is willing and able to be confined to the CRU and adhere to the study and lifestyle restrictions.

Exclusion Criteria

•History of clinically significant illness or surgery as determined by the Principal Investigator or designee, within 5 years prior to the first IMP administration.
•History or evidence of any clinically significant pathology including neurological, cardiovascular, endocrine, pulmonary, gastrointestinal, renal, hepatic, hematological, immunological, psychiatric or metabolic disorder(s) as determined by the Principal Investigator or designee.
•Any significant rectal pathology that, in the opinion of the Principal Investigator or designee, would be a contraindication (or warning) with a hydrocortisone acetate suppository or hydrocortisone retention enema including rectal obstruction, abscess, perforation, active fungal infection(s) and/or bacterial infection(s).
•Subject has had anal sex, cosmetic anal bleaching or perianal waxing within 30 days prior to the first IMP administration.
•History of constipation, diarrhea or frequent bowel movements per day within 30 days prior to the first IMP administration.
•Any clinically significant abnormality (including clinically significant laboratory test result\[s\]) found at Screening or febrile illness or infection within 7 days prior to Screening through Admission (Day 1 of Treatment Period 1) to the CRU.
•Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), or human immunodeficiency virus (HIV) antibody at Screening.
•Clinically significant electrocardiogram (ECG) abnormality at Screening, as determined by the Principal Investigator or designee.
•Positive pregnancy test (females only) at Screening or Admission (Day 1 of Treatment Periods 1 or 2) to the CRU.
•Subject has history of alcohol abuse or of significant regular alcohol use within 1 year prior to Screening, defined as exceeding 14 units of alcohol per week, where, 1 unit = 12 ounces of beer, 5 ounces of wine or 1.5 ounces of hard liquor.