HealthyPhase 1NCT02671058
Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories
A Phase 1 study testing Cortenema and Hydrocortisone Acetate in people with Healthy, run by Cristcot LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cortenema and Hydrocortisone Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 24 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Positive serum alcohol test at Screening or Admission (Day 1 of Treatment Periods 1 or 2) to the CRU.
- History of regular tobacco use or use of nicotine containing products to control tobacco use within the past 6 months prior to Screening.
- Positive urine drug test (including amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates and phencyclidine) at Screening or Admission (Day 1 of Treatment Periods 1 or 2) to the CRU.
- Use of over the counter (OTC) medications (including oral natural health products, vitamin and herbal supplements) within 7 days prior to the first IMP administration until the End of Study or use of prescription medication within 14 days prior to the first IMP administration until the End of Study. By exception, acetaminophen <1000 mg per day, hormonal contraception and hormonal replacement therapy are permitted.
- Known allergy or history of hypersensitivity to hydrocortisone or any of the inert components of either of the formulations being tested.
- Participation in another clinical study within 60 days prior to the first IMP administration. Participation is considered the last dose of IMP from another study.
- Donation or loss of blood (> 100 mL) of either whole blood or plasma within 60 days prior to the first IMP administration.
About this study
Official title: 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
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Cortenema, Hydrocortisone Acetate
- Keywords
- bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CortenemaDrug
Hydrocortisone Administered as a Liquid Enema
Hydrocortisone AcetateDrug
Hydrocortisone Acetate Administered as a Suppository with the Sephure® Rectal Suppository Applicator
| Study group | Role | What they receive |
|---|---|---|
| Cortenema | Active comparator | Hydrocortisone retention enema (Cortenema) administered rectally as a single dose; each dose unit delivers 100 mg of hydrocortisone per 60 mL. Receives: Drug: Cortenema |
| Hydrocortisone acetate | Experimental | Hydrocortisone acetate suppository 90 mg administered rectally as a single dose with the Sephure Rectal Suppository Applicator Receives: Drug: Hydrocortisone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary PK endpoints
Maximum plasma concentration
Measured: at time 0,1, 2 and 24 hours
primary PK endpoints
Area under the concentration-time curve
Measured: at time 0,1, 2 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion24 May 2016
- Study completion24 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristcot LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Marck C Ensign, Study chair, Executive VP Product Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671058
- Sponsor's protocol ID
- CINC-2015-BA
- Status last verified
- Jul 2017
- First submitted
- 21 Jan 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02671058
- Acronym / sponsor ID
- CINC-2015-BA
- Conditions
- Healthy
- Keywords
- bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cristcot LLCIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Mar 2016
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 24 May 2016 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortenema | Active comparator | Drug: CortenemaHydrocortisone retention enema (Cortenema) administered rectally as a single dose; each dose unit delivers 100 mg of hydrocortisone per 60 mL. |
| Hydrocortisone acetate | Experimental | Drug: Hydrocortisone AcetateHydrocortisone acetate suppository 90 mg administered rectally as a single dose with the Sephure Rectal Suppository Applicator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CortenemaHydrocortisone Administered as a Liquid Enema | Drug | Cortenema |
| Hydrocortisone AcetateHydrocortisone Acetate Administered as a Suppository with the Sephure® Rectal Suppository Applicator | Drug | Hydrocortisone acetate |
Primary outcome
primary PK endpoints
Time frame: at time 0,1, 2 and 24 hours
Maximum plasma concentration
primary PK endpoints
Time frame: at time 0,1, 2 and 24 hours
Area under the concentration-time curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marck C Ensign study chair
Executive VP Product Development
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cortenema and Hydrocortisone Acetate in people with Healthy, run by Cristcot LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary PK endpoints (time frame: at time 0,1, 2 and 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.