Healthy VolunteersPhase 1NCT03665194
A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart
A Phase 1 study testing Cortexolone 17α-propionate solution in people with Healthy Volunteers, run by Cassiopea SpA at 1 site in United Kingdom.
Trial summary
This is a randomised, double blind placebo controlled Phase I study which will assess the safety, tolerability and PK of Cortexolone 17α-propionate (and its metabolites), and its effects on the QTc interval when administered as multiple doses to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cortexolone 17α-propionate solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2018to 12 Sep 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects ≥18 and ≤40 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
- Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
- Subjects must be bald, have a shaved head, or be willing to have their head shaved.
- Female subjects who are either: (a) Non-childbearing potential, e.g. post-menopausal (as defined as amenorrhoea for at least 12 months with no alternative medical cause) or permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) OR (b) Childbearing potential AND (if heterosexually active) agree to use at least one form of highly effective contraception as defined below, starting at least one menstrual cycle before first study drug administration and continuing until at least 3 months after the end of the systemic exposure of the study drug.
- Highly effective contraceptive methods for females are as follows:
- Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation as follows:
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- Oral
- Intravaginal
- Transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation as follows: o Oral
- Injectable
- Implantable
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Male partner vasectomised (with documented evidence of azoospermia if possible)
- Male subjects, if heterosexually active and with a female partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least three months after the end of the systemic exposure of the study drug. Female partners of male subjects who are of childbearing potential must use one or more forms of highly effective contraception as defined above, starting at least one menstrual cycle before (their male subject's) first study drug administration and continuing until at least three months after the end of their male partner's systemic exposure to the study drug.
- For male subjects who have had a vasectomy (with documented evidence of azoospermia if possible) and agree to use a barrier method (male condom) for the stated time period, no additional contraceptive method is required by their female partner.
- Subjects must agree not to donate sperm or ova from the time of the first administration of study medication until 3 months after the end of the systemic exposure of the study drug.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the investigator.
- Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Who cannot join
- Current or recurrent disease (e.g., cardiovascular, haematological, neurological, endocrine, renal, liver, gastrointestinal, hepatic or other conditions) that could affect the action, absorption, or disposition of Cortexolone 17α-propionate, or could affect clinical assessments or clinical laboratory evaluations.
- Current or relevant history of any physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- Any other significant disease or disorder which, in the opinion of the investigator, may put the subject at unacceptable risk because of participation in the study, may influence the result of the study, or may affect the subject's ability to participate in the study.
- History of any pathology affecting the skin such as eczema, psoriasis or any skin hypersensitivity.
- Have tattoos on the scalp or thigh which would affect the area for topical application of the trial drug.
- The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise related clinically significant cardiac events.
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- Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following (at screening, Day -1 or pre-dose of Day 1):
- Sinus node dysfunction.
- Clinically significant PR (PQ) interval prolongation.
- Intermittent second or third degree AV block.
- Complete bundle branch block.
- Sustained cardiac arrhythmia's including (but not limited to) atrial fibrillation or supraventricular tachycardia; any symptomatic arrhythmia with the exception of isolated extra systoles.
- More than 200 ventricular ectopic beats in 24 hours.
- Ventricular tachycardia (ventricular tachycardia defined as ≥ 3 successive ventricular ectopic beats at a rate of > 120 bpm).
- Abnormal T wave morphology.
- QT interval corrected using the Fridericia's formula (QTcF) > 450 ms.
- Any other ECG abnormalities in the standard 12-lead ECG and 24-hour 12 lead Holter ECG or an equivalent assessment which in the opinion of the investigator will interfere with the ECG analysis.
- Subjects with borderline abnormalities may be included if the deviations do not pose a safety risk, and if agreed between the appointed Cardiologist and the investigator.
- Has vital signs outside of the following normal range at screening, Day -1 or Day 1 predose:
- Blood pressure (BP):
- Supine BP (after at least 5 minutes of supine rest):
- Systolic blood pressure: 90 - 140 mmHg.
- Diastolic blood pressure: 40 - 90 mmHg.
- Supine pulse rate after at least 5 minutes of rest: 45 - 100 bpm .
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;
- Subjects who are pregnant, breast feeding or lactating.
- Any clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel, coagulation and urinalysis), and vital signs, or physical findings at screening, pre-dose of Day 1 (as judged by the investigator). In case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- Positive test results for alcohol or drugs of abuse at screening or Day -1.
- Presence or history of drug or alcohol abuse in the last 5 years, or the inability to refrain from alcohol use from 48 hours before screening, dosing and each scheduled visit until the end of the study. Alcohol abuse is defined as regular weekly intake of more than 14 units, using the following NHS alcohol tracker http://www.nhs.uk/Tools/Pages/drinks-tracker.aspx.
- Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, electronic cigarettes) within 3 months prior to the planned first day of dosing.
- Use of prescription medications within 14 days or 10 half-lives (whichever is longer) prior to Day 1 of the dosing period, or any over-the-counter (OTC) medication (including multivitamin, herbal, or homeopathic preparations, excluding hormonal contraception, hormone-replacement therapy, and/or an occasional dose of acetaminophen) within 7 days prior to Day 1 of the dosing period.
- Consumption of herbal remedies or dietary supplements containing St. John's Wort in the three weeks before the planned Day 1 of the dosing period.
- Consumption of drugs or other substances known to be potent inhibitors or inducers of CYP P450s in the three weeks before the planned Day 1 of the dosing period. This includes food or drink products containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits).
- Consumption of caffeine, caffeine-containing or xanthine-containing products, energy drinks containing taurine or glucuronolactone within 48 hours prior to the planned first study drug administration.
- Has received an investigational product or been treated with an investigational device within 90 days prior to first drug administration and will not start any other investigational product or device study within 90 days after last study drug administration.
- Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound or any of the stated ingredients.
- History of significant allergic reaction (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
- Has donated or lost 400 mL blood or more within the last 16 weeks preceding the first day of dosing.
- Has a mental incapacity or language barriers precluding adequate understanding, co-operation, and compliance with the study requirements.
- Cassiopea S.p.A. CONFIDENTIAL 30 April 2018 Protocol Ref: CB-03-01/33 Final Version 5.0 Page 30 of 43 RPL Study No. C16021 C16021Protocolv5.030Apr2018
- An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
- Prior screen failure (where the cause of the screen failure is not deemed to be temporary), randomization, participation, or enrolment in this study. Subjects who initially failed due to temporary non-medically significant issues are eligible for re-screening once the cause has resolved.
- Objection by the General Practitioner (GP) to the subject entering the study.
- Subjects with any medical history, conditions, or risks that, in the opinion of the investigator, may interfere with the subject's full participation in the study or compliance with the protocol, or may pose any additional risk for the subject or confound the assessment of the subject or outcome of the study.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Effects of Systemically Absorbed Cortexolone 17α-propionate (and Its Metabolites) on QT Interval Following Repeat Topical Administration in Healthy Volunteers
This is a randomised, double blind placebo controlled Phase I study which will assess the safety, tolerability and PK of Cortexolone 17α-propionate (and its metabolites), and its effects on the QTc interval when administered as multiple doses to healthy adult volunteers. Volunteers will receive a morning and evening dose (12 hours apart) of 225 mg (3 mL Cortexolone 17α-propionate applied topically as a 7.5 % solution (75 mg in 1 mL), giving a total daily dose of 450 mg (6 mL) per individual.
Read the detailed description
Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will be dosed in four groups of eight (purely for logistical reasons relating to the procedure times expected with dosing and ECG). Volunteers will receive either the active drug or matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive the active drug and two will receive matching placebo.
Volunteers will be screened within 20 days prior to entering the study on Day -1. Each volunteer will receive verbal and written information followed by signing of the ICF prior to any screening procedures taking place. Volunteers will be admitted to the study unit on Day -1, dosed twice daily on Days 1-3 and once on Day 4 (morning dose only). They will be discharged on Day 6 and will have a telephone follow-up on Day 14. If they report any relevant Adverse Event (AE) they will be invited to attend the unit for an outpatient visit as close to Day 14 as is possible.
- Conditions
- Healthy Volunteers
- Being tested
- Cortexolone 17α-propionate solution, Placebo
- Keywords
- QT/QTc Interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortexolone 17α-propionate solutionDrug
Single topical application to be applied twice daily (0 hour and 12 hour) on Days 1-3 and Once Daily (0 hour) on Day 4.
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cortexolone 17α-propionate 7.5% solution | Experimental | Not described Receives: Drug: Cortexolone 17α-propionate solution |
| Vehicle solution | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Cmax: Maximum observed plasma concentration Days 1 and 4
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
tmax: Time of maximum observed plasma concentration
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
t½: Apparent plasma terminal elimination half-life
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
AUC0-24h: Area under the plasma concentration-time curve from time zero to 24 hours, calculated by the linear/log trapezoidal rule
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
AUC0-t: Area under the plasma concentration-time curve from time zero up to the last quantifiable concentration
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
AUC0-inf: Area under the plasma concentration-time curve from time zero to infinity
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
CL: Blood clearance
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
λz: Terminal elimination rate constant
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
CLr: Renal clearance
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Vz: Volume of distribution
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
MRT: Mean residence time
Measured: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
QT interval changes
QT intervals will be assessed using triplicate 12-lead ECGs electronically recorded at each time point and evaluated by a blinded select cardiologist
Measured: Day1 (each hour starting from 2 till 12 hours post IMP administration), Day 4 (each hour starting from 2 till 12 hours post IMP administration), Day 5 (24 hs post last IMP administration) and Day 6 (48 hs post last IMP administration).
Secondary outcomes (5)
Incidence of treatment-emergent adverse event
Measured: Day1, 2, 3, 4, 5, 6 and 14
Proportion of subjects with skin reaction
Skin reactions at the site of application will be assessed using a standardised in-house method. Any pain will be assessed using a Visual Analogue Scale (O-10).
Measured: Day1, 2, 3, 4, 5, 6 and 14 (if applicable)
Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)
Measured: Haematology, chemistry and coagulation: Day-1/1, 3, 5 and 14. Urinalysis: Day-1 and Day 14
Proportion of subjects with abnormalities on electrocardiogram (ECG)
Measured: Day1, 4, 6 and 14
Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate and temperature)
Measured: Day1, 2, 3, 4, 5 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start6 Jun 2018
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will be dosed in four groups of eight (purely for logistical reasons relating to the procedure times expected with dosing and ECG). Volunteers will receive either the active drug or matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive the active drug and two will receive matching placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cassiopea SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorg Taubel, MD FFPM, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665194
- Sponsor's protocol ID
- CB-03-01/33
- Status last verified
- Feb 2019
- First submitted
- 18 Jun 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Effects of Systemically Absorbed Cortexolone 17α-propionate (and Its Metabolites) on QT Interval Following Repeat Topical Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03665194
- Acronym / sponsor ID
- CB-03-01/33
- Conditions
- Healthy Volunteers
- Keywords
- QT/QTc Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cassiopea SpAIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 11 Sep 2018 (actual)
- 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 is a randomised, double blind placebo controlled Phase I study which will assess the safety, tolerability and PK of Cortexolone 17α-propionate (and its metabolites), and its effects on the QTc interval when administered as multiple doses to healthy adult volunteers. Volunteers will receive a morning and evening dose (12 hours apart) of 225 mg (3 mL Cortexolone 17α-propionate applied topically as a 7.5 % solution (75 mg in 1 mL), giving a total daily dose of 450 mg (6 mL) per individual.
Detailed description
Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will be dosed in four groups of eight (purely for logistical reasons relating to the procedure times expected with dosing and ECG). Volunteers will receive either the active drug or matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive the active drug and two will receive matching placebo.
Volunteers will be screened within 20 days prior to entering the study on Day -1. Each volunteer will receive verbal and written information followed by signing of the ICF prior to any screening procedures taking place. Volunteers will be admitted to the study unit on Day -1, dosed twice daily on Days 1-3 and once on Day 4 (morning dose only). They will be discharged on Day 6 and will have a telephone follow-up on Day 14. If they report any relevant Adverse Event (AE) they will be invited to attend the unit for an outpatient visit as close to Day 14 as is possible.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Thirty-two volunteers will be enrolled and evaluated (i.e. complete the study). Subjects will be dosed in four groups of eight (purely for logistical reasons relating to the procedure times expected with dosing and ECG). Volunteers will receive either the active drug or matching placebo in a 3:1 ratio. Therefore within each cohort, six volunteers will receive the active drug and two will receive matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Cortexolone 17α-propionate 7.5% solution | Experimental | Drug: Cortexolone 17α-propionate solution |
| Vehicle solution | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Male or female subjects ≥18 and ≤40 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
- Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
- Subjects must be bald, have a shaved head, or be willing to have their head shaved.
- Female subjects who are either: (a) Non-childbearing potential, e.g. post-menopausal (as defined as amenorrhoea for at least 12 months with no alternative medical cause) or permanently sterile (permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) OR (b) Childbearing potential AND (if heterosexually active) agree to use at least one form of highly effective contraception as defined below, starting at least one menstrual cycle before first study drug administration and continuing until at least 3 months after the end of the systemic exposure of the study drug.
- Male subjects, if heterosexually active and with a female partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least three months after the end of the systemic exposure of the study drug. Female partners of male subjects who are of childbearing potential must use one or more forms of highly effective contraception as defined above, starting at least one menstrual cycle before (their male subject's) first study drug administration and continuing until at least three months after the end of their male partner's systemic exposure to the study drug.
Key exclusion criteria (45 listed)
- Current or recurrent disease (e.g., cardiovascular, haematological, neurological, endocrine, renal, liver, gastrointestinal, hepatic or other conditions) that could affect the action, absorption, or disposition of Cortexolone 17α-propionate, or could affect clinical assessments or clinical laboratory evaluations.
- Current or relevant history of any physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- Any other significant disease or disorder which, in the opinion of the investigator, may put the subject at unacceptable risk because of participation in the study, may influence the result of the study, or may affect the subject's ability to participate in the study.
- History of any pathology affecting the skin such as eczema, psoriasis or any skin hypersensitivity.
- Have tattoos on the scalp or thigh which would affect the area for topical application of the trial drug.
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 |
|---|---|---|
| Cortexolone 17α-propionate solutionSingle topical application to be applied twice daily (0 hour and 12 hour) on Days 1-3 and Once Daily (0 hour) on Day 4. | Drug | Cortexolone 17α-propionate 7.5% solution |
| Placebomatching placebo | Drug | Vehicle solution |
Primary outcome
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
Cmax: Maximum observed plasma concentration Days 1 and 4
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
tmax: Time of maximum observed plasma concentration
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
t½: Apparent plasma terminal elimination half-life
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
AUC0-24h: Area under the plasma concentration-time curve from time zero to 24 hours, calculated by the linear/log trapezoidal rule
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
AUC0-t: Area under the plasma concentration-time curve from time zero up to the last quantifiable concentration
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
AUC0-inf: Area under the plasma concentration-time curve from time zero to infinity
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
CL: Blood clearance
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
λz: Terminal elimination rate constant
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
CLr: Renal clearance
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
Vz: Volume of distribution
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2)
Time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.
MRT: Mean residence time
QT interval changes
Time frame: Day1 (each hour starting from 2 till 12 hours post IMP administration), Day 4 (each hour starting from 2 till 12 hours post IMP administration), Day 5 (24 hs post last IMP administration) and Day 6 (48 hs post last IMP administration).
QT intervals will be assessed using triplicate 12-lead ECGs electronically recorded at each time point and evaluated by a blinded select cardiologist
5 secondary outcomes
Incidence of treatment-emergent adverse event
Time frame: Day1, 2, 3, 4, 5, 6 and 14
Proportion of subjects with skin reaction
Time frame: Day1, 2, 3, 4, 5, 6 and 14 (if applicable)
Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)
Time frame: Haematology, chemistry and coagulation: Day-1/1, 3, 5 and 14. Urinalysis: Day-1 and Day 14
Proportion of subjects with abnormalities on electrocardiogram (ECG)
Time frame: Day1, 4, 6 and 14
Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate and temperature)
Time frame: Day1, 2, 3, 4, 5 and 14
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 4 Feb 2019.
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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.
Jorg Taubel, MD FFPM principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cortexolone 17α-propionate solution in people with Healthy Volunteers, run by Cassiopea SpA at 1 site in United Kingdom.
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 22 inclusion and 45 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
PK parameters of Cortexolone 17α-propionate and the two main metabolites Cortexolone 21-propionate (M1) and Cortexolone (M2) (time frame: Samples will be collected 1hour pre IMP administration and at 2, 3, 4, 5, 6, 7, 8, 9, 10,12 hours post IMP administration on Day1 and Day4. Further samples will be collected at 24 hours (Day 5) and 48 hours (Day 6) after the final dose on Day 4.). The study lists 12 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 4 Feb 2019.