Hepatic ImpairmentPhase 1NCT06126575
A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
A Phase 1 study testing Elacestrant dihydrochloride in people with Hepatic Impairment, run by Stemline Therapeutics, Inc. at 3 sites in United States.
Trial summary
This is a Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Elacestrant dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Mar 2023to 11 Nov 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol restrictions and requirements.
- Males and Females older than 18 years.
- Body mass index between 18.0 and 40.0 kg/m^2, inclusive.
- Females must have non-functioning ovaries defined as postmenopausal and/or bilateral salpingo - oophorectomy. All female subjects must have a negative pregnancy test at screening and at check-in.
- Males who are non-sterilized and sexually active with a female partner of childbearing potential must agree to use highly effective contraception from admission and for 120 days after IMP dose.
- Males must agree not to donate sperm from admission and for 120 days after investigational medicinal product dose.
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- Non-smoker or light smoker, i.e. no more than 10 cigarettes or 10 mg equivalent use of Nicotine per day by e-vapor cigarette, pipe, cigar, chewing tobacco, nicotine patch, nicotine gum, AND able or willing to refrain from smoking and tobacco use for 2 hours prior to dose and 4 hours after IMP dose.
- Additional inclusion criteria applicable to subjects with Normal Hepatic Function Only
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations. NOTE: Congenital nonhemolytic hyperbilirubinemia/Gilbert's syndrome based on total and direct bilirubin is not acceptable.
- Matched to subjects with severe hepatic impairment in gender, age (±10 years), weight (±10 kg) and race.
- Additional inclusion criteria applicable to subjects with Severe Hepatic Impairment Only
- Documented chronic stable severe liver disease according to Child Pugh (CP) classification (CP score C) with diagnosis of hepatic impairment due to parenchymal liver disease. This will exclude biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder.
- 'Documented' is defined by medical history and physical examination, and confirmed by at least 1 of the following: hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging, and/or liver biopsy.
- 'Chronic' is defined as >6 months.
- 'Stable' is defined as no clinically significant change in disease status within the last 6 weeks, as documented by the subject's recent medical history (eg, no worsening of clinical signs of hepatic impairment, or no worsening of total bilirubin or prothrombin time by more than 50%).
- Subjects with severe hepatic impairment may have medical findings consistent with their hepatic dysfunction as determined by medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and check-in (Day -1), as assessed by the Investigator, provided that the followings are satisfied:
- Non-hepatic impairment-related, abnormal clinical laboratory evaluations must not be clinically relevant, as judged by the Investigator and approved by the study assigned medical monitor.
- Values outside the normal ranges for liver function tests are acceptable as consistent with the subject's hepatic condition, provided they are stable for at least 1 month prior to screening, as judged by the Investigator and approved by the study assigned medical monitor.
- Subjects may enter with non-clinically significant Grade 1 anemia per CTCAE version 5.0, i.e. with Hb > 10 mg/dL.
- Subjects must have a platelet count ≥ 35 × 109 /L
- Subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, hypertension or hyperlipidaemia, etc. may be included. Subjects with diabetes mellitus may be included, provided the subjects have:
- Glycosylated hemoglobin A1c values ≤ 9.5% at screening; eligibility in case of outside values should be evaluated by the study assigned medical monitor on a case-by-case basis.
- Blood glucose values ≤ 240 mg/dL at screening and check-in (Day -1) while on subjects' normal diabetes medication.
- Currently on a stable medication regimen, defined as not starting new drug(s) or changing drug dose(s) within 28 days of administration of study drug (Day 1). Concomitant medications administered within 28 days prior to administration of study drug (Day 1) must be approved by the Investigator and the study assigned medical monitor.
Who cannot join
- Presence of any condition or circumstance that prevents the subject from understanding and signing the ICF.
- Presence or history of any disorder that may prevent the successful completion of the study.
- History of significant hypersensitivity, intolerance, or allergy to food, or any medical product or relevant excipient, unless approved by the Investigator.
- History of allergy to Elacestrant or drugs in a similar pharmacology class (selective ER modulator or SERD) or excipients used in the formulations of these drugs.
- History of stomach or intestinal surgery or resection, or any significant gastrointestinal disease (eg, Crohn's disease) that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy will be allowed at the discretion of the Investigator.
- Acute disease state (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to check-in.
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- History of drug/chemical abuse within 1 year prior to check-in.
- History of alcohol abuse within 3 months prior to screening and/or consume > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1 1⁄2 oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive drug screen at screening, or positive alcohol or drug screen at check-in.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) or device in the past 28 days or 5 half-lives (whichever is longer) prior to dosing.
- Received Elacestrant within 60 days prior to dosing.
- Corrected value of the interval between the Q and T waves on the ECG tracing, using Fridericia's formula, is > 450 ms (for healthy males) or > 470 ms (for healthy females), is > 470 ms (for hepatic impairment males) or > 480 ms (for hepatic impairment females); or has ECG findings deemed abnormal with clinical significance by the Investigator at screening. ECGs will be collected in triplicate.
- Use of any drugs or herbal remedies known to be strong or moderate inhibitors or inducers of CYP3A enzymes for 28 days prior to dosing or 5 half-lives (whichever is longer) and throughout the study.
- Not willing to follow on-study diet requirements.
- Ingestion of Seville orange- or grapefruit- containing foods or beverages within 28 days prior to check-in.
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Subjects who, in the opinion of the Investigator, should not participate in this study.
- Additional exclusion criteria applicable to Subjects with Normal Hepatic Function Only
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal, neurological, or psychiatric disorder.
- Unable to refrain from or anticipate the use of any non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to dosing and throughout the study.
- NOTE: After check-in, acetaminophen (up to 2 g per 24 hours), and 1% hydrocortisone cream may be administered at the discretion of the Investigator.
- Unable to refrain from or anticipate the use of any prescription medications within 28 days prior to dosing or 5 half-lives (whichever is longer) and throughout the study, unless approved by the Investigator and the study assigned medical monitor.
- NOTE: slow-release medications / products considered to still be active prior to check-in must be approved by the Investigator and the study assigned medical monitor.
- Positive hepatitis B panel test and/or positive hepatitis C RNA test. Subjects whose results are compatible with prior immunization may be included.
- History of diabetes mellitus.
- Additional exclusion criteria applicable to Subjects with Hepatic Impairment Only
- Grade 3 and Grade 4 encephalopathy as determined by the CP score.
- Portal systemic shunt.
- Subject has shown evidence of hepatorenal syndrome or abnormal serum creatinine levels (above upper limit for the local lab) and estimated glomerular filtration rate < 60 mL/min or abnormal sodium and potassium levels. The determination of the severity and clinical relevance of the latter 2 abnormalities will be at the discretion of the Investigator.
- Treatment for gastrointestinal bleeding within the 3 months prior to check-in.
- New medication or a change in dose for hepatic encephalopathy within the 3 months prior to check-in, unless approved by the Investigator and the study assigned medical monitor.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Floridian Clinical Research
Miami, Florida, 33016
American Research Corp
San Antonio, Texas, 78215
Inland Empire Clinical Trials, LLC
Yucaipa, California, 92399
About this study
Official title: A Phase 1, Open-Label, Non-randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of 200 mg Elacestrant in Subjects With Normal Hepatic Function or Severe Hepatic Impairment
This is a Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant.
Read the detailed description
A total of 16 subjects will be recruited and divided between the following two Groups:
Group 1: 8 subjects with severe hepatic impairment Group 2: 8 subjects with normal hepatic function (control group)
On Day 1, subjects will receive a single oral dose of 200 mg Elacestrant (2 x 100 mg tablets). Safety assessment and blood sampling for Elacestrant analysis on plasma will be performed at predefined time points up to 240 hours post.
The total duration of study participation for each subject (from screening to the follow up call) is anticipated to be approximately 6 weeks.
- Conditions
- Hepatic Impairment
- Being tested
- Elacestrant dihydrochloride
- Keywords
- metastatic breast cancer, breast cancer, elacestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elacestrant dihydrochlorideDrug
A single oral dose of 200 mg elacestrant (2 x 100 mg tablets).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with normal hepatic function | Experimental | Subjects with normal hepatic function will receive treatment compared to subjects with severe hepatic function Receives: Drug: Elacestrant dihydrochloride |
| Subjects with severe hepatic impaired function | Experimental | Subjects with severe hepatic function will receive treatment compared to subjects with normal hepatic function Receives: Drug: Elacestrant dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Predose 240 hours after drug administration
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Measured: Predose 240 hours after drug administration
AUC from time zero to infinity (AUC0-∞)
Measured: Predose 240 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start13 Mar 2023
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126575
- Sponsor's protocol ID
- STML-ELA-1023
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Non-randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of 200 mg Elacestrant in Subjects With Normal Hepatic Function or Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06126575
- Acronym / sponsor ID
- STML-ELA-1023
- Conditions
- Hepatic Impairment
- Keywords
- metastatic breast cancer, breast cancer, elacestrant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 13 Nov 2023 (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 Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant.
Detailed description
A total of 16 subjects will be recruited and divided between the following two Groups:
Group 1: 8 subjects with severe hepatic impairment Group 2: 8 subjects with normal hepatic function (control group)
On Day 1, subjects will receive a single oral dose of 200 mg Elacestrant (2 x 100 mg tablets). Safety assessment and blood sampling for Elacestrant analysis on plasma will be performed at predefined time points up to 240 hours post.
The total duration of study participation for each subject (from screening to the follow up call) is anticipated to be approximately 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with normal hepatic function | Experimental | Drug: Elacestrant dihydrochlorideSubjects with normal hepatic function will receive treatment compared to subjects with severe hepatic function |
| Subjects with severe hepatic impaired function | Experimental | Drug: Elacestrant dihydrochlorideSubjects with severe hepatic function will receive treatment compared to subjects with normal hepatic function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol restrictions and requirements.
- Males and Females older than 18 years.
- Body mass index between 18.0 and 40.0 kg/m^2, inclusive.
- Females must have non-functioning ovaries defined as postmenopausal and/or bilateral salpingo - oophorectomy. All female subjects must have a negative pregnancy test at screening and at check-in.
- Males who are non-sterilized and sexually active with a female partner of childbearing potential must agree to use highly effective contraception from admission and for 120 days after IMP dose.
Key exclusion criteria (33 listed)
- Presence of any condition or circumstance that prevents the subject from understanding and signing the ICF.
- Presence or history of any disorder that may prevent the successful completion of the study.
- History of significant hypersensitivity, intolerance, or allergy to food, or any medical product or relevant excipient, unless approved by the Investigator.
- History of allergy to Elacestrant or drugs in a similar pharmacology class (selective ER modulator or SERD) or excipients used in the formulations of these drugs.
- History of stomach or intestinal surgery or resection, or any significant gastrointestinal disease (eg, Crohn's disease) that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). Cholecystectomy will be allowed at the discretion of the Investigator.
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 |
|---|---|---|
| Elacestrant dihydrochlorideA single oral dose of 200 mg elacestrant (2 x 100 mg tablets). | Drug | Subjects with normal hepatic function, Subjects with severe hepatic impaired function |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Predose 240 hours after drug administration
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Time frame: Predose 240 hours after drug administration
AUC from time zero to infinity (AUC0-∞)
Time frame: Predose 240 hours after drug administration
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 19 Nov 2024.
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Hepatic Impairment
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Elacestrant dihydrochloride in people with Hepatic Impairment, run by Stemline Therapeutics, Inc. at 3 sites in United States.
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 24 inclusion and 33 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
Maximum observed plasma concentration (Cmax) (time frame: Predose 240 hours after drug administration). The study lists 3 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 19 Nov 2024.