A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired H… (NCT06126575) | Clinical Trial Compass
CompletedPhase 1
A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
United States16 participantsStarted 2023-03-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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.
✓. 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.
Exclusion criteria
✕. Presence of any condition or circumstance that prevents the subject from understanding and signing the ICF.
What they're measuring
1
Maximum observed plasma concentration (Cmax)
Timeframe: Predose 240 hours after drug administration
2
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Timeframe: Predose 240 hours after drug administration
3
AUC from time zero to infinity (AUC0-∞)
Timeframe: Predose 240 hours after drug administration
✕. 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.
✕. 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.