A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally

Launched by BAYER · Sep 28, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent.
• • Moderate or severe renal impairment as assessed by estimated glomerular filtration rate (eGFR) based on serum creatinine collected 2 to 10 days prior to dosing and calculated according to a modified Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m\^2 (inclusive); Severely impaired renal function: eGFR \< 30 mL/min/ 1.73 m\^2 (including at least 50% patients requiring hemodialysis).
• • Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening.
• • Normal renal function, as assessed by eGFR based on serum creatinine at screening according to the modified CKD-EPI formula: eGFR ≥90 mL/min/1.73 m\^2.
• • Body mass index (BMI) within the range 18 - 32 kg/m\^2 (inclusive).
• • Male or female.
• • Study participants of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period from signing of the informed consent form (ICF) until the follow-up visit on Day 6. Use of adequate contraception should be consistent with local regulations.
• Exclusion Criteria:
• • Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (with vomiting, diarrhea, constipation, etc.) requiring medical treatment.
• • Acute renal failure or acute nephritis within the past 2 years.
• • Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin.
• • Conditions associated with a risk of hypersensitivity reactions with study intervention (active substances, or excipients of the preparations) as judged by the investigator.
• • Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention.
• • Use of drugs which may affect absorption (e.g. loperamide, metoclopramide),and systemic administration of any broad-spectrum antibiotic within 1 week before study drug administration, unless the drug is part of the mandatory dosing regimen for treatment of renal impairment or related conditions.
• • Use of drugs which may affect absorption by increasing the gastro-intestinal pH e.g. proton pump inhibitors from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration.
• • Use of anti-coagulant drugs other than 100 mg acetylsalicylic acid per day.
• • Major change of any medication regimen less than 2 weeks prior to first study drug administration, including dose adjustments.
• • Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention
• • Women of childbearing potential with a positive pregnancy test at screening or on Day -1.