Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT05515432
Eligibility Criteria:
Inclusion Criteria:
* Participant must be 18 to 82 years of age inclusive, at the time of signing the informed consent.
* Normal kidney function or at different stages of renal impairment (mild to severe renal impairment, ESRD with hemodialysis or hemodiafiltration).
* Race: White (Note: Clinical Data Interchange Standards Consortium \[CDISC\] definition of White: Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White \[FDA\]).
* Body mass index (BMI) within the range 18.0 and 35.0 kg/m\^2 (both inclusive).
* Body weight equal or above 55 kg.
* Male or female participants; women have to be of non-childbearing potential as defined in Section 10.4.1 (e.g., postmenopausal for at least 1 year, women with bilateral salpingectomy, women with bilateral ovariectomy, and women with hysterectomy).
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Men must agree to use a condom in sexual intercourse with female partner of childbearing potential and not to act as sperm donor for 10 days after dosing.
* eGFR \<90 mL/min/1.73 m\^2 alculated by the CKD-EPI formula (eGFR must be repeated if screening period \>10 days before dosing) 21 to 2 days prior to dosing and patients with ESRD on hemodialysis or hemodiafiltration.
* Stable renal function (e.g., a serum creatinine value determined at least 3 months before the screening visit should not vary by more than 25% from the serum creatinine value determined at the screening visit).
* eGFR ≥90 mL/min/1.73 m\^2 calculated by the CKD-EPI formula (eGFR must be repeated if screening period \>10 days before dosing) 21 to 2 days prior to dosing.
* Needs to be within the required matching age, gender, and body weight range.
Exclusion Criteria:
* Women of childbearing potential, pregnant or lactating women.
* Medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator.
* Known or suspected liver disorders (including Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis).
* Known hypersensitivity to the study drugs (active substances or excipients of the preparations).
* Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids), urticaria, or significant non-allergic drug reactions.
* Relevant acute diseases within the last 4 weeks prior to intake of study intervention.
* Febrile illness within 2 weeks before intake of study intervention.
* Known tendency for vasovagal reactions (e.g., after venipuncture) or clinically relevant history of syncope.
* History of gastrointestinal surgery, with the exception of appendectomy unless it had been performed within the previous 12 months before screening.
* Acute diarrhea or constipation within 14 days before intake of study intervention.
* Diagnosed malignancy within the past 5 years with exception of completely resected basal cell cancer of the skin (excision \>6 months before screening).
* Planned intervention or surgery during the study which might impact the study objectives.
* History of clinically relevant bleeding within the past 3 months.
* Thrombotic disorder.
* Use of systemic or topical medicines or substances which oppose the study objectives
* Regular use of therapeutic or recreational drugs, e.g., carnitine products, anabolics, high dose vitamins (except for indicated medications for renally impaired).
* Use of any herbal products or St. John's Wort within the last 14 days before intake of study intervention.
* Excluded therapies (e.g., physiotherapy, acupuncture, etc.) within 1 week before intake of study intervention.
* Change in chronic medications less than 2 weeks prior to dosing.
* Participation in another clinical study during the preceding 3 months for multiple dose studies and 1 month for single dose studies (last visit of participant to previous study to first treatment of new study).
* Exclusion periods from other studies or simultaneous participation in other clinical studies.
* Previous treatment during this study (allowing previously treated participants to be re-included into the study may lead to bias).
* Clinically relevant findings in the physical examination.
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV) (and with a positive polymerase chain reaction \[PCR\] result or increased liver transaminases or other signs of liver disease), HIV antibodies 1+2/HIV p24 antigen (HIV-1/2 combi test).
* Positive urine/mouth swab drug screening indicating drug abuse.
* Positive alcohol breath test.
* Special diets preventing the participants from eating the standard meals during the study.
* Physical exercise within 96 h before admission the study site.
* Regular daily consumption of more than 1 L of methylxanthine-containing food or beverages.
* Consumption of methylxanthine-containing beverages or food (e.g., coffee, tea, cola drinks, and chocolate) within 48 h before intake of study intervention.
* Smoking more than 10 cigarettes per day.
* Regular daily consumption of more than 500 mL (male participants) or 250 mL (female participants) of usual beer or the equivalent quantity of approximately 20 g (male participants) or 10 g (female participants) of alcohol in another form.
* Intake of foods or beverages containing alcohol within 96 h before intake of study intervention.
* Donation of more than 100 mL of whole blood or plasma within 4 weeks or 500 mL whole blood within 3 months before intake of study intervention.
* Plasmapheresis within 3 months prior to study intervention.
* Suspicion of drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT05515432
Study Brief:
Protocol Section:
NCT05515432