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A Phase I, Open-Label Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
EU CTIS ID: 2022-500921-34-00
What this study is testing
1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with normal renal function. 2. To investigate the extent of cytisinicline removal by hemodialysis
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Free written informed consent prior to any procedure required by the study.
- Subjects with ESRD are on dialysis for at least 3 months prior to Screening
- Systolic blood pressure (SBP) 100-180 mmHg, diastolic blood pressure (DBP) 50-105 mmHg, and pulse rate 50–100 bpm (inclusive), at Screening and Admission.
- eGFR ≥90 mL/min at Screening, determined by the Cockcroft-Gault equation.
- No clinically relevant abnormalities on clinical laboratory tests at Screening.
- Blood pressure and pulse rate at Screening within the following ranges: • SBP 90-140 mmHg, DBP 60-90mmHg, and pulse rate 60-100 bpm (inclusive) for subjects <65 years of age. • SBP 95-160mmHg, DBP 65-–95 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects ≥65 years of age.
You likely can't join if
- Known hypersensitivity/allergy reaction to cytisinicline substance or any of the excipients.
- Positive result in drugs-of-abuse or ethanol tests at Screening or Admission.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Participation in any clinical trial within the previous 2 months.
- Loss of 250 mL or more blood within 3 months prior to screening.
- If female, positive pregnancy test in serum at Screening or positive pregnancy test in urine at Admission.
See the full eligibility criteria
Who can join
- Free written informed consent prior to any procedure required by the study.
- Subjects with ESRD are on dialysis for at least 3 months prior to Screening
- Systolic blood pressure (SBP) 100-180 mmHg, diastolic blood pressure (DBP) 50-105 mmHg, and pulse rate 50–100 bpm (inclusive), at Screening and Admission.
- eGFR ≥90 mL/min at Screening, determined by the Cockcroft-Gault equation.
- No clinically relevant abnormalities on clinical laboratory tests at Screening.
- Blood pressure and pulse rate at Screening within the following ranges: • SBP 90-140 mmHg, DBP 60-90mmHg, and pulse rate 60-100 bpm (inclusive) for subjects <65 years of age. • SBP 95-160mmHg, DBP 65-–95 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects ≥65 years of age.
- Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
- Willingness to accept and comply with all study procedures and restrictions.
- Male or female subject between 18 and 75 years, inclusive, at Screening.
- Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive, at Screening.
- A female subject is eligible if she meets one of the following criteria: a. is of non-childbearing potential (underwent a permanent sterilization method [e.g., hysterectomy, bilateral salpingectomy and bilateral oophorectomy], is clinically diagnosed infertile, or is in a post-menopausal state); or b. is of childbearing potential and agrees to use an accepted contraceptive method from at least 28 days prior to dose administration (prior to first dose administration for Group 5) until at least 1 month after the end of study (EOS).
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
- Stable concomitant medications for at least 7 days prior to dose administration (first dose administration for Group 5) and up to the EOS.
- eGFR at Screening within: • 60-89 mL/min for Group 2 (mild renal impairment subjects). • 30-59 mL/min for Group 3 (moderate renal impairment subjects). • 15-29 mL/min for Group 4 (severe renal impairment subjects). • <15 mL/min for Group 5 (ESRD subjects) determined by the Cockcroft-Gault equation
What rules you out
- Known hypersensitivity/allergy reaction to cytisinicline substance or any of the excipients.
- Positive result in drugs-of-abuse or ethanol tests at Screening or Admission.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Participation in any clinical trial within the previous 2 months.
- Loss of 250 mL or more blood within 3 months prior to screening.
- If female, positive pregnancy test in serum at Screening or positive pregnancy test in urine at Admission.
- If female, she is breast-feeding.
- Presence of severe cardiac disease.
- History of severe renal artery stenosis.
- Presence of unstable diabetes mellitus.
- Acute, ongoing, recurrent, or chronic systemic disease other than renal function impairment that could interfere with the evaluation of the study results.
- History of renal, heart, and/or liver transplant.
- Presence of any organ disorder, except for renal function impairment, which might interfere with the PK of cytisinicline.
- Use of any medication which might interfere with the PK of cytisinicline.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis), except for those related to renal impairment, at Screening.
- Blood hemoglobin <10g/dL at Screening.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
- Symptoms of an acute clinically relevant infection in the 4-week period preceding Screening (e.g., bacterial, viral, or fungal infection).
- History or clinical evidence of alcohol use disorder or substance use disorder according to DSM-5 classification, within the 3-year period prior to Screening.
- Clinically relevant abnormalities on a 12-lead electrocardiogram (ECG), recorded after 5 min in the supine position at Screening.
- Currently using any creatine supplement.
- Nicotine consumption (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) from 48 hours prior to Admission.
- Excessive caffeine consumption, defined as ≥800 mg per day at Screening.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.