Renal ImpairmentPhase 1NCT05631938
Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
A Phase 1 study testing cytisinicline in people with Renal Impairment, run by Achieve Life Sciences at 6 sites in 2 countries.
Trial summary
The primary objectives of this study are: 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- cytisinicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 10 Jan 2023to 4 Sep 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free written informed consent prior to any procedure required by the study.
- 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/m^2, inclusive, at Screening.
- A female subject is eligible if she meets one of the following criteria:
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- 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
- 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.
- Additional Inclusion Criteria for Subjects with Renal Impairment (Groups 2 to 5)
- eGFR at Screening, determined by the Cockcroft-Gault equation, 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)
- Subjects with ESRD are on dialysis for at least 3 months prior to Screening.
- Systolic blood pressure (SBP) 100-180mmHg, diastolic blood pressure (DBP) 50-105 mmHg, and pulse rate 50-100 bpm (inclusive), at Screening and Admission.
- Additional Inclusion Criteria for Subjects with Normal Renal Function (Group 1)
- Estimated glomerular filtration rate (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 60-90 mmHg, 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.
Who cannot join
- Known hypersensitivity/allergy reaction to cytisinicline substance or any of the excipients.
- History of renal, heart, and/or liver transplant.
- 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 Diagnostic and Statistical Manual of Mental Disorders 5 (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.
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- 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.
- Positive result in drugs-of-abuse or ethanol tests at Screening or Admission. NOTE: Subjects receiving stable treatment of methadone and benzodiazepines will be allowed to be enrolled in the study even if the urine drug screen test is positive.
- 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.
- Additional Exclusion Criteria for subjects with Renal Impairment (Group 2 to 5)
- 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.
- 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.
- Additional Exclusion Criteria for Subjects with ESRD (Group 5)
- Blood hemoglobin <10 g/dL at Screening.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Portugal3 sites
Hospital de Braga, Centro Clínico Académico Braga, Associação
Braga, Braga District, 4710-243
BlueClinical Phase I
Porto, Porto District, 4250-449
Early Phase Clinical Trials Unit | CHVNG/E + BlueClinical
Vila Nova de Gaia, Porto District, 4434-502
Spain3 sites
Hospital Universitario de La Princessa
Madrid, Madrid, 28006
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario La Paz
Madrid, Madrid, 28046
About this study
Official title: 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.
The primary objectives of this study are:
- 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.
- To investigate the extent of cytisinicline removal by hemodialysis.
- Conditions
- Renal Impairment
- Being tested
- cytisinicline
- Keywords
- Dialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytisiniclineDrug
Also called cytisine
film-coated oral tablets containing 3 mg cytisinicline
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Normal Renal Function | Experimental | Participants with normal renal function receive a 3 mg single dose of cytisinicline. Receives: Drug: cytisinicline |
| Group 2: Mild Renal Impairment | Experimental | Participants with mild renal impairment receive a 3 mg single dose of cytisinicline. Receives: Drug: cytisinicline |
| Group 3: Moderate Renal Impairment | Experimental | Participants with moderate renal impairment receive a 3 mg single dose of cytisinicline. Receives: Drug: cytisinicline |
| Group 4: Severe Renal Impairment | Experimental | Participants with severe renal impairment receive a 3 mg single dose of cytisinicline. Receives: Drug: cytisinicline |
| Group 5: ESRD Participants Undergoing Dialysis | Experimental | Participants with ESRD undergoing dialysis receive a 3 mg single dose of cytisinicline on 2 occasions: after and prior to a dialysis session. Receives: Drug: cytisinicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Time of Occurrence of Cmax (Tmax)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time of Dosing (t=0h) to the Time of the Last Measurable Concentration (AUC0-t)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Total AUC Extrapolated to Infinity (AUC0-∞)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Terminal Elimination Rate Constant (λz)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Terminal Elimination Half-Life (t1/2)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Fraction Unbound (fu)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Clearance (CL/F)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Volume of Distribution (V/F)
Measured: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Urine PK Parameter: Amount of Drug Excreted in Urine (Ae)
Measured: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Fraction of Unchanged Drug Excreted in Urine (fe)
Measured: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Area Under the Urine Excretion Rate Curve From Time Zero to Last Measurable Observed Excretion Rate (AURC)
Measured: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Renal Clearance (CLR)
Measured: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Apparent Nonrenal Clearance (CLNR/F)
Measured: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Amount of Drug Recovered From Each Dialysate Collection (AD)
Measured: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Cumulative Amount of Drug Recovered From the Dialysate (AD, total)
Measured: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Partial Area Under the Curve Estimated From Predialyzer Samples Collected From Start of Dialysis (t0) to End of Dialysis (t1) (AUCt0-t1)
Measured: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Dialysis Clearance (CLD)
Measured: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Fraction of the Administered Dose That is Recovered in the Dialysate (Frem)
Measured: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
Secondary outcomes (9)
Number of Participants With Clinically Significant Changes from Baseline in Body Weight
Measured: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Systolic and Diastolic Blood Pressure
Measured: Baseline (pre-dose), 2, 6, 24, 36 and 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Pulse Rate
Measured: Baseline (pre-dose), 2, 6, 24, 36 and 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Body Temperature
Measured: Baseline (pre-dose), 2, 6, 24, 36 and 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Hematology Values
Hematology assessments include hemoglobin, red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width, white cell count with differential (neutrophil, eosinophil, basophil, lymphocyte and monocyte), platelet count and mean platelet volume.
Measured: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Biochemistry Values
Biochemistry values include sodium, potassium, glucose, creatinine, estimated creatinine clearance, total, direct and indirect bilirubin, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), creatine phosphokinase (CPK), total protein and albumin.
Measured: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Coagulation Values
Coagulation assessments include prothrombin rate, prothrombin time-international normalized ratio (INR) and activated partial thromboplastin time (aPTT).
Measured: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Urinalysis Values
Urinalysis assessments include pH, specific gravity, protein, hemoglobin, glucose, ketones, bilirubin, nitrites, urobilinogen, and microscopy (if urine is available).
Measured: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Measured: Groups 1 to 4: approximately 25 days; Group 5: approximately 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start10 Jan 2023
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serafim Guimarães, MD, PhD, Principal investigator, Blueclinical, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631938
- Sponsor's protocol ID
- ACH-CYT-05
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05631938
- Acronym / sponsor ID
- ACH-CYT-05
- Conditions
- Renal Impairment
- Keywords
- Dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 30 Nov 2022 (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.
The primary objectives of this study are:
- 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.
- To investigate the extent of cytisinicline removal by hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: Normal Renal Function | Experimental | Drug: cytisiniclineParticipants with normal renal function receive a 3 mg single dose of cytisinicline. |
| Group 2: Mild Renal Impairment | Experimental | Drug: cytisiniclineParticipants with mild renal impairment receive a 3 mg single dose of cytisinicline. |
| Group 3: Moderate Renal Impairment | Experimental | Drug: cytisiniclineParticipants with moderate renal impairment receive a 3 mg single dose of cytisinicline. |
| Group 4: Severe Renal Impairment | Experimental | Drug: cytisiniclineParticipants with severe renal impairment receive a 3 mg single dose of cytisinicline. |
| Group 5: ESRD Participants Undergoing Dialysis | Experimental | Drug: cytisiniclineParticipants with ESRD undergoing dialysis receive a 3 mg single dose of cytisinicline on 2 occasions: after and prior to a dialysis session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Free written informed consent prior to any procedure required by the study.
- 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/m^2, inclusive, at Screening.
Key exclusion criteria (25 listed)
- Known hypersensitivity/allergy reaction to cytisinicline substance or any of the excipients.
- History of renal, heart, and/or liver transplant.
- 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 Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) classification, within the 3-year period prior to Screening.
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 |
|---|---|---|
| cytisiniclineAlso: cytisinefilm-coated oral tablets containing 3 mg cytisinicline | Drug | Group 1: Normal Renal Function, Group 2: Mild Renal Impairment, Group 3: Moderate Renal Impairment, Group 4: Severe Renal Impairment, Group 5: ESRD Participants Undergoing Dialysis |
Primary outcome
Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Time of Occurrence of Cmax (Tmax)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time of Dosing (t=0h) to the Time of the Last Measurable Concentration (AUC0-t)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Total AUC Extrapolated to Infinity (AUC0-∞)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Terminal Elimination Rate Constant (λz)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Terminal Elimination Half-Life (t1/2)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Fraction Unbound (fu)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Clearance (CL/F)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Plasma PK Parameter: Apparent Volume of Distribution (V/F)
Time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose
Urine PK Parameter: Amount of Drug Excreted in Urine (Ae)
Time frame: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Fraction of Unchanged Drug Excreted in Urine (fe)
Time frame: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Area Under the Urine Excretion Rate Curve From Time Zero to Last Measurable Observed Excretion Rate (AURC)
Time frame: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Renal Clearance (CLR)
Time frame: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
Urine PK Parameter: Apparent Nonrenal Clearance (CLNR/F)
Time frame: pre-dose, 00:00-04:00 (groups 1-4), 00:00-06:00 (group 5), 04:00-08:00 (groups 1-4), 06:00-08:00 (group 5), 08:00-12:00, 12:00-24:00, 24:00-36:00 and 36:00-48:00 hours:minutes post-dose
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Amount of Drug Recovered From Each Dialysate Collection (AD)
Time frame: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Cumulative Amount of Drug Recovered From the Dialysate (AD, total)
Time frame: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Partial Area Under the Curve Estimated From Predialyzer Samples Collected From Start of Dialysis (t0) to End of Dialysis (t1) (AUCt0-t1)
Time frame: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Dialysis Clearance (CLD)
Time frame: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Fraction of the Administered Dose That is Recovered in the Dialysate (Frem)
Time frame: Day 1 pre-dialysis, post-dialysis (before the hemodialysis is stopped), and for 1 minute every hour during hemodialysis
9 secondary outcomes
Number of Participants With Clinically Significant Changes from Baseline in Body Weight
Time frame: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Systolic and Diastolic Blood Pressure
Time frame: Baseline (pre-dose), 2, 6, 24, 36 and 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Pulse Rate
Time frame: Baseline (pre-dose), 2, 6, 24, 36 and 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Body Temperature
Time frame: Baseline (pre-dose), 2, 6, 24, 36 and 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Hematology Values
Time frame: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Biochemistry Values
Time frame: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Coagulation Values
Time frame: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Clinically Significant Changes from Baseline in Urinalysis Values
Time frame: Baseline (pre-dose), 48 hours post-dose
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Groups 1 to 4: approximately 25 days; Group 5: approximately 31 days
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 11 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Serafim Guimarães, MD, PhD principal investigator
Blueclinical, Ltd.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cytisinicline in people with Renal Impairment, run by Achieve Life Sciences at 6 sites in 2 countries.
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 25 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Portugal, Spain. 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?
Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) (time frame: pre-dose; 00:20, 00:40, 01:00, 01:20, 01:40, 02:00, 02:30, 03:00, 04:30, 06:00, 08:00, 12:00; 24:00, 36:00 and 48:00 hours:minutes post-dose). The study lists 19 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 11 Jul 2025.