A Phase 1 interventional study of BAY3283142 and Placebo in Chronic Kidney Disease, Non-proliferative Diabetic Retinopathy and Healthy Volunteers, sponsored by Bayer. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Bayer · Phase 1, Interventional, and Other
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD) or non-proliferative diabetes retinopathy (NPDR). CKD is a long-term condition in which the ability of the kidneys to work decreases over time. It is often caused by high blood glucose levels. NPDR is another condition in which high blood glucose levels cause damage to the blood vessels of the retina, which is a tissue at the back of the eyes.
The study drug BAY3283142 works by activating a protein called soluble guanylate cyclase, which helps widen the blood vessels and regulate blood flow inside the body. This may help increase the blood flow in the kidneys and improve their function. It could also help to restore blood flow to the retina.
This study will include healthy participants who will not benefit from taking BAY3283142. However, the study will provide information on how to test BAY3283142 in future studies in participants with CKD or NPDR.
The main purpose of this study is to check how safe single and multiple doses of BAY3283142 are in healthy Chinese participants.
For this, researchers will collect the number and percentage of participants who have medical problems, which are also known as 'adverse events', after taking BAY3283142 or a placebo. A placebo looks like the study treatment but does not have any medicine in it.
The study doctor will keep track of all adverse events that happen in the study, even if they are not related to the study treatments.
The participants will be randomly divided into 2 treatment groups. They will take either BAY3283142 as an immediate-release tablet, or a placebo tablet, once, by mouth, based on the group assigned to them. An immediate-release tablet quickly dissolves and releases the drug inside the body.
Participants will have a one-day break after taking the single dose and then continue taking their assigned treatment once daily for a week. Researchers will check two different dose strengths of BAY3283142 in this study, starting with a low dose first.
Each participant will be in the study for around 7 weeks, which includes:
A visit within 21 days before the first dose to confirm if the participant can take part in the study
A hospital stay of 15 days during which the participant will take the assigned study treatment and the study doctor will monitor the participant's health
A visit after 7 to 10 days of taking the last dose during which the study doctor will perform a health check-up of the participant
During the study, the study doctor and his/her team will:
Test participants' blood and urine samples and check their overall health
Monitor participants' heart health by electrocardiogram (ECG) and measure their blood pressure and heart rate
As this study is conducted in healthy participants who will not gain any benefit from the treatment, access to the treatment after the study is not planned.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 24 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive a low dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days.
Drug: BAY3283142
Participants will receive a high dose of BAY3283142 on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days.
Drug: BAY3283142
Participants will receive placebo on Day 1 followed by 1 day without dosing and a multiple dose phase for 7 days.
Drug: Placebo
IR tablets, oral
Placebo matched to BAY3283142
Number of participants with treatment emergent adverse event (TEAEs)
Time frame: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
Percentage of participants with treatment emergent adverse event (TEAEs)
Time frame: From first study intervention administration until [including] 7 days after end of treatment with study intervention (approximately 25 days)
AUC of BAY3283142
AUC: Area under the concentration vs. Time curve from zero to infinity after single (first) dose
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
Cmax of BAY3283142
Cmax: Maximum observed drug concentration in measured matrix after single dose administration, directly taken from analytical data
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
AUC/D of BAY3283142
AUC/D: AUC divided by dose
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
Cmax/D of BAY3283142
Cmax/D: Cmax devided by dose
Time frame: 0 to 48 hours post-dose after the first dose on Day 1
AUCτ,md of BAY3283142
AUCτ,md: AUC during any dose interval after multiple dose
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
Cmax,md of BAY3283142
Cmax,md: Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval, directly taken from analytical data
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
AUCτ,md/D of BAY3283142
AUCτ,md/D: AUC during any dose interval after multiple dose divided by dose
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
Cmax,md/D of BAY3283142
Cmax,md/D: Cmax,md divided by dose
Time frame: 0 to 24 hours post-dose after the last dose on Day 9
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
No publications or documents are linked to this record.
Ran from Jul 2024 to primary completion in Sep 2024, 2 months.
Of 76 industry-sponsored phase 1 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 2 months is below that.
Counting every sponsor, half of 109 studies reached it within 12 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Nurandociguat
Renal Insufficiency, Chronic →