A Phase 1 interventional study of BAY1101042 and Placebo in Healthy Volunteer, sponsored by Bayer. Completed at 2 sites in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Bayer · Phase 1, Interventional, and Other
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Among 49 studies in Renal Insufficiency, Chronic by Bayer — 4 open to participants now, 8 under way, 2 of them phase 3. Renal Insufficiency, Chronic · Bayer.
Among the 49 studies in Renal Insufficiency, Chronic by Bayer, this one is the 17th largest by enrollment of the 32 interventional ones that give a count, is one of 3 that started in 2017, is one of 12 in phase 1, and was the 9th registered.
3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →4 of the 49 studies in Renal Insufficiency, Chronic by Bayer are open now, in 12 countries. Recruiting first, the newest first:
Bayer · Sites in Spain
Ages 18+
Bayer · Sites in United States, Germany, Japan and 1 more country
Ages 18+
Bayer · Sites in United States, Argentina, Australia and 29 more countries
Ages 1–18
Bayer · Sites in Mexico
Ages 18+
By country, each count listing its studies:
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years to 45 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
49 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 96 is above the median of 73 across 2,162 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 98 across the 32 interventional studies, 4,613 across the 17 observational. Of the 39 that completed or were terminated, 4 (10%) have results posted.
This tab as a report to print or save as PDF → With an account.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
4 of the studies in Renal Insufficiency, Chronic by Bayer that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT06763146BayerAn Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice | 2026-11-30 |
| NCT06278207BayerAn Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions | 2027-09-30 |
| NCT07232537BayerAn Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea | 2027-09-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 49 studies in Renal Insufficiency, Chronic by Bayer, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days
Drug: BAY1101042 · Drug: Placebo
Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)
Number of treatment emergent adverse events (TEAEs)
Assessment of treatment emergent adverse events from first study drug intake until follow up
Time frame: Approximately 19 days
AUC(0-24) of BAY1101042
AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose
Time frame: At day 1
AUC(0-24)/D of BAY1101042
AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose
Time frame: At day 1
Cmax of BAY1101042
Cmax: maximum observed drug concentration after single dose
Time frame: At day 1
Cmax/D of BAY1101042
Cmax/D: dose-normalized maximum observed drug concentration after single dose
Time frame: At day 1
AUCτ,md of BAY1101042
AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose
Time frame: At day 9
AUCτ,md/D of BAY1101042
AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose
Time frame: At day 9
Cmax,md of BAY1101042
Cmax,md: maximum observed drug concentration after multiple dose
Time frame: At day 9
Cmax,md/D of BAY1101042
Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose
Time frame: At day 9
Ran from Aug 2017 to primary completion in Apr 2019, 20 months.
Of 77 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 20 months is above that.
Counting every sponsor, half of 109 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BAY 1101042
Renal Insufficiency, Chronic →