Renal ImpairmentPhase 1NCT03235076
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 Tablet Dose in Men and Woman With Renal Impairment and in Healthy Subjects
A Phase 1 study testing BAY1101042 in people with Renal Impairment, run by Bayer at 1 site in Germany.
Trial summary
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and… Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- BAY1101042
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2017to 13 Mar 2019
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and follow study-related instructions and ability to participate in the study for the entire period.
- Age: 18 to 79 years (inclusive) at the screening visit.
- Body mass index (BMI): 18 to 34 kg/m² (both inclusive).
- Male or female subject.
- Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy).
- Subjects with renal impairment:
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- eGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.
- Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
- Healthy subjects:
- eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing.
Who cannot join
- Pregnant or lactating women.
- Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 MR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight- Matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
- Conditions
- Renal Impairment
- Being tested
- BAY1101042
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1101042Drug
Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)
| Study group | Role | What they receive |
|---|---|---|
| Subjects with mild renal impairment | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) Receives: Drug: BAY1101042 |
| Subjects with moderate renal impairment | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) Receives: Drug: BAY1101042 |
| Subjects with severe renal impairment | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) Receives: Drug: BAY1101042 |
| Matched healthy subject group | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) Receives: Drug: BAY1101042 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
Measured: Study Day 1 to Study Day 6
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
Maximum observed concentration of BAY1101042 in plasma after single dose administration
Measured: Study Day 1 to Study Day 6
AUCu of BAY1101042
Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
Measured: Study Day 1 to Study Day 6
Cmax,u of BAY1101042
Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
Measured: Study Day 1 to Study Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start15 Aug 2017
- Primary completion7 Nov 2018
- Study completion13 Mar 2019
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.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235076
- Sponsor's protocol ID
- 18745
- Other IDs
- 2017-001141-28, 2017
- Status last verified
- Jun 2023
- First submitted
- 28 Jul 2017
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single Oral 10 mg BAY1101042 MR Tablet Dose in Male and Female Subjects With Renal Impairment and in Age-, Gender-, and Weight- Matched Healthy Subjects in a Single Center, Non-controlled, Open-label, Observational Design
- ClinicalTrials.gov ID
- NCT03235076
- Acronym / sponsor ID
- 18745
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 1 Aug 2017 (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.
To investigate the pharmacokinetics of BAY1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (eGFR) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of BAY1101042 after a single oral dose of a 10 mg BAY1101042 given as 5 mg modified release (MR) tablet.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects with mild renal impairment | Experimental | Drug: BAY1101042Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Subjects with moderate renal impairment | Experimental | Drug: BAY1101042Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Subjects with severe renal impairment | Experimental | Drug: BAY1101042Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
| Matched healthy subject group | Experimental | Drug: BAY1101042Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to understand and follow study-related instructions and ability to participate in the study for the entire period.
- Age: 18 to 79 years (inclusive) at the screening visit.
- Body mass index (BMI): 18 to 34 kg/m² (both inclusive).
- Male or female subject.
- Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy).
Key exclusion criteria (2 listed)
- Pregnant or lactating women.
- Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.
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 |
|---|---|---|
| BAY1101042Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets) | Drug | Matched healthy subject group, Subjects with mild renal impairment, Subjects with moderate renal impairment, Subjects with severe renal impairment |
Primary outcome
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042
Time frame: Study Day 1 to Study Day 6
Area under the concentration vs. time curve from zero to infinity after single dose of BAY1101042
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1101042
Time frame: Study Day 1 to Study Day 6
Maximum observed concentration of BAY1101042 in plasma after single dose administration
AUCu of BAY1101042
Time frame: Study Day 1 to Study Day 6
Area under the unbound concentration vs. time curve from zero to infinity after single dose of BAY1101042
Cmax,u of BAY1101042
Time frame: Study Day 1 to Study Day 6
Maximum observed unbound concentration of BAY1101042 in plasma after single dose administration of BAY1101042
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 5 Jun 2023.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY1101042 in people with Renal Impairment, run by Bayer at 1 site in Germany.
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 10 inclusion and 2 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Area under the concentration vs. time curve from zero to infinity after single dose (AUC) of BAY1101042 (time frame: Study Day 1 to Study Day 6). The study lists 4 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 5 Jun 2023.