PharmacokineticsPhase 1NCT04004195
Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status
A Phase 1 study testing BAY2327949 in people with Pharmacokinetics, run by Bayer at 2 sites in Germany.
Trial summary
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- BAY2327949
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- 10 Jul 2019to 4 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be ≥18 years of age
- The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment).
- Race: White
- BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m*2 at the first screening visit.
- Male or female.
- Participants with renal impairment must have an eGFR (estimated glomerular filtration rate) <90 mL/min/1.73 m*2 determined from serum creatinine 21-3 days prior to dosing using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation (eGFR has to be repeated if screening period >10 days before dosing).
- Stable renal function, e.g. a serum creatinine value determined at least 3 months before the pre-study visit should not vary by more than 25% from the serum creatinine value determined at the pre-study visit confirmed by nephrologist or general practitioner the patient is under care.
Who cannot join
- Clinically relevant findings in the physical examination affecting the objectives of the study.
- Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:
- Moderate and strong inhibitors of CYP3A;
- Moderate and strong CYP3A inducers;
- Moderate and strong inhibitors of P-gp transport;
- UDP-glucuronosyltransferase (UGT) inhibitors probenecid and valproic acid.
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- Regular daily consumption of more than 10 cigarettes.
- Acute renal failure.
- Active nephritis.
- Impairment of any other major organ system other than the kidney.
- Change in chronic medications for renal disease (or its consequences) less than 4 weeks prior to dosing.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical-Research-Services Kiel GmbH
Kiel, Schleswig-Holstein, 24105
APEX GmbH
München, Bavaria, 81241
About this study
Official title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
- Conditions
- Pharmacokinetics
- Being tested
- BAY2327949
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2327949Drug
A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | Not described Receives: Drug: BAY2327949 |
| Participants with mild renal impairment | Experimental | Not described Receives: Drug: BAY2327949 |
| Participants with moderate renal impairment | Experimental | Not described Receives: Drug: BAY2327949 |
| Participants with severe renal impairment | Experimental | Not described Receives: Drug: BAY2327949 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of BAY2327949
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
Measured: From pre-dose until follow-up (10-12 days after dosing).
AUC of BAY2327949
AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose.
AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
Measured: From pre-dose until follow-up (10-12 days after dosing).
Cmax,u of BAY2327949
Cmax,u: Cmax based on the unbound plasma concentrations of the study drug
Measured: From pre-dose until follow-up (10-12 days after dosing).
AUCu of BAY2327949
AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
Measured: From pre-dose until follow-up (10-12 days after dosing).
Secondary outcomes (3)
Frequency and nature of treatment-emergent adverse events
Measured: Approximate 14 days (from starting treatment to end of follow-up)
Urinary volume
Measured: From Day -1 until Day 4 (72h after dosing)
Fluid balance
Measured: From Day -1 until Day 4 (72h after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start10 Jul 2019
- Primary completion7 Feb 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004195
- Sponsor's protocol ID
- 19224
- Other IDs
- 2019-000630-19, 2019
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight
- ClinicalTrials.gov ID
- NCT04004195
- Acronym / sponsor ID
- 19224
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 1 Jul 2019 (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.
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Drug: BAY2327949 |
| Participants with mild renal impairment | Experimental | Drug: BAY2327949 |
| Participants with moderate renal impairment | Experimental | Drug: BAY2327949 |
| Participants with severe renal impairment | Experimental | Drug: BAY2327949 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be ≥18 years of age
- The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment).
- Race: White
- BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m*2 at the first screening visit.
- Male or female.
Key exclusion criteria (11 listed)
- Clinically relevant findings in the physical examination affecting the objectives of the study.
- Systemic use of the following co-medications from 2 weeks before administration until end of follow-up:
- Regular daily consumption of more than 10 cigarettes.
- Acute renal failure.
- Active nephritis.
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 |
|---|---|---|
| BAY2327949A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision) | Drug | Healthy participants, Participants with mild renal impairment, Participants with moderate renal impairment, Participants with severe renal impairment |
Primary outcome
Cmax of BAY2327949
Time frame: From pre-dose until follow-up (10-12 days after dosing).
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
AUC of BAY2327949
Time frame: From pre-dose until follow-up (10-12 days after dosing).
AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose. AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
Cmax,u of BAY2327949
Time frame: From pre-dose until follow-up (10-12 days after dosing).
Cmax,u: Cmax based on the unbound plasma concentrations of the study drug
AUCu of BAY2327949
Time frame: From pre-dose until follow-up (10-12 days after dosing).
AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) >20% of AUC
3 secondary outcomes
Frequency and nature of treatment-emergent adverse events
Time frame: Approximate 14 days (from starting treatment to end of follow-up)
Urinary volume
Time frame: From Day -1 until Day 4 (72h after dosing)
Fluid balance
Time frame: From Day -1 until Day 4 (72h after dosing)
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 Jun 2020.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2327949 in people with Pharmacokinetics, run by Bayer at 2 sites 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 7 inclusion and 11 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cmax of BAY2327949 (time frame: From pre-dose until follow-up (10-12 days after dosing).). 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 11 Jun 2020.