Clinical Trial, Phase IPhase 1NCT03402438
Renal Impairment Study
A Phase 1 study testing Fulacimstat (BAY1142524) in people with Clinical Trial, Phase I, run by Bayer at 1 site in Germany.
Trial summary
The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial, Phase I
- What is being tested?
- Fulacimstat (BAY1142524)
- 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
- 12 Feb 2018to 19 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
- Body mass index (BMI): 18 to 34 kg/m² (both inclusive)
- Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
- Subjects with renal impairment:
- eGFR <90 mL/min/1.73 m2 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.
- Needs to be within the required age and body weight range of Group 1 (which should not vary by more than+- 10 years and +-10 kg to Groups 2-4).
Who cannot join
- Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)
- Relevant impairment in liver function.
- Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Any organ transplant < 1 year before participation in this study.
- Subject under dialysis or planned to start dialysis during participation in the study.
- Failure of any other major organ system other than the kidney.
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, and Tolerability of a Single Oral 25 mg BAY 1142524 IR 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
The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
- Conditions
- Clinical Trial, Phase I
- Being tested
- Fulacimstat (BAY1142524)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulacimstat (BAY1142524)Drug
single oral dose of 25 mg immediate-release tablet BAY1142524
| Study group | Role | What they receive |
|---|---|---|
| Normal (healthy subjects) | Experimental | Healthy subjects matched for age, body weight and gender to the groups with renal impairment Receives: Drug: Fulacimstat (BAY1142524) |
| Mildly renal impaired | Experimental | Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2 Receives: Drug: Fulacimstat (BAY1142524) |
| Moderately renal impaired | Experimental | Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2 Receives: Drug: Fulacimstat (BAY1142524) |
| Severely renal impaired | Experimental | Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2 Receives: Drug: Fulacimstat (BAY1142524) |
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 (first) dose (AUC) of BAY1142524
AUC(0-tlast) will be used if mean AUC(tlast ∞) >20% of AUC)
Measured: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524
Measured: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC of unbound drug (AUCu) of BAY1142524
AUC (0-tlast) u will be used if mean AUC (tlast ∞) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.
Measured: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Cmax of unbound drug (Cmax,u) of BAY1142524
An additional blood sample for fu will be collected at 2 hours after dosing.
Measured: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
Secondary outcomes (1)
Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
Measured: up to 10 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start12 Feb 2018
- Primary completion4 Dec 2018
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Trial, Phase IStudies 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
- NCT03402438
- Sponsor's protocol ID
- 18106
- Other IDs
- 2017-003301-17, 2017
- Status last verified
- Mar 2020
- First submitted
- 11 Jan 2018
- Last updated
- 16 Mar 2020
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety, and Tolerability of a Single Oral 25 mg BAY 1142524 IR 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
- NCT03402438
- Acronym / sponsor ID
- 18106
- Conditions
- Clinical Trial, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 18 Jan 2018 (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 study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal (healthy subjects) | Experimental | Drug: Fulacimstat (BAY1142524)Healthy subjects matched for age, body weight and gender to the groups with renal impairment |
| Mildly renal impaired | Experimental | Drug: Fulacimstat (BAY1142524)Subjects with renal impairment and an estimated glomerular function rate between equal or above 60 and below 90 ml/min/1.75 m*2 |
| Moderately renal impaired | Experimental | Drug: Fulacimstat (BAY1142524)Subjects with renal impairment and an estimated glomerular function rate between equal or above 30 and below 60 ml/min/1.75 m*2 |
| Severely renal impaired | Experimental | Drug: Fulacimstat (BAY1142524)Subjects with renal impairment and an estimated glomerular function rate between below 30 ml/min/1.75 m*2 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index (BMI): 18 to 34 kg/m² (both inclusive)
- Men or confirmed postmenopausal women (by medical report verification and defined as exhibiting natural amenorrhea for at least 12 months before screening or as exhibiting natural amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels >40 mIU/mL, provided that no prior hormonal treatment has taken place) or women without childbearing potential based on surgical treatment at least 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy or hysterectomy (documented by medical report verification).
- Subjects with renal impairment:
- eGFR <90 mL/min/1.73 m2 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
Key exclusion criteria (6 listed)
- Clinically relevant findings(e.g. blood pressure, electrocardiogram, ECG; physical examination,laboratory examination)
- Relevant impairment in liver function.
- Pre-existing diseases (including impairment of liver function) for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Any organ transplant < 1 year before participation in this study.
- Subject under dialysis or planned to start dialysis during participation in the study.
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 |
|---|---|---|
| Fulacimstat (BAY1142524)single oral dose of 25 mg immediate-release tablet BAY1142524 | Drug | Mildly renal impaired, Moderately renal impaired, Normal (healthy subjects), Severely renal impaired |
Primary outcome
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1142524
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC(0-tlast) will be used if mean AUC(tlast ∞) >20% of AUC)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1142524
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC of unbound drug (AUCu) of BAY1142524
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
AUC (0-tlast) u will be used if mean AUC (tlast ∞) >20% of AUC). An additional blood sample for fu will be collected at 2 hours after dosing.
Cmax of unbound drug (Cmax,u) of BAY1142524
Time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose
An additional blood sample for fu will be collected at 2 hours after dosing.
1 secondary outcome
Number of subject with treatment emergent adverse events (TEAEs) as a measure of safety and tolerability
Time frame: up to 10 days 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 16 Mar 2020.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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 Fulacimstat (BAY1142524) in people with Clinical Trial, Phase I, 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 7 inclusion and 6 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 16 Mar 2020. 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 (first) dose (AUC) of BAY1142524 (time frame: Pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,6,8,10,12,15,24,36,48,96hours post dose). 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 16 Mar 2020; AzTrials last refreshed its copy on 1 Nov 2026.