AnemiaPhase 1NCT01318551
Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects
A Phase 1 study testing BAY85-3934 in people with Anemia, run by Bayer at 1 site in Germany.
Trial summary
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and 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
- Anemia
- What is being tested?
- BAY85-3934
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2011to 14 Aug 2014
- 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
- The informed consent must be signed before any study-specific tests or procedures are done.
- Female subjects with no child-bearing potential (postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH concentrations >30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).
- Male subjects who agree to use 2 forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.
- Male subjects who agree not to act as sperm donors for 12 weeks after dosing.
- Age: ≥18 and ≤79 years at the pre-study visit.
- Body mass index (BMI): ≥18 and ≤34 kg/m2.
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- Ethnicity: white.
- • Subjects participating in this trial and having received 20 mg BAY 85 3934 are encouraged to participate in the following optionally 40 mg and 80 mg study parts.
- Ability to understand and follow study-related instructions.
- For subjects with renal impairment:
- In diseased subjects: CLCR <90 mL/min determined from a serum creatinine control.
- In diseased subjects: stable renal disease, ie a serum creatinine value determined at least 3 months before the pre-study visit during routine diagnostics independently of the study should not vary by more than 20% from the serum creatinine value determined at the pre-study visit.
- For healthy subjects:
- Mean age and body weight in Group 1 or Group 6 or Group 11 (control group, healthy subjects) and Groups 2 to 5 and Groups 7 to 10 and Groups 12 to 15 should not vary by more than +10 years and +10 kg, respectively..
- In diseased subjects: CLCR ≥90 mL/min determined from a serum creatinine control.
Who cannot join
- Participation in another clinical trial during the preceding 3 months for multiple-dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study).
- Exclusion periods from other studies or simultaneous participation in other clinical studies.
- Donation of >100 mL of blood within 4 weeks before the first study drug administration or >500 mL in the preceding 3 months.
- Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
- Severe infection or any clinically significant illness within 4 weeks prior to dosing.
- Known hypersensitivity to the study drugs (active substances, or excipients of the preparations).
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- Known severe allergies, non-allergic drug reactions, or multiple drug allergies.
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus antibodies (HIV 1/2 Ab).
- Regular use of recreational drugs, eg carnitine products, anabolics.
- Regular daily consumption of ≥ 0.5 L of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form.
- Suspicion of drug or alcohol abuse.
- Positive urine drug screening.
- Regular daily consumption of >25 cigarettes.
- Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety.
- Use of medication within the 2 weeks preceding the study which could interfere with the investigational product.
- For subjects with renal impairment:
- Acute renal failure.
- Acute nephritis.
- Nephrotic syndrome.
- Any organ transplant < 1 year before participation in this study.
- Failure of any other major organ system other than the kidney.
- Relevant impairment in liver function of by option of the investigator.
- Pre-existing diseases for which it can be assumed that the absorption of the study drugs will not be normal (ie relevant malabsorption, chronic diarrhea).
- Diastolic blood pressure (DBP) >100 mmHg and/or systolic blood pressure (SBP) >180 mmHg (at the pre-study examination; readings taken at the end of the dosing interval of antihypertensive medication, if any).
- Heart rate <45 or >100 BPM for subject aged 18 to ≤50 years and <55 or >110 BPM for subject aged >50 to ≤79 years at screening visit.
- Significant uncorrected rhythm or conduction disturbances such as a second- or third-degree AV block without a cardiac pacemaker or episodes of sustained ventricular tachycardia, or by option of the investigator.
- Diagnosed malignancy within the past 5 years.
- Psychiatric disorders which may disable the subjects to consent.
- Change in chronic medications <4 weeks prior to dosing.
- Concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications.
- For healthy subjects
- Subjects with conspicuous findings in medical history or pre-study examination by option of the investigator.
- A history of relevant diseases of vital organs, of the central nervous system or other organs.
- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Systolic blood pressure <100 mmHg or >145 mmHg.
- Diastolic blood pressure >95 mmHg.
- Heart rate <45 or >95 BPM for subject aged 18 to ≤50 years and <55 or >95 BPM for subject aged >50 to ≤79 years at screening visit.
- Clinically relevant findings in the ECG such as a second- or third-degree AV block, clinically relevant prolongation of the QRS complex >120 ms or of the QTc interval >450 ms for men and >470 ms for women of by option of the investigator.
- Clinically relevant deviations of the screened laboratory parameters in clinical chemistry, hematology, or urinalysis from reference range of by option of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacokinetics, Safety, Tolerability, and Pharmacodynamic Effects of BAY85-3934 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 20 mg and 40 mg (Optional) BAY 85-3934 Administered as Tablets in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
- Conditions
- Anemia
- Being tested
- BAY85-3934
- Keywords
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY85-3934Drug
single dose, 20 mg
BAY85-3934Drug
single dose, 40 mg (optional)
BAY85-3934Drug
single dose, 80 mg (optional)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY85-3934 |
| Arm 2 | Experimental | Not described Receives: Drug: BAY85-3934 |
| Arm 3 | Experimental | Not described Receives: Drug: BAY85-3934 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 4 weeks
Secondary outcomes (4)
Area under the plasma concentration versus time curve (AUC) of BAY85-3934
Measured: Day 0 to day 4
Peak Plasma Concentration (Cmax) of BAY85-3934
Measured: Day 0 to day 4
Dose-normalized area under the plasma concentration-time curve (AUCnorm) of BAY85-3934
Measured: Day 0 to day 4
Dose- and body weight-normalised Cmax (Cmax-norm) of BAY85-3934
Measured: Day 0 to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study start16 Mar 2011
- Primary completion5 Sep 2013
- Study completion14 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 56 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
- NCT01318551
- Sponsor's protocol ID
- 15557
- Other IDs
- 2011-000055-16
- Status last verified
- Jan 2021
- First submitted
- 10 Mar 2011
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacokinetics, Safety, Tolerability, and Pharmacodynamic Effects of BAY85-3934 in Male and Female Subjects With Renal Impairment and in Age- and Weight-matched Healthy Subjects Following a Single Oral Dose of 20 mg and 40 mg (Optional) BAY 85-3934 Administered as Tablets in a Single-center, Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
- ClinicalTrials.gov ID
- NCT01318551
- Acronym / sponsor ID
- 15557
- Conditions
- Anemia
- Keywords
- Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2011 (actual)
- Primary completion
- 5 Sep 2013 (actual)
- Study completion
- 14 Aug 2014 (actual)
- First posted
- 18 Mar 2011 (estimated)
- 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.
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in a single dose group stratified study in renal impaired and healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY85-3934 |
| Arm 2 | Experimental | Drug: BAY85-3934 |
| Arm 3 | Experimental | Drug: BAY85-3934 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The informed consent must be signed before any study-specific tests or procedures are done.
- Female subjects with no child-bearing potential (postmenopausal women with 12 months of spontaneous amenorrhea or with 6 months of spontaneous amenorrhea and serum FSH concentrations >30 mIU/mL, women with 6 weeks post bilateral ovariectomy, woman with bilateral tubal ligation, and women with hysterectomy).
- Male subjects who agree to use 2 forms of effective contraception during the study and for 12 weeks after receiving the study drug. This must include a condom with spermicide gel for 21 days after drug administration.
- Male subjects who agree not to act as sperm donors for 12 weeks after dosing.
- Age: ≥18 and ≤79 years at the pre-study visit.
Key exclusion criteria (39 listed)
- Participation in another clinical trial during the preceding 3 months for multiple-dose studies and 1 month for single-dose studies; (final examination from previous study to first treatment of new study).
- Exclusion periods from other studies or simultaneous participation in other clinical studies.
- Donation of >100 mL of blood within 4 weeks before the first study drug administration or >500 mL in the preceding 3 months.
- Medical disorder that would impair the subject's ability to complete the study in the opinion of the investigator.
- Severe infection or any clinically significant illness within 4 weeks prior to dosing.
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 |
|---|---|---|
| BAY85-3934single dose, 20 mg | Drug | Arm 1 |
| BAY85-3934single dose, 40 mg (optional) | Drug | Arm 2 |
| BAY85-3934single dose, 80 mg (optional) | Drug | Arm 3 |
Primary outcome
Number of participants with adverse events
Time frame: Up to 4 weeks
4 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of BAY85-3934
Time frame: Day 0 to day 4
Peak Plasma Concentration (Cmax) of BAY85-3934
Time frame: Day 0 to day 4
Dose-normalized area under the plasma concentration-time curve (AUCnorm) of BAY85-3934
Time frame: Day 0 to day 4
Dose- and body weight-normalised Cmax (Cmax-norm) of BAY85-3934
Time frame: Day 0 to day 4
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 27 Jan 2021.
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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 BAY85-3934 in people with Anemia, 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 15 inclusion and 39 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 27 Jan 2021. 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?
Number of participants with adverse events (time frame: Up to 4 weeks). 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 27 Jan 2021.