AnemiaPhase 1NCT01458028
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
A Phase 1 study testing BAY85-3934 in people with Anemia, run by Bayer at 1 site in United States.
Trial summary
Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- BAY85-3934
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2011
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No diagnosis of any specific disease or condition
- Subjects are expected to be in good general health for their respective age range
- Male or female gender
- Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive)
- Racial group: Caucasian
Who cannot join
- 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. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease.
- Clinically relevant findings in the physical examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation
Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.
- Conditions
- Anemia
- Being tested
- BAY85-3934, Placebo
- Keywords
- BAY85-3934, pharmacokinetics, age, gender
- Medical subject headings
- Anemia, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY85-3934Drug
Single doses of 20 mg BAY85-3934 as tablet
PlaceboDrug
Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: BAY85-3934 |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934
Measured: Measured over 72 hours after dosing
Maximum drug concentration in plasma after single dose administration of BAY85-3934
Measured: Measured over 72 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline)
Measured: Measured over 96 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event)
Measured: Measured over 96 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline)
Measured: Measured over 72 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline)
Measured: Measured over 48 hours after dosing
Secondary outcomes (5)
Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours
Measured: 48 hours post dose
Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours
Measured: 96 hours post dose
Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours
Measured: 48 hours post dose
Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours
Measured: 96 hours post dose
Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours
Measured: 96 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT01458028
- Sponsor's protocol ID
- 14631
- Status last verified
- May 2014
- First submitted
- 20 Sep 2011
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Group, Double-Blind Study to Evaluate the Effects of Age and Gender on the Single-Dose Pharmacokinetics of BAY85-3934, Tablet Formulation
- ClinicalTrials.gov ID
- NCT01458028
- Acronym / sponsor ID
- 14631
- Conditions
- Anemia
- Keywords
- BAY85-3934, pharmacokinetics, age, gender
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Oct 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.
Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: BAY85-3934 |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No diagnosis of any specific disease or condition
- Subjects are expected to be in good general health for their respective age range
- Male or female gender
- Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive)
- Racial group: Caucasian
Key exclusion criteria (2 listed)
- 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. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease.
- Clinically relevant findings in the physical examination
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 doses of 20 mg BAY85-3934 as tablet | Drug | Arm 1 |
| PlaceboSingle dose of placebo tablet matching the 20 mg BAY85-3934 tablet | Drug | Arm 2 |
Primary outcome
Area under the plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934
Time frame: Measured over 72 hours after dosing
Maximum drug concentration in plasma after single dose administration of BAY85-3934
Time frame: Measured over 72 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by physical examination (changes from baseline)
Time frame: Measured over 96 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by adverse events monitoring (number of subjects with a specific event)
Time frame: Measured over 96 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by electrocardigram and and vital sign measurememnt (changes from baseline)
Time frame: Measured over 72 hours after dosing
Safety and tolerability of BAY 85-3934 after single dose administration as determined by laboratory testing (changes from baseline)
Time frame: Measured over 48 hours after dosing
5 secondary outcomes
Pharmacodynamic effects on erythropoietin as the change from baseline at 48 hours
Time frame: 48 hours post dose
Pharmacodynamic effects on reticulocytes as the change from baseline at 96 hours
Time frame: 96 hours post dose
Pharmacodynamic effects on hemoglobin as the change from baseline at 48 hours
Time frame: 48 hours post dose
Pharmacodynamic effects on hematocrit as the change from baseline at 96 hours
Time frame: 96 hours post dose
Pharmacodynamic effects on vascular endothelial growth factor (VEGF) as the change from baseline at 96 hours
Time frame: 96 hours post dose
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 6 May 2014.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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 United States.
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 5 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 6 May 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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 plasma concentration vs time curve from zero to infinity after single (first) dose of BAY85-3934 (time frame: Measured over 72 hours after dosing). The study lists 6 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 6 May 2014.