Heart FailurePhase 1NCT01687920
Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
A Phase 1 study testing BAY94-8862 (1.25mg), BAY94-8862 (2.5mg) and BAY94-8862 (5mg) in people with Heart Failure, run by Bayer at 1 site in Germany.
Trial summary
This study should estimate the dose proportionality of BAY94-8862 IR tablets. Read more about this study
- Who is it for?
- Ages 18 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- BAY94-8862 (1.25mg), BAY94-8862 (2.5mg) and BAY94-8862 (5mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 17 Sep 2012to 21 Mar 2013
- 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 46 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject
- Age: 18 to 46 years (inclusive) at the first screening examination
- Ethnicity: White
- Body mass index (BMI): >= 18 and <= 29.9 kg / m²
Who cannot join
- Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 50 or above 95 beats/ min
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
- Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
Trial locations and contacts
1 site in 1 country.
Germany1 site
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, 41061
About this study
Official title: Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
- Conditions
- Heart Failure
- Being tested
- BAY94-8862 (1.25mg), BAY94-8862 (2.5mg), BAY94-8862 (5mg), BAY94-8862 (7.5mg), BAY94-8862 (10mg)
- Keywords
- Cardiac disorders
- Medical subject headings
- Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY94-8862 (1.25mg)Drug
BAY94-8862 (2.5mg)Drug
BAY94-8862 (5mg)Drug
BAY94-8862 (7.5mg)Drug
BAY94-8862 (10mg)Drug
| Study group | Role | What they receive |
|---|---|---|
| BAY94-8862 (1.25mg) | Experimental | single dose BAY94-8862 IR tablet 1.25mg Receives: Drug: BAY94-8862 (1.25mg) |
| BAY94-8862 (2.5mg) | Experimental | single dose BAY94-8862 IR tablet 2.5mg Receives: Drug: BAY94-8862 (2.5mg) |
| BAY94-8862 (5mg) | Experimental | single dose BAY94-8862 IR tablet 5mg Receives: Drug: BAY94-8862 (5mg) |
| BAY94-8862 (7.5mg) | Experimental | single dose BAY94-8862 IR tablet 7.5mg Receives: Drug: BAY94-8862 (7.5mg) |
| BAY94-8862 (10mg) | Experimental | single dose BAY94-8862 IR tablet 10mg Receives: Drug: BAY94-8862 (10mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
Measured: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Measured: Up to 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study start17 Sep 2012
- Primary completion28 Nov 2012
- Study completion21 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01687920
- Sponsor's protocol ID
- 15481
- Other IDs
- 2012-003055-10
- Status last verified
- Jan 2022
- First submitted
- 14 Sep 2012
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)
- ClinicalTrials.gov ID
- NCT01687920
- Acronym / sponsor ID
- 15481
- Conditions
- Heart Failure
- Keywords
- Cardiac disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2012 (actual)
- Primary completion
- 28 Nov 2012 (actual)
- Study completion
- 21 Mar 2013 (actual)
- First posted
- 19 Sep 2012 (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.
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BAY94-8862 (1.25mg) | Experimental | Drug: BAY94-8862 (1.25mg)single dose BAY94-8862 IR tablet 1.25mg |
| BAY94-8862 (2.5mg) | Experimental | Drug: BAY94-8862 (2.5mg)single dose BAY94-8862 IR tablet 2.5mg |
| BAY94-8862 (5mg) | Experimental | Drug: BAY94-8862 (5mg)single dose BAY94-8862 IR tablet 5mg |
| BAY94-8862 (7.5mg) | Experimental | Drug: BAY94-8862 (7.5mg)single dose BAY94-8862 IR tablet 7.5mg |
| BAY94-8862 (10mg) | Experimental | Drug: BAY94-8862 (10mg)single dose BAY94-8862 IR tablet 10mg |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subject
- Age: 18 to 46 years (inclusive) at the first screening examination
- Ethnicity: White
- Body mass index (BMI): >= 18 and <= 29.9 kg / m²
Key exclusion criteria (6 listed)
- Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 50 or above 95 beats/ min
- Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
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 |
|---|---|---|
| BAY94-8862 (1.25mg) | Drug | BAY94-8862 (1.25mg) |
| BAY94-8862 (2.5mg) | Drug | BAY94-8862 (2.5mg) |
| BAY94-8862 (5mg) | Drug | BAY94-8862 (5mg) |
| BAY94-8862 (7.5mg) | Drug | BAY94-8862 (7.5mg) |
| BAY94-8862 (10mg) | Drug | BAY94-8862 (10mg) |
Primary outcome
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Time frame: Up to 48 h
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 7 Feb 2022.
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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 BAY94-8862 (1.25mg), BAY94-8862 (2.5mg) and BAY94-8862 (5mg) in people with Heart Failure, 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 4 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 7 Feb 2022. 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?
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets (time frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h). 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 7 Feb 2022.