Clinical Trials, Phase I as TopicPhase 1NCT02212080
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
A Phase 1 study testing BAY1214784 in people with Clinical Trials, Phase I as Topic, run by Bayer at 2 sites in Germany.
Trial summary
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Trials, Phase I as Topic
- What is being tested?
- BAY1214784
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2014to Mar 2015
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects
- Age 45 to 65 years
- Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
- Postmenopausal state
Who cannot join
- Incompletely cured 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
- Known or suspected malignant or benign tumors
- Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders
- Regular use of medicines
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Study site
Erfurt, Thuringia, 99084
Study site
Mönchengladbach, North Rhine-Westphalia, 41061
About this study
Official title: One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.
- Conditions
- Clinical Trials, Phase I as Topic
- Being tested
- BAY1214784, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1214784Drug
Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form
PlaceboDrug
Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form
| Study group | Role | What they receive |
|---|---|---|
| BAY1214784 | Experimental | Dose 1 to 7 of BAY1214784 Receives: Drug: BAY1214784 |
| Placebo | Placebo comparator | Placebo Dose 1 to 7 of BAY1214784 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Up to 2 weeks after dosing
Severity of adverse events (mild, moderate, severe)
Measured: Up to 2 weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Trials, Phase I as TopicStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT02212080
- Sponsor's protocol ID
- 16924
- Other IDs
- 2014-000412-34, 2014
- Status last verified
- Mar 2015
- First submitted
- 7 Aug 2014
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02212080
- Acronym / sponsor ID
- 16924
- Conditions
- Clinical Trials, Phase I as Topic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Aug 2014 (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 is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY1214784 | Experimental | Drug: BAY1214784Dose 1 to 7 of BAY1214784 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Dose 1 to 7 of BAY1214784 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy female subjects
- Age 45 to 65 years
- Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
- Postmenopausal state
Key exclusion criteria (4 listed)
- Incompletely cured 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
- Known or suspected malignant or benign tumors
- Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders
- Regular use of medicines
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 |
|---|---|---|
| BAY1214784Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form | Drug | BAY1214784 |
| PlaceboDose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form | Drug | Placebo |
Primary outcome
Number of adverse events
Time frame: Up to 2 weeks after dosing
Severity of adverse events (mild, moderate, severe)
Time frame: Up to 2 weeks 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 Mar 2015.
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
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 BAY1214784 in people with Clinical Trials, Phase I as Topic, 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 4 inclusion and 4 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 Mar 2015. 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. 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?
Number of adverse events (time frame: Up to 2 weeks after dosing). The study lists 2 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 Mar 2015.