Healthy VolunteerPhase 1NCT03252002
Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamic Effects of a Single and Multiple Oral BAY1101042 Tablet Doses in Healthy Male Subjects
A Phase 1 study testing BAY1101042 in people with Healthy Volunteer, run by Bayer at 2 sites in Germany.
Trial summary
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BAY1101042
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Aug 2017to 24 Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The informed consent must be signed before any study specific tests or procedures are done.
- Healthy male subject.
- Age: 18 to 45 years (inclusive) at the screening.
- Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
- Ability to understand and follow study-related instructions.
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.
- Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
- Regular use of medicines.
- Smoking more than 10 cigarettes daily.
- Systolic blood pressure below 100 or above 145 mmHg (at screening).
- Diastolic blood pressure below 50 or above 90 mmHg (at screening).
- Heart rate below 50 or above 90 beats/ min (at screening).
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, 41061
CRS Clinical Research Services Wuppertal GmbH
Wuppertal, North Rhine-Westphalia, 42113
About this study
Official title: Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
- Conditions
- Healthy Volunteer
- Being tested
- BAY1101042, Placebo
- Keywords
- Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1101042Drug
Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
PlaceboDrug
Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)
| Study group | Role | What they receive |
|---|---|---|
| Single/multiple doses of 10 mg BAY1101042 or placebo | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days Receives: Drug: BAY1101042; Drug: Placebo |
| Single/ multiple doses of 20 mg BAY1101042 or placebo | Experimental | Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days Receives: Drug: BAY1101042; Drug: Placebo |
| Single/ multiple doses of 30 mg BAY1101042 or placebo | Experimental | Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days Receives: Drug: BAY1101042; Drug: Placebo |
| Single/ multiple doses of 40 mg BAY1101042 or placebo | Experimental | Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days Receives: Drug: BAY1101042; Drug: Placebo |
| Single/ multiple doses of 50 mg BAY1101042 or placebo | Experimental | Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days Receives: Drug: BAY1101042; Drug: Placebo |
| Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo | Experimental | Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days Receives: Drug: BAY1101042; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Assessment of treatment emergent adverse events from first study drug intake until follow up
Measured: Approximately 19 days
Secondary outcomes (8)
AUC(0-24) of BAY1101042
AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose
Measured: At day 1
AUC(0-24)/D of BAY1101042
AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose
Measured: At day 1
Cmax of BAY1101042
Cmax: maximum observed drug concentration after single dose
Measured: At day 1
Cmax/D of BAY1101042
Cmax/D: dose-normalized maximum observed drug concentration after single dose
Measured: At day 1
AUCτ,md of BAY1101042
AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose
Measured: At day 9
AUCτ,md/D of BAY1101042
AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose
Measured: At day 9
Cmax,md of BAY1101042
Cmax,md: maximum observed drug concentration after multiple dose
Measured: At day 9
Cmax,md/D of BAY1101042
Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose
Measured: At day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start16 Aug 2017
- Primary completion30 Apr 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 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
- NCT03252002
- Sponsor's protocol ID
- 18747
- Other IDs
- 2017-001212-11, 2017
- Status last verified
- Aug 2019
- First submitted
- 4 Aug 2017
- Last updated
- 19 Aug 2019
- 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 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single/Multiple Dose Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BAY1101042 Given as 5 mg MR Tablet After Single Oral Dosing Followed by Once Daily Dosing for 7 Days in 12 Healthy Male Subjects Per Dose Step in a Randomized, Placebo Controlled, Single Blind, Group Comparison Design
- ClinicalTrials.gov ID
- NCT03252002
- Acronym / sponsor ID
- 18747
- Conditions
- Healthy Volunteer
- Keywords
- Chronic kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 16 Aug 2017 (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.
To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single/multiple doses of 10 mg BAY1101042 or placebo | Experimental | Drug: BAY1101042, Drug: PlaceboSingle oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 20 mg BAY1101042 or placebo | Experimental | Drug: BAY1101042, Drug: PlaceboSingle oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 30 mg BAY1101042 or placebo | Experimental | Drug: BAY1101042, Drug: PlaceboSingle oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 40 mg BAY1101042 or placebo | Experimental | Drug: BAY1101042, Drug: PlaceboSingle oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Single/ multiple doses of 50 mg BAY1101042 or placebo | Experimental | Drug: BAY1101042, Drug: PlaceboSingle oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo | Experimental | Drug: BAY1101042, Drug: PlaceboSingle oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The informed consent must be signed before any study specific tests or procedures are done.
- Healthy male subject.
- Age: 18 to 45 years (inclusive) at the screening.
- Body mass index (BMI): above/equal 18 and below/equal 29.9 kg/m2.
- Ability to understand and follow study-related instructions.
Key exclusion criteria (7 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.
- Subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) levels outside the normal reference range at screening.
- Regular use of medicines.
- Smoking more than 10 cigarettes daily.
- Systolic blood pressure below 100 or above 145 mmHg (at screening).
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 |
|---|---|---|
| BAY1101042Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days | Drug | Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo, Single/ multiple doses of 20 mg BAY1101042 or placebo, Single/ multiple doses of 30 mg BAY1101042 or placebo, Single/ multiple doses of 40 mg BAY1101042 or placebo, Single/ multiple doses of 50 mg BAY1101042 or placebo, Single/multiple doses of 10 mg BAY1101042 or placebo |
| PlaceboSingle dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d) | Drug | Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo, Single/ multiple doses of 20 mg BAY1101042 or placebo, Single/ multiple doses of 30 mg BAY1101042 or placebo, Single/ multiple doses of 40 mg BAY1101042 or placebo, Single/ multiple doses of 50 mg BAY1101042 or placebo, Single/multiple doses of 10 mg BAY1101042 or placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: Approximately 19 days
Assessment of treatment emergent adverse events from first study drug intake until follow up
8 secondary outcomes
AUC(0-24) of BAY1101042
Time frame: At day 1
AUC(0-24)/D of BAY1101042
Time frame: At day 1
Cmax of BAY1101042
Time frame: At day 1
Cmax/D of BAY1101042
Time frame: At day 1
AUCτ,md of BAY1101042
Time frame: At day 9
AUCτ,md/D of BAY1101042
Time frame: At day 9
Cmax,md of BAY1101042
Time frame: At day 9
Cmax,md/D of BAY1101042
Time frame: At day 9
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 19 Aug 2019.
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Healthy Participants
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 BAY1101042 in people with Healthy Volunteer, 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 5 inclusion and 7 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 19 Aug 2019. 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. 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 treatment emergent adverse events (TEAEs) (time frame: Approximately 19 days). 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 19 Aug 2019.