Contrast Enhancement in Magnetic Resonance ImagingPhase 1NCT06125366
A Study to Learn More About the Safety and the Level of BAY 1747846 in Body Given as Injection Into the Vein at Increasing Single Doses in Japanese Healthy Male Participants
A Phase 1 study testing BAY1747846 in people with Contrast Enhancement in Magnetic Resonance Imaging and Healthy Volunteers, run by Bayer at 1 site in Japan.
Trial summary
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Japanese healthy male participants: the safety of BAY1747846 when given at increasing single doses the level of BAY1747846 in the body over time when given at increasing single doses. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Contrast Enhancement in Magnetic Resonance Imaging, Healthy Volunteers
- What is being tested?
- BAY1747846
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteJapan
- Study dates
- 17 Apr 2019to 11 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent prior to any study specific tests or procedures
- Ability and willingness to understand and follow study-related instructions
- Subject is healthy as determined by the investigator
- Japanese male
- Age 20 to 40 years (inclusive) at screening visit
- Body mass index (BMI): 18.0 to 28.0 kg/m^2(inclusive)
- Body weight: at least 50 kg (inclusive)
- Subjects of reproductive potential must agree to use condoms whenever having sexual intercourse with a woman of child-bearing potential. This applies to the time period from signing of the ICF to at least 1 week after treatment.
Who cannot join
- Current smoker, or has smoked within 3 months prior to screening Clinical Study Protocol
- Any severe disease within the last 4 weeks prior to administration of study drug
- History of orthostatic hypotension, fainting spells and blackouts
- Any malignant tumor and history thereof
- Any clinically relevant finding at the physical examination
- Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any contrast agent
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- Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the Upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL
- Clinically relevant ECG findings, e.g.: Heart rate <45 or > 90 beats/min, PR >220 msec, QTcF >450 msec, QRS >120 msec, branch bundle block, any sign of coronary heart disease at screening
- -. Abnormal vital signs, e.g.: Systolic blood pressure <90 or >140 mmHg, Diastolic blood pressure <45 or >90 mmHg at screening
- Subjects who have participated in a clinical study of an investigational drug within 4 months or an approved drug within 3 months prior to administration of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Japanese Healthy Male Subjects
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Japanese healthy male participants:
- the safety of BAY1747846 when given at increasing single doses
- the level of BAY1747846 in the body over time when given at increasing single doses.
Read more
To answer the first question, the researchers compared the number and severity of medical problems the Japanese participants had after receiving BAY 1747846 at increasing doses and placebo respectively. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
To answer the second question, the researchers determined:
- the (average) total level of BAY1747846 in the body, also called AUC
- the (average) highest level of BAY1747846 in the body, also called Cmax
- how BAY1747846 is removed from the body, also called clearance (CL).
- Being tested
- BAY1747846, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY1747846Drug
Single dose; IV injection.
Matching placeboDrug
Single dose; IV injection.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of BAY1747846 | Experimental | Not described Receives: Drug: BAY1747846 |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events
Measured: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)
Severity of treatment-emergent adverse events
Measured: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)
Secondary outcomes (4)
Maximum observed drug concentration in measured matrix after single dose administration (Cmax)
Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Area under the concentration vs. time curve from zero to infinity after single dose (AUC)
Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Total body clearance of drug (CL)
Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Total body clearance of drug normalized by body weight (CL/bw)
Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start17 Apr 2019
- Primary completion19 Jun 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Enhancement in Magnetic Resonance ImagingStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125366
- Sponsor's protocol ID
- 19414
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06125366
- Acronym / sponsor ID
- 19414
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 9 Nov 2023 (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.
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Japanese healthy male participants:
- the safety of BAY1747846 when given at increasing single doses
- the level of BAY1747846 in the body over time when given at increasing single doses.
To answer the first question, the researchers compared the number and severity of medical problems the Japanese participants had after receiving BAY 1747846 at increasing doses and placebo respectively. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
To answer the second question, the researchers determined:
- the (average) total level of BAY1747846 in the body, also called AUC
- the (average) highest level of BAY1747846 in the body, also called Cmax
- how BAY1747846 is removed from the body, also called clearance (CL).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of BAY1747846 | Experimental | Drug: BAY1747846 |
| Matching Placebo | Placebo comparator | Drug: Matching placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent prior to any study specific tests or procedures
- Ability and willingness to understand and follow study-related instructions
- Subject is healthy as determined by the investigator
- Japanese male
- Age 20 to 40 years (inclusive) at screening visit
Key exclusion criteria (10 listed)
- Current smoker, or has smoked within 3 months prior to screening Clinical Study Protocol
- Any severe disease within the last 4 weeks prior to administration of study drug
- History of orthostatic hypotension, fainting spells and blackouts
- Any malignant tumor and history thereof
- Any clinically relevant finding at 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 |
|---|---|---|
| BAY1747846Single dose; IV injection. | Drug | Dose escalation of BAY1747846 |
| Matching placeboSingle dose; IV injection. | Drug | Matching Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)
Severity of treatment-emergent adverse events
Time frame: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)
4 secondary outcomes
Maximum observed drug concentration in measured matrix after single dose administration (Cmax)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Area under the concentration vs. time curve from zero to infinity after single dose (AUC)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Total body clearance of drug (CL)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
Total body clearance of drug normalized by body weight (CL/bw)
Time frame: Pre-dose, on Day 1, Day 2, Day 3 and 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 9 Nov 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BAY1747846 in people with Contrast Enhancement in Magnetic Resonance Imaging and Healthy Volunteers, run by Bayer at 1 site in Japan.
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 8 inclusion and 10 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 9 Nov 2023. 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 Japan. 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 participants with treatment-emergent adverse events (time frame: Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.)). 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 9 Nov 2023.