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

November 6, 2023 updated by: Bayer

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 813-0017
        • SOUSEIKAI Fukuoka Mirai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Matching Placebo
Drug: Matching placebo
Single dose; IV injection.
Experimental: Dose escalation of BAY1747846
Drug: BAY1747846
Single dose; IV injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.)
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.)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
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.
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.
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.
Pre-dose, on Day 1, Day 2, Day 3 and Day 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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