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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06125366
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief 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.

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).

Condition or Disease	Intervention/Treatment	Phase
Contrast Enhancement in Magnetic Resonance Imaging; Healthy Volunteers	Drug: BAY1747846; Drug: Matching placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Masking Description: The study is performed according to a single-blind design, i.e. the participant is blinded to the allocation of treatment.
• Primary Purpose: Other
• 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
• Actual Study Start Date: Apr 17, 2019
• Actual Primary Completion Date: Jun 19, 2019
• Actual Study Completion Date: Jul 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation of BAY1747846	Drug: BAY1747846; Single dose; IV injection.
Placebo Comparator: Matching Placebo	Drug: Matching placebo; Single dose; IV injection.

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-emergent adverse events [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.)]

2. Severity of treatment-emergent adverse events [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

1. Maximum observed drug concentration in measured matrix after single dose administration (Cmax) [Pre-dose, on Day 1, Day 2, Day 3 and Day 4.]

2. Area under the concentration vs. time curve from zero to infinity after single dose (AUC) [Pre-dose, on Day 1, Day 2, Day 3 and Day 4.]

3. Total body clearance of drug (CL) [Pre-dose, on Day 1, Day 2, Day 3 and Day 4.]

4. Total body clearance of drug normalized by body weight (CL/bw) [Pre-dose, on Day 1, Day 2, Day 3 and Day 4.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SOUSEIKAI Fukuoka Mirai Hospital	Fukuoka		Japan	813-0017

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT06125366
• Other Study ID Numbers: 19414
• First Posted: Nov 9, 2023
• Last Update Posted: Nov 9, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 9, 2023