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A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function

Primary Purpose

Contrast Enhancement in Magnetic Resonance Imaging

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BAY1747846

About this trial

This is an interventional basic science trial for Contrast Enhancement in Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent
Renally Impaired Participants and Disease Characteristics
- Mildly or moderately decreased renal function, as assessed by estimated glomerular filtration rate (eGFR). Mildly impaired renal function: eGFR: 60 up to 89 mL/min/1.73 m^2 (inclusive); Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m^2 (inclusive)
- Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening
Participants with normal renal function: Normal renal function, as assessed by eGFR ≥90 mL/min/1.73 m^2
Body mass index (BMI) within the range 18 - 40 kg/m^2 (inclusive)
Body weight (bw) ≥ 45 kg
Study participants of reproductive potential must agree to use adequate contraception when sexually active.
Male participants must agree not to donate sperm from the signing of the ICF until the follow-up visit on Day 12 (± 2d).

Exclusion Criteria:

Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment
Acute renal failure or acute nephritis within the past 2 years
Febrile illness within 1 week before study drug administration
Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
Conditions associated with a risk of hypersensitivity reactions as judged by the investigator
Any participant not able to produce urine and/or needing dialysis
Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention
Contrast agent administration within one month prior to screening or during the screening period
Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention
Clinically relevant abnormalities in physical examination, ECG, clinical chemistry, hematology, or urinalysis as judged by the investigator
Heart rate below 45 bpm or above 110 bpm
Systolic blood pressure below 90 mmHg or above 170 mmHg
Diastolic blood pressure below 45 or above 105 mmHg
Indication or evidence for long QT syndrome for all participants; additionally for participants with normal renal function: QT interval corrected using Fridericia's method (QTcF) > 470 msec
History of COVID-19 within 6 months prior to screening
Long COVID-19 syndrome or other clinically relevant COVID-19-related symptoms or sequela
Incomplete SARS-CoV-2 vaccination
Vaccination planned before completion of the last study visit

Sites / Locations

Clinical Pharmacology of Miami, LLC
Alliance for Multispecialty Research, LLC - Knoxville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Mild renal impairment

Moderate renal impairment

Normal renal function

Arm Description

Participants with mild renal impairment will receive a single dose of BAY1747846.

Participants with moderate renal impairment will receive a single dose of BAY1747846.

Participants with normal renal function will receive a single dose of BAY1747846.

Outcomes

Primary Outcome Measures

Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC)

Maximum observed drug concentration of BAY1747846 in plasma after single dose administration (Cmax)

Total body clearance of BAY1747846 normalized by body weight

Secondary Outcome Measures

Number of participants with treatment-emergent adverse events

Number of participants with treatment-emergent adverse events categorized by severity

Full Information

NCT ID

NCT05061979

First Posted

September 21, 2021

Last Updated

November 18, 2022

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT05061979

Brief Title

A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function

Official Title

Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of BAY1747846 in Participants With Impaired Renal Function in Comparison to Matched Participants With Normal Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 12, 2021 (Actual)

Primary Completion Date

March 16, 2022 (Actual)

Study Completion Date

July 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Researchers in this study want to learn how a new contrast agent for magnetic resonance imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics) after injection in participants with normal and impaired renal function. Impaired renal function is a condition where the kidneys do not work as well as they should. BAY1747846 belongs to the class gadolinium-based contrast agents (GBCAs). The way the body removes GBCAs including BAY1747846 from the blood is through the kidneys. So, when the kidneys are not working normally, it takes longer to remove BAY1747846 out of the body. The participants in this study will either have normal renal function, or will have mild or moderate impaired renal function. The participants will receive BAY1747846 one time through a needle into a vein. During the study, the participants will visit the study site about 6 times. The participants will stay at the study site for up to 9 days. Each participant will be in the study for up to 7 months. During the study, the doctors will: check the participants' overall health take blood and urine samples ask the participants about what medications they are taking and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Contrast Enhancement in Magnetic Resonance Imaging

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mild renal impairment

Arm Type

Experimental

Arm Description

Participants with mild renal impairment will receive a single dose of BAY1747846.

Arm Title

Moderate renal impairment

Arm Type

Experimental

Arm Description

Participants with moderate renal impairment will receive a single dose of BAY1747846.

Arm Title

Normal renal function

Arm Type

Experimental

Arm Description

Participants with normal renal function will receive a single dose of BAY1747846.

Intervention Type

Drug

Intervention Name(s)

BAY1747846

Intervention Description

Solution for intravenous (IV) injection, single dose

Primary Outcome Measure Information:

Title

Area under the concentration versus time curve from zero to infinity of BAY1747846 after single dose administration (AUC)

Time Frame

Pre-dose until 7 days post-dose

Title

Maximum observed drug concentration of BAY1747846 in plasma after single dose administration (Cmax)

Time Frame

Pre-dose until 7 days post-dose

Title

Total body clearance of BAY1747846 normalized by body weight

Time Frame

Pre-dose until 7 days post-dose

Secondary Outcome Measure Information:

Title

Number of participants with treatment-emergent adverse events

Time Frame

After administration of study intervention up to Day 12 (± 2 days)

Title

Number of participants with treatment-emergent adverse events categorized by severity

Time Frame

After administration of study intervention up to Day 12 (± 2 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant must be 18 to 79 years of age inclusive, at the time of signing the informed consent Renally Impaired Participants and Disease Characteristics Mildly or moderately decreased renal function, as assessed by estimated glomerular filtration rate (eGFR). Mildly impaired renal function: eGFR: 60 up to 89 mL/min/1.73 m^2 (inclusive); Moderately impaired renal function: eGFR: 30 up to 59 mL/min/1.73 m^2 (inclusive) Stable renal disease, i.e. a serum creatinine value determined 3 or more months before screening (e.g. during routine diagnostics) should not differ by more than 25% from the serum creatinine value determined at screening Participants with normal renal function: Normal renal function, as assessed by eGFR ≥90 mL/min/1.73 m^2 Body mass index (BMI) within the range 18 - 40 kg/m^2 (inclusive) Body weight (bw) ≥ 45 kg Study participants of reproductive potential must agree to use adequate contraception when sexually active. Male participants must agree not to donate sperm from the signing of the ICF until the follow-up visit on Day 12 (± 2d). Exclusion Criteria: Any relevant disease (other than those related to renal impairment for the renal impaired participants) within 4 weeks prior to study drug administration including infections and acute gastro-intestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment Acute renal failure or acute nephritis within the past 2 years Febrile illness within 1 week before study drug administration Malignancy diagnosed or treated within the past 5 years (hepatocellular carcinoma within the past 2 years). This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin Conditions associated with a risk of hypersensitivity reactions as judged by the investigator Any participant not able to produce urine and/or needing dialysis Dialysis for acute renal failure within the previous 6 months prior to administration of study intervention Contrast agent administration within one month prior to screening or during the screening period Indication for immunosuppressants, receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy within 6 months prior to administration of study intervention Clinically relevant abnormalities in physical examination, ECG, clinical chemistry, hematology, or urinalysis as judged by the investigator Heart rate below 45 bpm or above 110 bpm Systolic blood pressure below 90 mmHg or above 170 mmHg Diastolic blood pressure below 45 or above 105 mmHg Indication or evidence for long QT syndrome for all participants; additionally for participants with normal renal function: QT interval corrected using Fridericia's method (QTcF) > 470 msec History of COVID-19 within 6 months prior to screening Long COVID-19 syndrome or other clinically relevant COVID-19-related symptoms or sequela Incomplete SARS-CoV-2 vaccination Vaccination planned before completion of the last study visit

Facility Information:

Facility Name

Clinical Pharmacology of Miami, LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Alliance for Multispecialty Research, LLC - Knoxville

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

PubMed Identifier

35703267

Citation

Lohrke J, Berger M, Frenzel T, Hilger CS, Jost G, Panknin O, Bauser M, Ebert W, Pietsch H. Preclinical Profile of Gadoquatrane: A Novel Tetrameric, Macrocyclic High Relaxivity Gadolinium-Based Contrast Agent. Invest Radiol. 2022 Oct 1;57(10):629-638. doi: 10.1097/RLI.0000000000000889. Epub 2022 Jun 13.

Results Reference

derived

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