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AzTrials

Contrast Enhancement in Magnetic Resonance ImagingPhase 1NCT06135181

A Study to Learn More About the Safety and the Blood Level of BAY1747846 Given as Injection Into the Vein at Increasing Single Doses in Chinese Healthy Male Participants

A Phase 1 study testing Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg and Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg in people with Contrast Enhancement in Magnetic Resonance Imaging and Healthy Volunteers, run by Bayer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Chinese healthy male participants: the safety of BAY1747846 when given at increasing single doses the level of BAY1747846 in the blood over time when given at increasing single doses. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg and Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteChina
Study dates
26 Aug 2020to 30 Apr 2021
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

  • Signed informed consent prior to any study specific tests or procedures
  • Chinese male between 18 and 45 years (inclusive) at screening visit
  • Body mass index (BMI): 18.5 to 30.0 kg/m² (inclusive)
  • Body weight (bw): 50 to 90 kg (inclusive)
  • Participants of reproductive potential must agree to use adequate contraception whenever having sexual intercourse with a woman of child-bearing potential. This applies for the time period from signing of the ICF to at least 1 week after treatment. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements
  • Healthy, based on medical history, physical examination, electrocardiography (ECG), and laboratory tests

Who cannot join

  • Use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (only use of contraceptives and occasional use of paracetamol, aspirin or ibuprofen is permissible)
  • Any severe disease within the last 4 weeks prior to the first study drug administration
  • Any clinically relevant finding at the physical examination and chest X ray (posterior-anterior) examination
  • 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
  • Vital signs: Pulse rate <50 or >90beats/min, Systolic blood pressure <100 or ≥140 mmHg, Diastolic blood pressure <60 or ≥90 mmHg, or other abnormal vital signs
  • Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any agent (including, but not limited to, any allergen, food, drug, chemical, or contrast agent)
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  • Family history of hypersensitivity reaction to contrast agent
  • Regular alcohol consumption equivalent to >20 g alcohol per day within 3 months prior to screening
  • Smokers who smoke more than 5 cigarettes per day within 3 months prior to screening and/or who cannot refrain from smoking from screening until the end of hospitalization
  • Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Hospital

    Beijing, 100730

Other trials in China

About this study

Official title: Randomized, Single-blind, Placebo-controlled, Escalating Single-dose Study of Safety, Tolerability, and Pharmacokinetics of Intravenously Administered BAY 1747846 in Healthy Chinese Men

The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Chinese healthy male participants:

  • the safety of BAY1747846 when given at increasing single doses
  • the level of BAY1747846 in the blood 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 Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively. Doctors kept tracking of all medical problems that happened in the study, even if they did 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 blood, also called AUC
  • the (average) highest level of BAY1747846 in the blood, also called Cmax
  • how BAY1747846 is removed from the blood, also called clearance (CL).
Being tested
Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg, Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg, Matching placebo
Keywords
Safety, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gadoquatrane (BAY1747846) 0.03 mmol Gd/kgDrug

    0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)

  • Gadoquatrane (BAY1747846) 0.1 mmol Gd/kgDrug

    0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)

  • Matching placeboDrug

    0.9% sodium chloride by intravenous injection (at 2 mL/s)

Study groups in NCT06135181
Study groupRoleWhat they receive
0.03 mmol Gd/kg BAY1747846 and matching placeboExperimental12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
Receives: Drug: Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg; Drug: Matching placebo
0.1 mmol Gd/kg BAY1747846 and matching placeboExperimental12 healthy male participants were planned to be enrolled into this arm, 9 on BAY1747846 and 3 on placebo
Receives: Drug: Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg; Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-emergent adverse events (TEAE)

    Including severity of TEAE

    Measured: From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)

Secondary outcomes (4)

  1. Cmax

    Cmax: Maximum observed drug concentration in measured matrix after single dose administration

    Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4

  2. AUC

    AUC: Area under the concentration vs. time curve from zero to infinity after single dose in case AUC cannot be determined reliably for all participants, AUC will be replaced by AUC(0-tlast)

    Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4

  3. CL

    CL: Total body clearance of drug

    Measured: Pre-dose, on Day 1, Day 2, Day 3 and Day 4

  4. CL/bw

    CL/bw: Total body clearance of drug normalized by body weight

    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.

  1. First posted18 Nov 2023
  2. Study start26 Aug 2020
  3. Primary completion2 Feb 2021
  4. Study completion30 Apr 2021

Resources

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
Model description
Parallel-group, consecutive cohort, escalating single-dose study design
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06135181
Sponsor's protocol ID
19730
Status last verified
Nov 2023
First submitted
13 Nov 2023
Last updated
18 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg and Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg in people with Contrast Enhancement in Magnetic Resonance Imaging and Healthy Volunteers, run by Bayer at 1 site in China.

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 6 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 18 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 China. 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 participants with treatment-emergent adverse events (TEAE) (time frame: From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06135181.

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 18 Nov 2023.

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