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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06135181
• Other study ID #: 19730
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg
0.03 mmol Gd/kg by intravenous injection (at 2 mL/s)
• Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg
0.1 mmol Gd/kg by intravenous injection (at 2 mL/s)
• Matching placebo
0.9% sodium chloride by intravenous injection (at 2 mL/s)

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent adverse events (TEAE)	Including severity of TEAE	From drug administration up to 7 days after end of test drug administration (from day 1 to day 8)
Secondary	Cmax	Cmax: Maximum observed drug concentration in measured matrix after single dose administration	Pre-dose, on Day 1, Day 2, Day 3 and Day 4
Secondary	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)	Pre-dose, on Day 1, Day 2, Day 3 and Day 4
Secondary	CL	CL: Total body clearance of drug	Pre-dose, on Day 1, Day 2, Day 3 and Day 4
Secondary	CL/bw	CL/bw: Total body clearance of drug normalized by body weight	Pre-dose, on Day 1, Day 2, Day 3 and Day 4.

External Links

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