check_circleStudy Completed

Contrast enhancement in magnetic resonance imaging, Healthy volunteers

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

Trial purpose

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).

Key Participants Requirements

Sex

Male

Age

20 - 40 Years

Trial summary

Enrollment Goal
25
Trial Dates
April 2019 - July 2019
Phase
Phase 1
Could I Receive a placebo
No
Products
Gadoquatrane (BAY1747846)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
SOUSEIKAI Fukuoka Mirai HospitalFukuoka, 813-0017, Japan

Primary Outcome

  • Number of participants with treatment-emergent adverse events
    date_rangeTime 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.)
  • Severity of treatment-emergent adverse events
    date_rangeTime 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.)

Secondary Outcome

  • Maximum observed drug concentration in measured matrix after single dose administration (Cmax)
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
  • Total body clearance of drug (CL)
    date_rangeTime Frame:
    Pre-dose, on Day 1, Day 2, Day 3 and Day 4.
  • Total body clearance of drug normalized by body weight (CL/bw)
    date_rangeTime Frame:
    Pre-dose, on Day 1, Day 2, Day 3 and Day 4.

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2