Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
Status:
Completed
Trial end date:
2021-07-27
Target enrollment:
Participant gender:
Summary
This single center, single ascending dose, double blind, randomized, placebo-controlled phase
I trial will include male and female Japanese healthy volunteers. Within a 4-week run-in
period before inclusion in the trial, healthy volunteers will be checked for
inclusion/non-inclusion criteria and will then be randomized and administered with
gadopiclenol or placebo. For each healthy volunteer, there will be a confinement period of
one night before the inclusion visit and 2 days post administration at the clinical unit. The
healthy volunteers will return to the clinical unit for safety visit 7 days after study
product administration.
In each dose group, 6 healthy volunteers (3 male and 3 female) will receive gadopiclenol and
3 healthy volunteers (2M/1F or 1M/2F) will receive placebo (physiological saline solution,
0.9% sodium chloride) in one single intravenous administration.
Dose escalation from one group to the next group will be sequential and will be allowed only
if the clinical and biological safety of all healthy volunteers from the previous tested dose
is acceptable. The decision will be made by a Trial Safety Review Board (TSRB), consisting in
members of Guerbet team and the principal investigator.