A Phase 1 interventional study of gadopiclenol and Placebo in Pharmacokinetics, sponsored by Guerbet. Completed at 1 site in Japan. Open to participants aged 20 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Guerbet · Phase 1, Interventional, and Other
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.
Guerbet is the lead sponsor of 41 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose per administration: dose/volume of gadopiclenol to be administered will be calculated based on patient's weight at the dose of 0.025; 0.05 or 0.1 mmol/kg BW (depending on each group). 6 volunteers will receive gadopiclenol per group
Drug: gadopiclenol
Dose per administration: similar dose (Volume/weight) as the one used for Gadopiclenol in the considered group. 3 volunteers will receive gadopiclenol per group
Drug: Placebo
administration by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a saline flush of at least 5 mL at the same rate to ensure complete injection of the contrast agent.The gadopiclenol administration is performed by power injecto
intravenous (IV) bolus injection at 2 mL/s, followed by a saline flush of at least 5 mL to be in the same conditions as for gadopiclenol administration.The gadopiclenol administration is performed by power injector
Cmax
Maximum concentrations measured, value taken directly from the observed concentration-time profiles
Time frame: from baseline (30 minutes before injection) to 24hours post injection
Tmax
Time corresponding to Cmax
Time frame: from baseline (30 minutes before injection) to 24hours post injection
AUC 0-inf
Area Under the observed concentration-time Curve from zero (time of drug administration) to infinity with extrapolation of the terminal phase. It will be obtained as follows: AUC 0-inf = AUC 0-T last + (Clast / β)
Time frame: from baseline (30 minutes before injection) to 24hours post injection
t 1/2β
Terminal elimination half-life of gadopiclenol calculated as follows: t 1/2β = ln 2 / β
Time frame: from baseline (30 minutes before injection) to 24hours post injection
AUC extrap%
Percentage of extrapolation of AUC from the last observation (Tlast) to infinity calculated as follows: Percentage of extrapolation of AUC from the last observation (Tlast) to infinity calculated as follows: Percentage of extrapolation of AUC from the last observation (Tlast) to infinity calculated as follows:
Time frame: from baseline(30 minutes before injection) to 24hours post injection
CLT
Total Clearance, calculated as CLT = Dose /AUC 0-inf
Time frame: from baseline (30 minutes before injection) to 24hours post injection
Vdβ
Volume of distribution, calculated as Vdβ = Dose / (AUC 0-inf x β)
Time frame: from baseline (30 min before injection) to 24h post injection
Ae
Total amount of gadopiclenol excreted in urine
Time frame: Before administration and during intervals 0-6hours, 6-24hours and 24-48hours after gadopiclenol administration
CLR
Renal clearance, calculated as CLR = Ae / AUC 0-inf
Time frame: Before administration and during intervals0-6hours, 6-24hours and 24-48hours after gadopiclenol administration
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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