Trial reportJapanese journal of radiology2025
Pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers.
Trial report in Japanese journal of radiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
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Abstract
purposeThe aim of this study was to evaluate the pharmacokinetics and safety of gadopiclenol in Japanese healthy volunteers. A population-based pharmacokinetic approach was used to compare pharmacokinetic parameters with a non-Japanese adult population. MATERIALS AND
methodsIn this double-blind, placebo-controlled phase I study, Japanese healthy volunteers were randomized to receive gadopiclenol (at 0.025, 0.05, or 0.1 mmol/kg) or a placebo. Blood and urine samples were collected up to 24- and 48-h post-administration, respectively. The pharmacokinetic profile of gadopiclenol was evaluated using standard non-compartmental analysis. Adverse events (AEs) were collected during the whole study period.
resultsOverall, 27 participants were randomized (median [range] age: 22 [20-43] years; 52% male): 18 received gadopiclenol (6 in each dose group), and 9 received the placebo. The mean systemic exposure of gadopiclenol increased proportionally with the injected dose (area under the curve [AUC]: 215-1034 μg/mL.h) and was comparable between the three dose groups when normalized to dose (AUC/dose: 182-189 μg/mL/g.h) and to non-Japanese (168-183 μg/mL.h). The mean terminal half-life (1.43-1.86 h), and the distribution volume (11.3-15.2 L) were also similar to those of non-Japanese healthy volunteers (1.50-1.73 h and 13.0-15.5 L, respectively). The mean fraction of gadopiclenol excreted in urine was between 87 and 95%, depending on the administered dose. Most of gadopiclenol (median of 95.7%) was excreted within 24 h after administration. The mean total clearance was comparable between the different administered doses (5.3-5.6 L/h) and similar to the mean renal clearance. No gadopiclenol-related AEs were reported.
conclusionsThe pharmacokinetic profile of gadopiclenol is similar in Japanese and non-Japanese healthy volunteers. The population pharmacokinetic analysis showed no significant ethnic disparities between these two populations and suggested that no dose adjustment was required for Japanese patients. Gadopiclenol had a very good tolerability in Japanese healthy volunteers with no adverse reactions reported.
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