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Purpose  Recombinant  hCG  (r‐ hCG ) was approved in Japan in 2016. As a prerequisite for a Phase  III  study in Japan related to this approval, the pharmacokinetic ( PK ) profile of r‐ hCG  was investigated.    Methods  An open‐label, partly randomized, single‐center, single‐dose, group‐comparison, Phase I  PK ‐bridging study was done that compared a single 250 μg dose of r‐ hCG  with a single 5000  IU  dose of urinary  hCG  (u‐ hCG ) in healthy Japanese women, as well as comparing a single 250 μg dose of r‐ hCG  in Japanese and Caucasian women. The Japanese participants were randomized 1:1 to receive either r‐ hCG  or u‐ hCG , while the Caucasian participants were weight‐matched to the Japanese participants who were receiving r‐ hCG  in a 1:1 fashion. The primary  PK  parameters were the area under the serum concentration–time curve from time 0 extrapolated to infinity ( AUC  0–∞ ) and the maximum serum concentration (C max ).    Results  The mean serum  hCG  concentration–time profiles of r‐ hCG  in the Japanese and Caucasian participants were a similar shape, but the level of overall exposure was ~20% lower in the Japanese participants. For the Japanese participants, r‐ hCG  resulted in an 11% lower C max  but a 19% higher  AUC  0–∞  compared with u‐ hCG . No new safety signal was identified.    Conclusion  This study cannot exclude a potential difference in the  PK  profile of r‐ hCG  between Japanese and Caucasian participants. However, this study does not indicate that there are clinically relevant differences in the serum  PK  of r‐ hCG  and u‐ hCG  in the Japanese participants.

reproductive medicine and biology

Single‐dose pharmacokinetic study comparing the pharmacokinetics of recombinant human chorionic gonadotropin in healthy Japanese and Caucasian women and recombinant human chorionic gonadotropin and urinary human chorionic gonadotropin in healthy Japanese women