Belgium-based Mithra Pharmaceuticals and Japan's Fuji Pharma are set to begin a pharmacokinetic (PK) ethnobridging trial of Estelle in Japanese and Caucasian women.
Mithra’s Estelle is an oral contraceptive product candidate formulated with 15mg of estetrol (E4) and 3mg of drospirenone (DRSP).
The single-centre, double-blind, placebo-controlled, randomised trial is designed to compare the PK profile of different dosages of E4, either alone or in combination with DRSP, in 48 Japanese and 48 Caucasian subjects.
The primary objective of the trial is to determine and compare the PK profile following a single oral dose, by examining differences in drug exposure and elimination.
The safety and tolerability of E4 alone, as well as in combination with DRSP will also be assessed.
The trial’s topline results are expected to be available between the fourth quarter of this year and the first quarter of next year.
Mithra Pharmaceuticals chief executive officer François Fornieri said: “We are pleased to start the bridging study with our partner, Fuji Pharma.
“Progressing development to this stage highlights the constructive collaboration with Fuji Pharma, as well as their commitment to the Estelle programme.
“Moreover, this is an essential first step towards bringing Estelle to the Japanese market, and to potentially offer a safer contraceptive alternative to millions of Japanese women.”
Mithra and Fuji Pharma originally entered a partnership in August last year to develop Estelle in Japanese and ASEAN markets.
Estelle is also being studied in Phase III trials in the US, Canada, Europe and Russia.