Study to compare the levels of IPN60170 (mesdopetam) in blood in healthy Japanese, Chinese and Non-Asian participants after administration of two different doses of IPN60170
This Phase 1 study is part of the global development plan, which includes plans to seek marketing approval of IPN60170 in Japan and China. The Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the National Medical Products Administration (NMPA) in China request that the full pharmacokinetic (PK) profile of a new drug entity be assessed in Japanese and Chinese healthy participants before it is administered to Japanese and Chinese patients in efficacy and safety trials, respectively. This Phase 1 study is intended to assess the PK of single IPN60170 doses of 2.5 and 7.5 mg in healthy adult Japanese and Chinese participants in order to support inclusion of Japanese and Chinese patients with Parkinson’s Disease (PD) in the planned Phase 3 Studies. To this end, the current study is conducted as a PK race/ethnic sensitivity study comparing the PK profiles of IPN60170 in healthy Japanese, Chinese and Non-Asian participants.
Study to compare the levels of IPN60170 (mesdopetam) in blood in healthy Japanese, Chinese and Non-Asian participants after administration of two different doses of IPN60170
This Phase 1 study is part of the global development plan, which includes plans to seek marketing approval of IPN60170 in Japan and China. The Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the National Medical Products Administration (NMPA) in China request that the full pharmacokinetic (PK) profile of a new drug entity be assessed in Japanese and Chinese healthy participants before it is administered to Japanese and Chinese patients in efficacy and safety trials, respectively. This Phase 1 study is intended to assess the PK of single IPN60170 doses of 2.5 and 7.5 mg in healthy adult Japanese and Chinese participants in order to support inclusion of Japanese and Chinese patients with Parkinson’s Disease (PD) in the planned Phase 3 Studies. To this end, the current study is conducted as a PK race/ethnic sensitivity study comparing the PK profiles of IPN60170 in healthy Japanese, Chinese and Non-Asian participants.
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