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健康成人におけるS-648414の単回および複数回投与時の安全性、忍容性、薬物動態、薬物相互作用および食物相互作用の評価

基本情報

NCT ID
NCT04147715
ステータス
完了
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
98
治験依頼者名
Shionogi Inc.

概要

The primary objective of Part 1 of the study is to evaluate the safety and tolerability of S-648414 after administration of a single oral dose of S-648414 in healthy adult study participants. The primary objective of Part 2 is to evaluate the safety and tolerability of S-648414 after administration of multiple oral doses of S-648414 in healthy adult study participants. The primary objectives of Part 3 are evaluate the safety and tolerability of S-648414 after administration of multiple oral doses of S-648414 in healthy adult study participants, and to evaluate the effect of S-648414 on the pharmacokinetics (PK) of dolutegravir and the effect of dolutegravir on the PK of S-648414 in healthy adult study participants.

対象疾患

Healthy Volunteer

介入

S-648414(DRUG)
Placebo(DRUG)
Midazolam(DRUG)
Dolutegravir(DRUG)

依頼者(Sponsor)

実施施設 (1)

P-One Clinic

Hachiōji, Toyko, Japan