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日本人健康男性ボランティアを対象としたGSK2330672の用量漸増試験

基本情報

NCT ID
NCT02801981
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
16
治験依頼者名
GlaxoSmithKline

概要

This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled, dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy subjects. Study will be conducted in four periods; subjects will receive either placebo or GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period. Each period will be separated by washout period (at least 6 days from dosing). Total duration of study for each subject will be approximately 5 weeks from the first dosing to follow up visit.

対象疾患

Cholestasis

介入

GSK2230672(DRUG)
Placebo(DRUG)

依頼者(Sponsor)

実施施設 (1)

GSK Investigational Site

Tokyo, Japan