健康な日本人男性を対象とした、BI 1323495の異なる投与量に対する忍容性と、イトラコナゾールが血中BI 1323495濃度に及ぼす影響を検証する研究

基本情報

NCT ID

NCT04619251

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

74

治験依頼者名

Boehringer Ingelheim

概要

The main objective of the single-rising dose (SRD) part and the multiple rising dose (MD) part is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics (for MD part only) following single rising doses and multiple oral doses of BI 1323495 in healthy male Japanese subjects genotyped as poor metabolizers (PM) and extensive metabolizers (EM) of UGT2B17. The main objective of the drug-drug interaction (DDI) part is to investigate the relative bioavailability of a single oral dose of BI 1323495 when given alone (treatment R) or in combination with itraconazole (treatment T) in healthy male subjects genotyped as PM of UGT2B17.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)