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drugset / Trial / NCT04619251

A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood

NCT04619251 ↗

Phase 1 Completed 74 enrolled Boehringer Ingelheim
RandomizedSequentialSingle-blindTreatment

Summary

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.

Timeline

Start
2020-11-13
Primary completion
2021-07-30
Completion
2021-08-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 1323495 Unknown 10 mg Oral
Subject BI 1323495 Unknown 30 mg Oral
Subject BI 1323495 Unknown 60 mg Oral
Subject BI 1323495 Unknown 70 mg Oral
Subject BI 1323495 Unknown 100 mg Oral
Subject BI 1323495 Unknown 150 mg Oral
Background Itraconazole Small molecule 200 mg Oral

Indications

No indication recorded.