drugset / Trial / NCT03297983

M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule

NCT03297983

Phase 1 Completed 18 enrolled Merck KGaA, Darmstadt, Germany
RandomizedCrossoverOpen-labelOther

Summary

This is a Phase I study consisting of 2 parts: Part 1 aims to investigate the relative bioavailability of tablet formulation (test treatment) and Powder in capsule (PiC) formulation (reference treatment) of M7583 under fasted conditions. The aim of Part 2 is to determine and compare the single dose Pharmacokinetic (PK) profile of M7583 tablet under fasted and fed conditions to assess the food effect.

Timeline

Start
2017-10-09
Primary completion
2017-12-06
Completion
2017-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject TL-895 Small molecule Oral

Indications

No indication recorded.