drugset / Trial / NCT03297983
M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TL-895 | Small molecule | — | Oral |
Indications
No indication recorded.