A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors

Phase 1 Completed 20 enrolled Millennium Pharmaceuticals, Inc.

RandomizedCrossoverOpen-labelOther

Summary

The purpose of this study is to estimate the relative bioavailability of TAK-931 tablets in reference to powder-in capsule (PIC) and to assess the effect of food and esomeprazole on the pharmacokinetics (PK) of TAK-931 as a tablet.

Timeline

Start: 2019-03-28
Primary completion: 2019-12-03
Completion: 2019-12-03

Publications

Steeghs N, Pruis M, van Herpen C, Lu V, Redman J, Zhou X. A phase 1 open-label study to assess the relative bioavailability of TAK-931 tablets in reference to powder-in-capsule in patients with advanced solid tumors. Invest New Drugs. 2023 Feb;41(1):53-59. doi: 10.1007/s10637-022-01318-3. Epub 2022 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esomeprazole	Small molecule	40 mg	Oral
Subject	SIMUROSERTIB	Small molecule	50 mg	Oral

A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications