Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title: A Phase 1, Open-Label, Multicenter, Drug-Drug Interaction Study of TAK-788 and Midazolam, a Sensitive CYP3A Substrate, in Patients With Advanced Non-Small Cell Lung Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to characterize the effect of repeated oral administration of TAK-788 160 milligram (mg) once daily on the single oral and intravenous dose pharmacokinetics (PK) of midazolam.

Clinical Trial Description

The drug being tested in this study is called TAK-788. The study will characterize the effect of repeated oral administration of TAK-788 160 mg on the single oral- and intravenous-dose PK of midazolam, and will assess the safety and tolerability of TAK-788 in participants with advanced NSCLC.

The study will enroll approximately 26 participants. The study will be conducted in 2 parts:

Part A (Cycle 1: PK Cycle) and Part B (Cycle 2 to Cycle 24: Treatment Cycles). In Part A, participants will receive midazolam as an oral dose and intravenous infusion, along with oral dose of TAK-788 in a single 30-day cycle. After completion of Part A, eligible participants may enter Part B. In Part B, participants will continue to receive oral dose of TAK-788 that they were receiving and tolerating at the end of Part A in a 28-day treatment cycle for up to 23 cycles of treatment, or until progressive disease (PD), intolerable toxicity, or another discontinuation criterion is met. Based on the opinion of investigator, if a participant continue to experience clinical benefit, treatment with TAK-788 may be continued after PD.

This multi-center trial will be conducted in Australia, Singapore and the Netherlands. The overall time to participate in this study is 3 years. Participants will make multiple visits to the clinic and will be followed up for 30 days after the last dose of study drug for a follow-up assessment. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

• NCT number: NCT04051827
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: December 23, 2019
• Completion date: December 7, 2021