At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Midazolam and TAK-788 for Carcinoma, Non-Small-Cell Lung and Lung Neoplasms. Completed, enrolled 26 participants across 8 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung, Lung Neoplasms
CountriesAustralia, Netherlands, Singapore
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartDec 2019
Primary CompletionDec 2020
Study CompletionDec 2021
TodayJul 2026
First PostedAug 9, 2019
Enrollment StartDec 23, 2019
Primary CompletionDec 17, 2020
Study CompletionDec 7, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.9 years ago
Interventions
Midazolamdrug
Midazolam Oral Solution and Midazolam Intravenous Infusion.
TAK-788drug
TAK-788 Oral Capsules.