Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 1, Open-Label Study to Assess the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of TAK-931 in Patients With Advanced Solid Tumors
Study ID: NCT03708211
Conditions
Study Description
Brief 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.
Detailed Description: The drug being tested in this study is called TAK-931. TAK 931 is being tested to treat participants who have advanced solid tumors. This study will look at relative bioavailability, effect of food and gastric pH modification on the PK of TAK-931. The study will enroll approximately 44 participants. The study will be conducted in 2 parts: Part 1 and Part 2. In Part 1 and Part 2, participants will be randomly assigned (by chance, like flipping a coin) in a crossover design. In Part 1, participants will be assigned to 1 of the 2 following treatment sequences: * TAK-931 80 mg PIC + TAK-931 80 mg Tablet * TAK-931 80 mg Tablet + TAK-931 80 mg PIC Part 2 of the study will be initiated, once the preliminary PK data from Part 1 is available to determine the relative bioavailability of the tablet formulation in reference to PIC and to calculate the single dose of TAK-931 tablet to be used in Part 2.In Part 2, participants will be assigned to 1 of the 2 following treatment sequences: * TAK-931 TBD Fed + TAK-931 TBD Fasted * TAK-931 TBD Fasted + TAK-931 TBD Fed This multi-center trial will be conducted in the Netherlands. The overall time to participate in this study is approximately 2 years. Participants will make multiple visits to the clinic and will be contacted for approximately 30 days after receiving their last dose of study drug or until the start of subsequent anticancer therapy, whichever occurs first for a follow up assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Radboud University Medical Center, Department of Medical Oncology, Nijmegen, Gelderland, Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek, Department of Medical Oncology, Amsterdam, Noord-holland, Netherlands
Leiden University Medical Center, Department of Clinical Oncology, Leiden, Zuid-holland, Netherlands
Erasmus MC Cancer Institute, Department of Internal Oncology, Rotterdam, Zuid-holland, Netherlands
Contact Details
Name: Medical Director
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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