Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT04441255
The purpose of this study is to characterize the effect of a high-fat meal on the PK of TAK-788 administered in healthy participants.
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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
The drug being tested in this study is called TAK-788. The study will characterize the effect of a high-fat meal on the PK of TAK-788 administered in healthy participants.
The study will enroll approximately 14 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment sequence
All participants will be asked to take capsules of assigned TAK-788 on Day 1 of each period.
This single-center trial will be conducted in the United States. The overall time to participate in this study is 61 days. Participants will be contacted by telephone for 30 days after the last dose of study drug for a follow-up assessment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to the first dosing.
Acetaminophen (up to 2 gram per 24 hour period) may be permitted during the study, only after initial dosing, if necessary, to treat adverse events (AEs).
o Any drugs known to be inhibitors or inducers of Cytochrome P450 (CYP3A) enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing and throughout the study.
TAK-788 Capsule.
Other names: AP32788, Mobocertinib
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Takeda
Industry
A Phase 1, Randomized, 2-Period, 2-Sequence, Crossover Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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