A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib |
6.01; 8.00 | — |
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Mobocertinib |
56.8; 56.6 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib |
1030; 1230 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib |
1020; 1210 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib |
6.00; 8.00; 6.01; 8.00 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib |
31.1; 27.7; 4.34; 3.73 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib |
704; 731; 79.4; 89.2 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib |
682; 709; 69.2; 72.2 | — |
Eligibility Criteria
Inclusion Criteria
- Continuous non-smoker who has not used nicotine-containing products for at least 20 years prior to the first dosing and throughout the study, based on participant self-reporting.
- Body mass index (BMI) greater than or equal to (>=) 18.5 and less than or equal to ( ) 460 millisecond (msec) (males) or >470 msec (females) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
- Creatinine clearance <90 milliliter per minute (mL/min) at screening (calculated using the Cockcroft-Gault formula).
- Unable to refrain from or anticipates the use of:
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.
- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
Data sourced from ClinicalTrials.gov (NCT04441255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.