Clinical trial NCT04441255: A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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

* TAK-788 160 mg Fasted (Reference) in Period 1 + TAK-788 160 mg Fed (Test) in Period 2
* TAK-788 160 mg Fed (Test) in Period 1 + TAK-788 160 mg Fasted (Reference) in Period 2

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Body mass index (BMI) greater than or equal to (\>=) 18.5 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2), at screening.
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiogram (ECGs), as deemed by the Investigator or designee.

Exclusion Criteria:

1. History of any illness (including hyperlipidemia and diabetes since high fat meal is required) that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
2. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
3. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
4. History or presence of any previous lung disease and/or current lung infection.
5. Positive urine drug or alcohol results at screening or first check-in.
6. Positive results at screening for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
7. Positive test result for active coronavirus disease 2019 (COVID-19).
8. Seated blood pressure is less than (\<) 90/40 millimeter of mercury of mercury (mmHg) or greater than 140/90 mmHg at screening.
9. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
10. QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is greater than (\>) 460 millisecond (msec) (males) or \>470 msec (females) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening.
11. Creatinine clearance \<90 milliliter per minute (mL/min) at screening (calculated using the Cockcroft-Gault formula).
12. 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.
13. 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.
14. Donation of blood or significant blood loss within 56 days prior to the first dosing.
15. Plasma donation within 7 days prior to the first dosing.

Primary outcomes:
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Secondary outcomes:
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: 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
timeFrame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: