A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: TAK-788

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TAK-788 160 mg Fasted + TAK-788 160 mg Fed; TAK-788 160 milligram (mg), capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).	Drug: TAK-788; TAK-788 Capsule.; Other Names: AP32788; Mobocertinib
EXPERIMENTAL: TAK-788 160 mg Fed + TAK-788 160 mg Fasted; TAK-788 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).	Drug: TAK-788; TAK-788 Capsule.; Other Names: AP32788; Mobocertinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
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	Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ACTUAL): August 10, 2020
• Study Completion (ACTUAL): August 10, 2020

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (ACTUAL): June 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Drug Therapy
• Other Study ID Numbers: TAK-788-1005; CA24171 (OTHER: Celerion)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No