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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04441255

Enrollment

Registered

2020-06-22

Start date

2020-07-01

Completion date

2020-08-10

Last updated

2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Drug Therapy

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.

Interventions

DRUGTAK-788

TAK-788 Capsule.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

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

Countries

United States

Participant flow

Recruitment details

Participants took part in the study at 1 investigative site in the United States from 01 July 2020 to 10 August 2020.

Pre-assignment details

Healthy participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive mobocertinib (TAK-788) 160 milligram (mg), capsule, in fasted condition (Treatment A) or mobocertinib 160 mg, capsule, in fed condition (Treatment B).

Participants by arm

Arm	Count
Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).	7
Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).	7
Total	14

Baseline characteristics

Characteristic	Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted	Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed	Total
Age, Continuous	35.4 years STANDARD_DEVIATION 9.14	34.0 years STANDARD_DEVIATION 9.61	34.7 years STANDARD_DEVIATION 9.04
Body Mass Index (BMI)	24.706 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.2743	24.293 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.0143	24.499 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.0311
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants	7 Participants	13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Height	175.6 centimeter (cm) STANDARD_DEVIATION 13.5	174.3 centimeter (cm) STANDARD_DEVIATION 9.48	174.9 centimeter (cm) STANDARD_DEVIATION 11.23
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	5 Participants	5 Participants	10 Participants
Region of Enrollment United States	7 Participants	7 Participants	14 Participants
Sex: Female, Male Female	2 Participants	2 Participants	4 Participants
Sex: Female, Male Male	5 Participants	5 Participants	10 Participants
Weight	76.70 kilogram (kg) STANDARD_DEVIATION 16.416	73.89 kilogram (kg) STANDARD_DEVIATION 11.879	75.29 kilogram (kg) STANDARD_DEVIATION 13.843

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 14
other Total, other adverse events	5 / 14	6 / 14
serious Total, serious adverse events	0 / 14	0 / 14