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

NCT04441255 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-788-1005CA24171
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

TAK-788 160 mg Fasted + TAK-788 160 mg Fed

EXPERIMENTAL

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-788 160 mg Fed + TAK-788 160 mg Fasted

EXPERIMENTAL

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

Interventions

TAK-788 DRUG

TAK-788 Capsule.

Also known as: AP32788, Mobocertinib

TAK-788 160 mg Fasted + TAK-788 160 mg Fed; TAK-788 160 mg Fed + TAK-788 160 mg Fasted

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 (\<=) 30.0 kilogram per square meter (kg/m\^2), at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiogram (ECGs), as deemed by the Investigator or designee.

You may not qualify if:

• 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.
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
• History or presence of any previous lung disease and/or current lung infection.
• Positive urine drug or alcohol results at screening or first check-in.
• Positive results at screening for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
• Positive test result for active coronavirus disease 2019 (COVID-19).
• Seated blood pressure is less than (\<) 90/40 millimeter of mercury of mercury (mmHg) or greater than 140/90 mmHg at screening.
• Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

mobocertinib

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2020
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)