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| ID | Type | Description | Link |
|---|---|---|---|
| CA24171 | Other Identifier | Celerion |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-788 | Drug | TAK-788 Capsule. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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.
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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.
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 took part in the study at 1 investigative site in the United States from 01 July 2020 to 10 August 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (1 Day) |
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| Washout Period (10 Days) |
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| Period 2 (1 Day) |
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The safety set included all participants who received at least one dose of a study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib | The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Median | Full Range | hours | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mobocertinib 160 mg Fasted | Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2020 | Aug 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2020 | Aug 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000720862 | mobocertinib |
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| 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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
|
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| Primary | Cmax: Maximum Observed Plasma Concentration for Mobocertinib | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| Primary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Median | Full Range | hours | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| Secondary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| 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 | The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 5 |
| 14 |
| EG001 | Mobocertinib 160 mg Fed | Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B). | 0 | 14 | 0 | 14 | 6 | 14 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pustule | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| AP32914 |
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