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The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence ABC | Experimental | Participants will be administered sotorasib orally in the following order: Period 1 - as 1 tablet (test 1) Period 2 - as 2 tablets (reference) Period 3 - as 1 tablet (test 2) |
|
| Treatment Sequence BAC | Experimental | Participants will be administered sotorasib orally in the following order: Period 1 - as 2 tablets (reference) Period 2 - as 1 tablet (test 1) Period 3 - as 1 tablet (test 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotorasib | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4) | |
| Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4) | |
| Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of each period (Days 1 and 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as an adverse event (AE) that started during or after dosing, or started prior to dosing and increased in severity after dosing within each period. Clinically significant laboratory tests, 12-lead electrocardiogram (ECG), or vital sign results as assessed by the Investigator were also recorded as adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit - Daytona Beach | Daytona Beach | Florida | 32117-5116 | United States | ||
| Miami Research Associates LLC - Main Campus / Late Phase |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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A total of 146 participants were enrolled with all participants randomized into Treatment Sequences AB and BA, including 14 participants that proceeded to receive Treatment C in the food effect substudy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence AB | Participants received a single oral dose of sotorasib under fasted conditions in the following order: Period 1 - as 1 tablet (test 1) on Day 1 Period 2 - as 2 tablets (reference) on Day 4 |
| FG001 | Treatment Sequence BA | Participants received a single oral dose of sotorasib under fasted conditions in the following order: Period 1 - as 2 tablets (reference) on Day 1 Period 2 - as 1 tablet (test 1) on Day 4 |
| FG002 | Treatment Sequence ABC | Participants who received treatment sequence AB in Periods 1 & 2 proceeded to receive a single oral dose of sotorasib administered as 1 tablet with a high-fat meal in Period 3 on Day 7. |
| FG003 | Treatment Sequence BAC | Participants who received treatment sequence BA in Periods 1 & 2 proceeded to receive a single oral dose of sotorasib administered as 1 tablet with a high-fat meal in Period 3 on Day 7. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Periods 1 & 2 |
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| Period 3 (Food Effect Substudy) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence AB | Participants received a single oral dose of sotorasib under fasted conditions in the following order: Period 1 - as 1 tablet (test 1) on Day 1 Period 2 - as 2 tablets (reference) on Day 4 |
| BG001 | Treatment Sequence BA |
| 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 | Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib | All participants who received at least 1 dose of sotorasib and had evaluable PK data and evaluable observations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4) |
|
Day 1 to Day 9
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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 | Treatment A | All participants who received a single oral dose of sotorasib under fasted conditions as 1 tablet in either Period 1 or Period 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.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 | Feb 18, 2022 | Mar 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2022 | Mar 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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| Day 1 to Day 9 |
| Period 3: Cmax of Sotorasib | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7) |
| Period 3: AUClast of Sotorasib | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of Period 3 (Day 7) |
| Period 3: AUCinf of Sotorasib | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7) |
| South Miami |
| Florida |
| 33143-5026 |
| United States |
| Labcorp Clinical Research Unit - Dallas | Dallas | Texas | 75247-4989 | United States |
| Labcorp Clinical Research Unit - Madison | Madison | Wisconsin | 53704-2526 | United States |
| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
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Participants received a single oral dose of sotorasib under fasted conditions in the following order: Period 1 - as 2 tablets (reference) on Day 1 Period 2 - as 1 tablet (test 1) on Day 4 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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|
|
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| Primary | Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib | All participants who received at least 1 dose of sotorasib and had evaluable PK data and evaluable observations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4) |
|
|
|
|
| Primary | Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib | All participants who received at least 1 dose of sotorasib and had evaluable PK data and evaluable observations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of each period (Days 1 and 4) |
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|
|
|
| Secondary | Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as an adverse event (AE) that started during or after dosing, or started prior to dosing and increased in severity after dosing within each period. Clinically significant laboratory tests, 12-lead electrocardiogram (ECG), or vital sign results as assessed by the Investigator were also recorded as adverse events. | Posted | Count of Participants | Participants | Day 1 to Day 9 |
|
|
|
| Secondary | Period 3: Cmax of Sotorasib | All participants who received at least 1 dose of sotorasib and had evaluable PK data and evaluable observations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7) |
|
|
|
| Secondary | Period 3: AUClast of Sotorasib | All participants who received at least 1 dose of sotorasib and had evaluable PK data and evaluable observations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of Period 3 (Day 7) |
|
|
|
| Secondary | Period 3: AUCinf of Sotorasib | All participants who received at least 1 dose of sotorasib and had evaluable PK data and evaluable observations. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7) |
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|
|
| 0 |
| 146 |
| 0 |
| 146 |
| 3 |
| 146 |
| EG001 | Treatment B | All participants who received a single oral dose of sotorasib under fasted conditions as 2 tablets in either Period 1 or Period 2. | 0 | 146 | 0 | 146 | 10 | 146 |
| EG002 | Treatment C | All participants who received a single oral dose of sotorasib as 1 tablet with a high-fat meal in Period 3. | 0 | 14 | 0 | 14 | 0 | 14 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.