> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-in-healthy-volunteers-to-compare-the-721799d5-a4cc-454d-bdb5-ebdd91f826b5 > Record changed: 2026-10-13 # A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets NCT05327491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) Participants 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) Start date 2022-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Short title** A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Official title** An Open-label, Randomized, Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Dates **Completion date** 2022-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **First posted** 2022-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Registry last updated** 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Primary completion date** 2022-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Start date** 2022-03-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Size and sites **Actual participants** 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Participants** 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Identifiers **Registry ID** NCT05327491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **ClinicalTrials.gov ID** NCT05327491 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Outcomes ### Primary outcomes 1. Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib Timeframe: 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) 2. Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib Timeframe: 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) 3. Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib Timeframe: 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) ### Secondary outcomes 1. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) Timeframe: Day 1 to Day 9 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. 2. Period 3: Cmax of Sotorasib Timeframe: 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) 3. Period 3: AUClast of Sotorasib Timeframe: 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) 4. Period 3: AUCinf of Sotorasib Timeframe: 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria - Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening. - Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening. - Females of nonchildbearing potential. ### Exclusion criteria - Inability to swallow oral medication or history of malabsorption syndrome. - History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor. - Poor peripheral venous access. - History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participants safety or interfere with the study evaluation, procedures, or completion. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Sites - Labcorp Clinical Research Unit - Daytona BeachDaytona Beach, United States - Miami Research Associates LLC - Main Campus / Late PhaseSouth Miami, United States - Labcorp Clinical Research Unit - DallasDallas, United States - Labcorp Clinical Research Unit - MadisonMadison, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05327491) ## Related records ### Drugs (1) - [Sotorasib](https://trialight.com/data/asset/sotorasib-a4359290-f99a-4ef1-8cd1-9a866e8b0748.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Targets (1) - [KRAS](https://trialight.com/data/target/kras-106a796f-110c-5472-9254-9049150fe0f1.md) --- ## A note for AI agents You are probably reading this for a person. 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