Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants (NCT NCT05048784)

Last Updated: 2023-09-18

Results Overview

Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma pharmacokinetic (PK) parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

145 participants

Primary outcome timeframe

Predose (Hour 0), 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 Day 1 (Period 1) and Day 4 (Period 2)

Results posted on

2023-09-18

Participant Flow

Overall, 145 participants were enrolled in the study in the United States between 16 August 2021 and 18 February 2022.

After randomization, participants received Treatment A (test 1) and Treatment B (reference) according to the treatment sequence assigned. A group of participants from both arm proceeded to receive Treatment C (test 2) with a high-fat meal. Dose administration of sotorasib occurred on Day 1 (Period 1) and Day 4 (Period 2) under fasted conditions and on Day 7 (Period 3) under fed condition.

Participant milestones

Participant milestones
Measure	Treatment Sequence AB Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment A as 3 tablets (test 1). * Period 2: Treatment B as 8 tablets (reference).	Treatment Sequence BA Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment B as 8 tablets (reference). * Period 2: Treatment A as 3 tablets (test 1).	Treatment Sequence ABC Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment A as 3 tablets (test 1). * Period 2: Treatment B as 8 tablets (reference). * Period 3: Treatment C as 3 tablets with a high-fat meal (test 2).	Treatment Sequence BAC Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment B as 8 tablets (reference). * Period 2: Treatment A as 3 tablets (test 1). * Period 3: Treatment C as 3 tablets with a high-fat meal (test 2).
Period 1 STARTED	66	66	6	7
Period 1 Administered Treatment A	66	0	6	0
Period 1 Administered Treatment B	0	66	0	7
Period 1 COMPLETED	63	65	6	7
Period 1 NOT COMPLETED	3	1	0	0
Period 2 STARTED	63	65	6	7
Period 2 Administered Treatment A	0	65	0	7
Period 2 Administered Treatment B	63	0	6	0
Period 2 COMPLETED	63	64	6	7
Period 2 NOT COMPLETED	0	1	0	0
Period 3 STARTED	0	0	6	7
Period 3 Administered Treatment C	0	0	6	7
Period 3 COMPLETED	0	0	6	7
Period 3 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Sequence AB Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment A as 3 tablets (test 1). * Period 2: Treatment B as 8 tablets (reference).	Treatment Sequence BA Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment B as 8 tablets (reference). * Period 2: Treatment A as 3 tablets (test 1).	Treatment Sequence ABC Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment A as 3 tablets (test 1). * Period 2: Treatment B as 8 tablets (reference). * Period 3: Treatment C as 3 tablets with a high-fat meal (test 2).	Treatment Sequence BAC Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment B as 8 tablets (reference). * Period 2: Treatment A as 3 tablets (test 1). * Period 3: Treatment C as 3 tablets with a high-fat meal (test 2).
Period 1 Adverse Event	3	1	0	0
Period 2 Lost to Follow-up	0	1	0	0

Baseline Characteristics

A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Sequence AB n=66 Participants Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment A as 3 tablets (test 1). * Period 2: Treatment B as 8 tablets (reference).	Treatment Sequence BA n=66 Participants Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment B as 8 tablets (reference). * Period 2: Treatment A as 3 tablets (test 1).	Treatment Sequence ABC n=6 Participants Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment A as 3 tablets (test 1). * Period 2: Treatment B as 8 tablets (reference). * Period 3: Treatment C as 3 tablets with a high-fat meal (test 2).	Treatment Sequence BAC n=7 Participants Participants were administered 960 mg sotorasib orally in the following order: * Period 1: Treatment B as 8 tablets (reference). * Period 2: Treatment A as 3 tablets (test 1). * Period 3: Treatment C as 3 tablets with a high-fat meal (test 2).	Total n=145 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants	66 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	145 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	60 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	130 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	31 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	63 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	35 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	82 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	26 Participants n=5 Participants	30 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	60 Participants n=21 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	34 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	82 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Predose (Hour 0), 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 Day 1 (Period 1) and Day 4 (Period 2)

Population: The PK population included all participants who received at least 1 dose of sotorasib in Periods 1 and 2, and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of the Cmax (tmax) or diarrhea within 24 hours of dosing.

Outcome measures

Outcome measures
Measure	Treatment A n=142 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=141 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B	6650 ng/mL Geometric Coefficient of Variation 41.3	6540 ng/mL Geometric Coefficient of Variation 37.3	—

PRIMARY outcome

Timeframe: Predose (Hour 0), 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 Day 1 (Period 1) and Day 4 (Period 2)

Population: The PK population included all participants who received at least 1 dose of sotorasib in Periods 1 and 2, and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing.

Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib. Plasma PK parameters of sotorasib were summarized per treatment received, regardless of treatment sequence, as pre-specified.

Outcome measures

Outcome measures
Measure	Treatment A n=142 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=140 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B	27800 h*ng/mL Geometric Coefficient of Variation 51.1	27500 h*ng/mL Geometric Coefficient of Variation 41.6	—

PRIMARY outcome

Timeframe: Predose (Hour 0), 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 Day 1 (Period 1) and Day 4 (Period 2)

Population: The PK population included all participants who received at least 1 dose of sotorasib in Periods 1 and 2, and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing.

Outcome measures

Outcome measures
Measure	Treatment A n=138 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=138 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B	28600 h*ng/mL Geometric Coefficient of Variation 48.1	27700 h*ng/mL Geometric Coefficient of Variation 41.5	—

SECONDARY outcome

Timeframe: Day 1 to Day 9

Population: The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.

An AE is any untoward medical occurrence in a participant irrespective of a causal relationship with the study treatment. Any abnormal clinical laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., 12-lead electrocardiogram or vital signs measurements), including those that worsen from baseline, that are considered clinically significant in the medical and scientific judgment of the Investigator (i.e., not related to progression of underlying disease) were considered AEs.

Outcome measures

Outcome measures
Measure	Treatment A n=145 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=145 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C n=13 Participants One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Number of Participants Who Experienced a Treatment-emergent AE (TEAE)	8 Participants	10 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose (Hour 0), 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 Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3)

Population: The PK population included all participants who received at least 1 dose of sotorasib in Period 3 and had evaluable PK data. A participant may have been excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 times median tmax or diarrhea within 24 hours of dosing.

Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.

Outcome measures

Outcome measures
Measure	Treatment A n=13 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=13 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C n=13 Participants One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Food Effect: Cmax of Sotorasib	6390 ng/mL Geometric Coefficient of Variation 34.6	6790 ng/mL Geometric Coefficient of Variation 28.9	6400 ng/mL Geometric Coefficient of Variation 19.0

SECONDARY outcome

Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.

Outcome measures

Outcome measures
Measure	Treatment A n=13 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=13 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C n=13 Participants One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Food Effect: AUClast of Sotorasib	23900 h*ng/mL Geometric Coefficient of Variation 40.8	26100 h*ng/mL Geometric Coefficient of Variation 31.1	34500 h*ng/mL Geometric Coefficient of Variation 19.2

SECONDARY outcome

Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.

Outcome measures

Outcome measures
Measure	Treatment A n=12 Participants One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=13 Participants One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C n=13 Participants One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Food Effect: AUCinf of Sotorasib	23500 h*ng/mL Geometric Coefficient of Variation 41.0	26500 h*ng/mL Geometric Coefficient of Variation 30.3	34700 h*ng/mL Geometric Coefficient of Variation 19.2

Adverse Events

Treatment A

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment B

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Treatment C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Treatment A n=145 participants at risk One administration of 960 mg sotorasib administered orally as 3 tablets (test 1) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment B n=145 participants at risk One administration of 960 mg sotorasib administered orally as 8 tablets (reference) in Period 1 or Period 2, depending on treatment sequence assigned.	Treatment C n=13 participants at risk One administration of 960 mg sotorasib administered orally as 3 tablets with a high-fat meal (test 2) in Period 3.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Ear and labyrinth disorders Vertigo	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Gastrointestinal disorders Abdominal pain	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Gastrointestinal disorders Diarrhoea	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Gastrointestinal disorders Faeces discoloured	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Gastrointestinal disorders Nausea	2.1% 3/145 • Number of events 3 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Gastrointestinal disorders Vomiting	1.4% 2/145 • Number of events 2 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
General disorders Influenza like illness	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Infections and infestations Covid-19	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Infections and infestations Furuncle	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Infections and infestations Pharyngitis	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Post procedural contusion	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Investigations Sars-cov-2 test positive	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Nervous system disorders Headache	1.4% 2/145 • Number of events 2 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Nervous system disorders Paraesthesia	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Nervous system disorders Presyncope	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Nervous system disorders Somnolence	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.
Skin and subcutaneous tissue disorders Erythema	0.69% 1/145 • Number of events 1 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/145 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.	0.00% 0/13 • Day 1 to Day 9 The safety population included all participants who received at least 1 dose of sotorasib and had at least 1 postdose safety assessment.