Healthy ParticipantsPhase 1NCT05048784

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

A Phase 1 study testing Sotorasib in people with Healthy Participants, run by Amgen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Sotorasib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 2 sitesUnited States
Study dates: 16 Aug 2021to 18 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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 participant safety or interfere with the study evaluation, procedures, or completion.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Covance Clinical Research Unit
Dallas, Texas, 75247
Covance Clinical Research Unit
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: An Open-label, Randomized, Two-way Crossover, Bioequivalence Study in Healthy Volunteers to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib

Conditions: Healthy Participants
Being tested: Sotorasib
Keywords: Sotorasib, AMG 510, Bioequivalence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SotorasibDrug
Also called AMG 510
Oral tablet

Study groups in NCT05048784
Study group	Role	What they receive
Treatment Sequence ABC	Experimental	Participants will be administered sotorasib dose A orally in the following order: * Treatment A - as 3 tablets (test 1) * Treatment B - as 8 tablets (reference) * Treatment C - as 3 tablets (test 2) Receives: Drug: Sotorasib
Treatment Sequence BAC	Experimental	Participants will be administered sotorasib dose A orally in the following order: * Treatment B - as 8 tablets (reference) * Treatment A - as 3 tablets (test 1) * Treatment C - as 3 tablets (test 2) Receives: Drug: Sotorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B
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.
Measured: 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)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B
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.
Measured: 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)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B
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.
Measured: 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)

Secondary outcomes (4)

Number of Participants Who Experienced a Treatment-emergent AE (TEAE)
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.
Measured: Day 1 to Day 9
Food Effect: Cmax of Sotorasib
Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.
Measured: 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)
Food Effect: AUClast of Sotorasib
Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.
Measured: 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)
Food Effect: AUCinf of Sotorasib
Blood samples were collected by venipuncture or cannulation for measurement of plasma concentrations of sotorasib.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202118 Feb 2022

First posted17 Sep 2021
Study start16 Aug 2021
Primary completion18 Feb 2022
Study completion18 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05048784
Sponsor's protocol ID: 20210093
Status last verified: Nov 2022
First submitted: 9 Sep 2021
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Two-way Crossover, Bioequivalence Study in Healthy Volunteers to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib
ClinicalTrials.gov ID: NCT05048784
Acronym / sponsor ID: 20210093
Conditions: Healthy Participants
Keywords: Sotorasib, AMG 510, Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 16 Aug 2021 (actual)
Primary completion: 18 Feb 2022 (actual)
Study completion: 18 Feb 2022 (actual)
First posted: 17 Sep 2021 (actual)
Results: Posted 18 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment Sequence ABC	Experimental	Drug: SotorasibParticipants will be administered sotorasib dose A orally in the following order: * Treatment A - as 3 tablets (test 1) * Treatment B - as 8 tablets (reference) * Treatment C - as 3 tablets (test 2)
Treatment Sequence BAC	Experimental	Drug: SotorasibParticipants will be administered sotorasib dose A orally in the following order: * Treatment B - as 8 tablets (reference) * Treatment A - as 3 tablets (test 1) * Treatment C - as 3 tablets (test 2)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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 participant safety or interfere with the study evaluation, procedures, or completion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SotorasibAlso: AMG 510Oral tablet	Drug	Treatment Sequence ABC, Treatment Sequence BAC

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B
Time frame: 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)
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B
Time frame: 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)
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B
Time frame: 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)
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.

4 secondary outcomes

Number of Participants Who Experienced a Treatment-emergent AE (TEAE)
Time frame: Day 1 to Day 9
Food Effect: Cmax of Sotorasib
Time frame: 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)
Food Effect: AUClast of Sotorasib
Time frame: 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)
Food Effect: AUCinf of Sotorasib
Time frame: 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)

Results and safety

Results posted to the registry on 18 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence AB	66	63
Treatment Sequence BA	66	65
Treatment Sequence ABC	6	6
Treatment Sequence BAC	7	7

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B

Time frame: 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). Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A n = 142	Treatment B n = 141
Value	6650 (41.3)	6540 (37.3)

Treatment A vs Treatment B: Ratio of geometric least squares means: 1.009 (90% CI 0.980 to 1.040)

Population analysed: 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.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib for Treatments A and B

Measure	Treatment A n = 142	Treatment B n = 140
Value	27800 (51.1)	27500 (41.6)

Treatment A vs Treatment B: Ratio of geometric least squares means: 1.010 (90% CI 0.967 to 1.055)

Population analysed: 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.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Sotorasib for Treatments A and B

Measure	Treatment A n = 138	Treatment B n = 138
Value	28600 (48.1)	27700 (41.5)

Treatment A vs Treatment B: Ratio of geometric least squares means: 1.020 (90% CI 0.977 to 1.065)

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 9. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 145 (0%)	8 of 145 (5.5%)	0 of 145
Treatment B	0 of 145 (0%)	10 of 145 (6.9%)	0 of 145
Treatment C	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sotorasib in people with Healthy Participants, run by Amgen at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05048784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.