Healthy VolunteersPhase 1NCT05497557

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

A Phase 1 study testing Omeprazole and Sotorasib in people with Healthy Volunteers, run by Amgen at 1 site in United States.

Completed

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

Official record

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Trial summary

The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Omeprazole and Sotorasib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2022to 8 Sep 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

1 site in 1 country.

United States1 site

Labcorp Clinical Research Unit Inc.
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: An Open-label Study to Evaluate the Impact of Omeprazole, A Proton Pump Inhibitor, on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

Conditions: Healthy Volunteers
Being tested: Omeprazole, Sotorasib
Keywords: Healthy volunteers, Sotorasib, AMG 510, Omeprazole

What participants receive

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

OmeprazoleDrug
Omeprazole will be administered as an oral capsule.
SotorasibDrug
Also called AMG 510
Sotorasib will be administered as an oral tablet.

Study groups in NCT05497557
Study group	Role	What they receive
Omeprazole + Sotorasib	Experimental	Not described Receives: Drug: Omeprazole; 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
Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib
Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib
Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9

Secondary outcomes (1)

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
An adverse event is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. A TEAE was defined as an adverse event that starts during or after the first dose, or starts prior to the first dose and increases in severity after the first dose. Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs were recorded as an adverse event.
Measured: Day 1 to Day 11

Timeline

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

14 Jul 20228 Sep 2022

First posted11 Aug 2022
Study start14 Jul 2022
Primary completion8 Sep 2022
Study completion8 Sep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05497557
Sponsor's protocol ID: 20220024
Status last verified: Apr 2023
First submitted: 3 Aug 2022
Last updated: 19 Jan 2024
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.

Publications

Cardona P, Strydom N, Houk B. Impact of Acid-Reducing Agents on Sotorasib Pharmacokinetics and Potential Mitigation of the Impact by Coadministration With an Acidic Beverage. Clin Pharmacol Drug Dev. 2025 Feb;14(2):167-176. doi: 10.1002/cpdd.1489. Epub 2024 Nov 27.
PubMed 39604046

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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Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Impact of Omeprazole, A Proton Pump Inhibitor, on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
ClinicalTrials.gov ID: NCT05497557
Acronym / sponsor ID: 20220024
Conditions: Healthy Volunteers
Keywords: Healthy volunteers, Sotorasib, AMG 510, Omeprazole
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 14 Jul 2022 (actual)
Primary completion: 8 Sep 2022 (actual)
Study completion: 8 Sep 2022 (actual)
First posted: 11 Aug 2022 (actual)
Results: Posted 19 Jan 2024

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Omeprazole + Sotorasib	Experimental	Drug: Omeprazole, Drug: Sotorasib

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
OmeprazoleOmeprazole will be administered as an oral capsule.	Drug	Omeprazole + Sotorasib
SotorasibAlso: AMG 510Sotorasib will be administered as an oral tablet.	Drug	Omeprazole + Sotorasib

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Sotorasib
Time frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib
Time frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib
Time frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9

1 secondary outcome

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 to Day 11

Results and safety

Results posted to the registry on 19 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sotorasib Alone	16	16
Omeprazole Alone	0	0
Omeprazole Co-administered With Sotorasib	0	0

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Sotorasib

Time frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Sotorasib Alone n = 16	Omeprazole Co-administered With Sotorasib n = 14
Value	7160 (22.9)	4850 (65.6)

Sotorasib Alone vs Omeprazole Co-administered With Sotorasib: Ratio of geometric least squares mean: 0.677 (90% CI 0.547 to 0.839)

Population analysed: Measured in the Pharmacokinetic Population for the primary endpoint analyses, which included all participants who received both sotorasib, and sotorasib in combination with omeprazole and an acidic beverage, and had evaluable pharmacokinetic data.

Primary outcome: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib

Measure	Sotorasib Alone n = 16	Omeprazole Co-administered With Sotorasib n = 14
Value	30200 (33.3)	23500 (60.4)

Sotorasib Alone vs Omeprazole Co-administered With Sotorasib: Ratio of geometric least squares mean: 0.771 (90% CI 0.628 to 0.948)

Primary outcome: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib

Measure	Sotorasib Alone n = 16	Omeprazole Co-administered With Sotorasib n = 14
Value	30000 (33.3)	23200 (62.2)

Sotorasib Alone vs Omeprazole Co-administered With Sotorasib: Ratio of geometric least squares mean: 0.766 (90% CI 0.619 to 0.948)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 to Day 11. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sotorasib Alone	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Omeprazole Alone	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
Omeprazole Co-administered With Sotorasib	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39604046Cardona P, Strydom N, Houk B. Impact of Acid-Reducing Agents on Sotorasib Pharmacokinetics and Potential Mitigation of the Impact by Coadministration With an Acidic Beverage. Clin Pharmacol Drug Dev. 2025 Feb;14(2):167-176. doi: 10.1002/cpdd.1489. Epub 2024 Nov 27.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Omeprazole and Sotorasib in people with Healthy Volunteers, run by Amgen at 1 site 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 19 Jan 2024). 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 (time frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9). 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 NCT05497557, which also lists 1 linked publication.

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 19 Jan 2024.