Healthy ParticipantsPhase 1NCT05598281
Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants
A Phase 1 study testing AMG 510 and Digoxin in people with Healthy Participants, run by Amgen at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants. 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?
- AMG 510 and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 19 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m2 (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 not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc
Daytona Beach, Florida, 32117
About this study
Official title: An Open-label, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects
The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- AMG 510, Digoxin
- Keywords
- AMG 510, Healthy Participants, Digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 510Drug
Also called Sotorasib
Oral tablet
DigoxinDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| AMG 510 + Digoxin | Experimental | Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7. Receives: Drug: AMG 510; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone
Measured: Day 1
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone
Measured: Day 1
AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone
Measured: Day 1
Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510
Measured: Day 7
AUClast of Digoxin Administered in Combination with AMG 510
Measured: Day 7
AUCinf of Digoxin Administered in Combination with AMG 510
Measured: Day 7
Secondary outcomes (4)
Number of Participants with an Adverse Event (AE)
Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.
Measured: Day 1 to Day 13
Cmax of AMG 510 Administered in Combination with Digoxin
Measured: Day 7
AUClast of AMG 510 Administered in Combination with Digoxin
Measured: Day 7
AUCinf of AMG 510 Administered in Combination with Digoxin
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start5 Nov 2019
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598281
- Sponsor's protocol ID
- 20190315
- Status last verified
- Apr 2025
- First submitted
- 25 Oct 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- 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, Houk B. Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P-Glycoprotein Substrate. Clin Pharmacol Drug Dev. 2025 Apr;14(4):298-303. doi: 10.1002/cpdd.1501. Epub 2025 Jan 7.
PubMed 39777405
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05598281
- Acronym / sponsor ID
- 20190315
- Conditions
- Healthy Participants
- Keywords
- AMG 510, Healthy Participants, Digoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMG 510 + Digoxin | Experimental | Drug: AMG 510, Drug: DigoxinParticipants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
- Body mass index, between 18 and 30 kg/m2 (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 not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject 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 |
|---|---|---|
| AMG 510Also: SotorasibOral tablet | Drug | AMG 510 + Digoxin |
| DigoxinOral tablet | Drug | AMG 510 + Digoxin |
Primary outcome
Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone
Time frame: Day 1
AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone
Time frame: Day 1
Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510
Time frame: Day 7
AUClast of Digoxin Administered in Combination with AMG 510
Time frame: Day 7
AUCinf of Digoxin Administered in Combination with AMG 510
Time frame: Day 7
4 secondary outcomes
Number of Participants with an Adverse Event (AE)
Time frame: Day 1 to Day 13
Cmax of AMG 510 Administered in Combination with Digoxin
Time frame: Day 7
AUClast of AMG 510 Administered in Combination with Digoxin
Time frame: Day 7
AUCinf of AMG 510 Administered in Combination with Digoxin
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 39777405Cardona P, Houk B. Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P-Glycoprotein Substrate. Clin Pharmacol Drug Dev. 2025 Apr;14(4):298-303. doi: 10.1002/cpdd.1501. Epub 2025 Jan 7.
- 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 AMG 510 and Digoxin in people with Healthy Participants, 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 2 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Plasma Concentration (Cmax) of Digoxin Administered Alone (time frame: Day 1). The study lists 6 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 NCT05598281, 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 2 Apr 2025.