Healthy ParticipantsPhase 1NCT05571163
A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Participants
A Phase 1 study testing AMG 510 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 pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AMG 510
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to 14 Jun 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects or healthy female between 18 and 55 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
- 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.
- Inability to swallow oral medication or history of malabsorption syndrome.
- Poor peripheral venous access.
- History of significant 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc 1341 W Mockingbird Ln, Ste 200E
Dallas, Texas, 75247
About this study
Official title: An Open-label, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Subjects
The primary objective of the study is to evaluate the pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- AMG 510
- Keywords
- Healthy participants, AMG 510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 510Drug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Participants will be administered AMG 510 in the following order:
Period 1 (treatment A) - AMG 510 as oral tablets. Period 2 (treatment B) - AMG 510 as tablets dispersed in water. Receives: Drug: AMG 510 |
| Treatment Sequence BA | Experimental | Participants will be administered AMG 510 in the following order:
Period 1 (treatment B) - AMG 510 as tablets dispersed in water. Period 2 (treatment A) - AMG 510 as oral tablets. Receives: Drug: AMG 510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of AMG 510
Measured: Day 1 and Day 4
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510
Measured: Day 1 and Day 4
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510
Measured: Day 1 and Day 4
Secondary outcomes (1)
Number of Participants with an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs .
Measured: Day 1 to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start6 Mar 2020
- Primary completion14 Jun 2020
- Study completion14 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 13 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
- NCT05571163
- Sponsor's protocol ID
- 20190500
- Status last verified
- Sep 2022
- First submitted
- 5 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05571163
- Acronym / sponsor ID
- 20190500
- Conditions
- Healthy Participants
- Keywords
- Healthy participants, AMG 510
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 14 Jun 2020 (actual)
- Study completion
- 14 Jun 2020 (actual)
- First posted
- 7 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 pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: AMG 510Participants will be administered AMG 510 in the following order: Period 1 (treatment A) - AMG 510 as oral tablets. Period 2 (treatment B) - AMG 510 as tablets dispersed in water. |
| Treatment Sequence BA | Experimental | Drug: AMG 510Participants will be administered AMG 510 in the following order: Period 1 (treatment B) - AMG 510 as tablets dispersed in water. Period 2 (treatment A) - AMG 510 as oral tablets. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects or healthy female between 18 and 55 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)
- 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.
- Inability to swallow oral medication or history of malabsorption syndrome.
- Poor peripheral venous access.
- History of significant 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.
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 510Tablets | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of AMG 510
Time frame: Day 1 and Day 4
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510
Time frame: Day 1 and Day 4
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510
Time frame: Day 1 and Day 4
1 secondary outcome
Number of Participants with an Adverse Event (AE)
Time frame: Day 1 to Day 6
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 7 Oct 2022.
- 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 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 7 Oct 2022. 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 Observed Plasma Concentration (Cmax) of AMG 510 (time frame: Day 1 and Day 4). 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?
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 7 Oct 2022.