Healthy SubjectsPhase 1NCT05578859
A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
A Phase 1 study testing AMG 510 in people with Healthy Subjects, run by Amgen at 1 site in United States.
Trial summary
The primary objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of [14C]-AMG 510, and to characterize the pharmacokinetic (PK) of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 24 Mar 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants between 18 and 55 years of age (inclusive) at the time of Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations as assessed by the Investigator (or designee).
- Body mass index between 18 and 30 kg/m2 (inclusive) at the time of Screening.
- History of a minimum of 1 bowel movement per day.
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 participant safety or interfere with the study evaluation, procedures, or completion.
- History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery other than uncomplicated appendectomy.
- Inability to swallow oral medication or history of malabsorption syndrome.
- 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.
- Poor peripheral venous access.
- History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
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- Participant has received a dose of an investigational drug (new chemical entity) within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in.
- Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
- Participants who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR)-recommended levels considered safe, per US Title 21 CFR 361.1: less than 5000 mrem whole body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc
Madison, Wisconsin, 53704
About this study
Official title: A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
The primary objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of [14C]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of [14C]-AMG 510 in healthy male participants.
- Conditions
- Healthy Subjects
- Being tested
- AMG 510
- Keywords
- Healthy volunteers, AMG 510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 510Drug
Single oral dose of AMG510.
| Study group | Role | What they receive |
|---|---|---|
| AMG510 | Experimental | Each participant will receive a single oral dose of AMG510 on Day 1 after an overnight fast. Receives: Drug: AMG 510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)
Measured: Day 1 to Day 14
AUC from time zero to the last quantifiable concentration (AUClast)
Measured: Day 1 to Day 14
Maximum observed concentration (Cmax)
Measured: Day 1 to Day 14
Time of Cmax (tmax)
Measured: Day 1 to Day 14
Apparent terminal elimination half-life (t1/2)
Measured: Day 1 to Day 14
Total clearance (AMG 510 only; CL/F)
Measured: Day 1 to Day 14
Volume of distribution (AMG 510 only; Vz/F)
Measured: Day 1 to Day 14
Plasma AMG 510 to total radioactivity ratio
Measured: Day 1 to Day 14
Whole blood to plasma total radioactivity ratio
Measured: Day 1 to Day 14
Amount (Aeu) of AMG510 excreted in urine
Measured: Day 1 to Day 14
Percentage (feu) of AMG510 excreted in urine
Measured: Day 1 to Day 14
Renal clearance (CLR) of AMG510
Measured: Day 1 to Day 14
Amount (Aef) of AMG510 excreted in feces
Measured: Day 1 to Day 14
Percentage (fef) of AMG510 excreted in feces
Measured: Day 1 to Day 14
Secondary outcomes (4)
Metabolite profile of AMG 510
Measured: Day 1 to Day 14
Identification of AMG 510 metabolites
Measured: Day 1 to Day 14
Incidence of adverse events
Adverse events will be graded by severity. Laboratory abnormalities (hematology, clinical chemistry, and urinalysis test results) will be recorded as adverse events, in addition to abnormalities in vital signs and physical examinations.
Measured: Up to approximately 6 weeks
QTc interval measured by 12-lead electrocardiogram (ECG)
Measured: Up to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start11 Mar 2020
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 8 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
- NCT05578859
- Sponsor's protocol ID
- 20190321
- Status last verified
- Nov 2022
- First submitted
- 11 Oct 2022
- Last updated
- 7 Nov 2022
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05578859
- Acronym / sponsor ID
- 20190321
- Conditions
- Healthy Subjects
- Keywords
- Healthy volunteers, AMG 510
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 13 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 objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of [14C]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of [14C]-AMG 510 in healthy male 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 |
|---|---|---|
| AMG510 | Experimental | Drug: AMG 510Each participant will receive a single oral dose of AMG510 on Day 1 after an overnight fast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male participants between 18 and 55 years of age (inclusive) at the time of Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations as assessed by the Investigator (or designee).
- Body mass index between 18 and 30 kg/m2 (inclusive) at the time of Screening.
- History of a minimum of 1 bowel movement per day.
Key exclusion criteria (9 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 participant safety or interfere with the study evaluation, procedures, or completion.
- History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery other than uncomplicated appendectomy.
- Inability to swallow oral medication or history of malabsorption syndrome.
- 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.
- Poor peripheral venous access.
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 510Single oral dose of AMG510. | Drug | AMG510 |
Primary outcome
Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)
Time frame: Day 1 to Day 14
AUC from time zero to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 14
Maximum observed concentration (Cmax)
Time frame: Day 1 to Day 14
Time of Cmax (tmax)
Time frame: Day 1 to Day 14
Apparent terminal elimination half-life (t1/2)
Time frame: Day 1 to Day 14
Total clearance (AMG 510 only; CL/F)
Time frame: Day 1 to Day 14
Volume of distribution (AMG 510 only; Vz/F)
Time frame: Day 1 to Day 14
Plasma AMG 510 to total radioactivity ratio
Time frame: Day 1 to Day 14
Whole blood to plasma total radioactivity ratio
Time frame: Day 1 to Day 14
Amount (Aeu) of AMG510 excreted in urine
Time frame: Day 1 to Day 14
Percentage (feu) of AMG510 excreted in urine
Time frame: Day 1 to Day 14
Renal clearance (CLR) of AMG510
Time frame: Day 1 to Day 14
Amount (Aef) of AMG510 excreted in feces
Time frame: Day 1 to Day 14
Percentage (fef) of AMG510 excreted in feces
Time frame: Day 1 to Day 14
4 secondary outcomes
Metabolite profile of AMG 510
Time frame: Day 1 to Day 14
Identification of AMG 510 metabolites
Time frame: Day 1 to Day 14
Incidence of adverse events
Time frame: Up to approximately 6 weeks
QTc interval measured by 12-lead electrocardiogram (ECG)
Time frame: Up to approximately 6 weeks
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 Nov 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 Subjects, 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 4 inclusion and 9 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 Nov 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?
Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf) (time frame: Day 1 to Day 14). The study lists 14 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 Nov 2022.