Healthy Male VolunteersPhase 1NCT05523687
AME Study of [14C]-PC14586 in Healthy Male Participants
A Phase 1 study testing [14C]-PC14586 in people with Healthy Male Volunteers, run by PMV Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This study will assess the PK and rates of elimination and mass balance of total radioactivity from [14C]-PC14586 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 Male Volunteers
- What is being tested?
- [14C]-PC14586
- 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
- 6 Sep 2022to 30 Nov 2022
- 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, non-smoking males of any race, between 18 and 55 years of age, with BMI between 18.0 and 32.0 kg/m2 inclusive.
- In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the investigator.
- Agree to use a highly effective method of contraception from check-in through 90 days after discharge.
- History of a minimum of 1 bowel movement per day.
- Creatinine clearance ≥90 mL/min determined using the Cockcroft-Gault equation.
- Able to swallow capsules.
Who cannot join
- Significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
- Blood pressure >140 mm systolic or >90 diastolic at screening or Day -1.
- Positive hepatitis panel and/or positive human immunodeficiency virus test
- Use or intend to use any prescription and/or nonprescription medications/products within14 days prior to check-in.
- Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to dosing, or within 5 half-lives of the IMP, whichever is longer, or who have participated in more than 3 radiolabeled drug studies in the last 12 months.
- Participants who have previously completed or withdrawn from this study or any other study investigating PC14586, or have previously received PC14586.
- Participants with a history of alcoholism or drug/chemical abuse within 2 years prior to check-in, use of tobacco or nicotine-containing products within 3 months prior to check-in or with a positive drug and/or alcohol test result at check-in.
- A positive p53 Y220C germline test at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-PC14586 Following a Single Oral Dose in Healthy Male Participants
This study will assess the PK and rates of elimination and mass balance of total radioactivity from [14C]-PC14586
Read the detailed description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The study will assess the PK, absorption, metabolism, and excretion of [14C]-PC14586 following a single dose in healthy male participants.
The aim is to recruit approximately 8 participants with a minimum number of 6 evaluable participants.
Each participant will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 14. Participants will receive a single administration of [14C]-PC14586 as oral capsules on Day 1. During this study, whole blood, plasma, urine, feces, and vomit samples (if presented) will be collected at various timepoints to characterize the absorption, metabolism, excretion, and PK of [14C]-PC14586.
The duration of the residential period will be evaluated following the administration of [14C]-PC14586 and may be extended to ensure recovery of at least 90% of the total radioactivity, or until less than 1% of dose is recovered in urine and/or feces.
- Conditions
- Healthy Male Volunteers
- Being tested
- [14C]-PC14586
- Keywords
- Y220C, PC14586, PMV Pharma, PMV, AME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-PC14586Drug
Single, oral dose of [14C]-PC14586
| Study group | Role | What they receive |
|---|---|---|
| Single, oral dose of [14C]-PC14586 | Experimental | Healthy, male participants will receive a single, oral dose of [14C]-PC14586 Receives: Drug: [14C]-PC14586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163).
Determine Cmax for PC14586 and PC16163 in plasma.
Measured: 1 month
Characterize Time to Maximum Plasma Concentration (tmax) of PC14586 and PC14586 metabolite M1 (PC16163).
Determine tmax for PC14586 and PC16163 in plasma.
Measured: 1 month
Characterize Total Drug Exposure (AUC0-inf) of PC14586 and PC14586 metabolite M1 (PC16163).
Determine AUC0-inf for PC14586 and PC16163 in plasma.
Measured: 1 month
Characterize Total Drug Exposure to the last measurable concentration (AUC0-t) of PC14586 and PC14586 metabolite M1 (PC16163).
Determine AUC0-t for PC14586 and PC16163 in plasma.
Measured: 1 month
Characterize the Half-Life (t 1/2) of PC14586 and PC14586 metabolite M1 (PC16163).
Determine t 1/2 for PC14586 and PC16163 in plasma.
Measured: 1 month
Characterize the Clearance (CL/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
Determine CL/F for PC14586 and PC16163 in plasma.
Measured: 1 month
Characterize the Volume of Distribution (Vd/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
Determine Vd/F for PC14586 and PC16163 in plasma.
Measured: 1 month
Determine the total radioactivity in whole blood and plasma of PC14586 and PC14586 metabolite M1 (PC16163).
Determine total radioactivity for PC14586 and PC16163 in whole blood and plasma.
Measured: 1 month
Characterize total radioactivity (Xlast, feces) of PC14586 excreted in feces.
Determine total radioactivity of PC14586 excreted in feces
Measured: 1 month
Characterize the half life of total radioactivity (Xt1-t2, feces) of PC14586 excreted in feces.
Determine half life of total radioactivity of PC14586 excreted in feces.
Measured: 1 month
Characterize the fraction excreted of total radioactivity (fe last, feces) of PC14586 in feces.
Determine the fraction excreted of total radioactivity of PC14586 in feces.
Measured: 1 month
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, feces) of PC14586 in feces.
Determine half-life of fraction excreted of total radioactivity of PC14586 in feces.
Measured: 1 month
Characterize total radioactivity (Xlast, urine) of PC14586 excreted in urine.
Determine total radioactivity of PC14586 excreted in urine.
Measured: 1 month
Characterize the half life of total radioactivity (Xt1-t2, urine) of PC14586 excreted in urine.
Determine half life of total radioactivity of PC14586 excreted in urine.
Measured: 1 month
Characterize the fraction excreted of total radioactivity (fe last, urine) of PC14586 in urine.
Determine the fraction excreted of total radioactivity of PC14586 in urine.
Measured: 1 month
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, urine) of PC14586 in urine.
Determine half-life of fraction excreted of total radioactivity of PC14586 in urine.
Measured: 1 month
Characterize the renal clearance (CLr) of PC14586 in urine.
Determine the renal clearance of PC14586 in urine.
Measured: 1 month
Secondary outcomes (7)
Identification of PC14586 metabolite profiles in plasma, urine and feces.
Identification of PC14586 metabolites in plasma (>10% relative total drug related exposure) and excreta (>10% of excreted dose).
Measured: 1 month
Identification of the incidence and severity of adverse events after administration of PC14586.
Number of participants with adverse events.
Measured: 1 month
Identification of the incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results of PC14586.
Number of participants with an incidence of laboratory abnormalities in test results.
Measured: 1 month
Identification of 12-lead electrocardiogram (ECG) abnormalities after a single dose of PC14586.
Number of participants with abnormal 12-lead ECG results.
Measured: 1 month
Identification of abnormal blood pressure after a single dose of PC14586.
Number of participants with abnormal blood pressure.
Measured: 1 month
Identification of abnormal pulse rate after a single dose of PC14586.
Number of participants with abnormal pulse rate.
Measured: 1 month
Identification of abnormal oral body temperature after a single dose of PC14586.
Number of participants with abnormal oral body temperature.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start6 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMV Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523687
- Sponsor's protocol ID
- PMV-586-103
- Status last verified
- Dec 2022
- First submitted
- 22 Aug 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-PC14586 Following a Single Oral Dose in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05523687
- Acronym / sponsor ID
- PMV-586-103
- Conditions
- Healthy Male Volunteers
- Keywords
- Y220C, PC14586, PMV Pharma, PMV, AME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PMV Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 31 Aug 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.
This study will assess the PK and rates of elimination and mass balance of total radioactivity from [14C]-PC14586
Detailed description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The study will assess the PK, absorption, metabolism, and excretion of [14C]-PC14586 following a single dose in healthy male participants.
The aim is to recruit approximately 8 participants with a minimum number of 6 evaluable participants.
Each participant will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 14. Participants will receive a single administration of [14C]-PC14586 as oral capsules on Day 1. During this study, whole blood, plasma, urine, feces, and vomit samples (if presented) will be collected at various timepoints to characterize the absorption, metabolism, excretion, and PK of [14C]-PC14586.
The duration of the residential period will be evaluated following the administration of [14C]-PC14586 and may be extended to ensure recovery of at least 90% of the total radioactivity, or until less than 1% of dose is recovered in urine and/or feces.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single, oral dose of [14C]-PC14586 | Experimental | Drug: [14C]-PC14586Healthy, male participants will receive a single, oral dose of [14C]-PC14586 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, non-smoking males of any race, between 18 and 55 years of age, with BMI between 18.0 and 32.0 kg/m2 inclusive.
- In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the investigator.
- Agree to use a highly effective method of contraception from check-in through 90 days after discharge.
- History of a minimum of 1 bowel movement per day.
- Creatinine clearance ≥90 mL/min determined using the Cockcroft-Gault equation.
Key exclusion criteria (8 listed)
- Significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
- Blood pressure >140 mm systolic or >90 diastolic at screening or Day -1.
- Positive hepatitis panel and/or positive human immunodeficiency virus test
- Use or intend to use any prescription and/or nonprescription medications/products within14 days prior to check-in.
- Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to dosing, or within 5 half-lives of the IMP, whichever is longer, or who have participated in more than 3 radiolabeled drug studies in the last 12 months.
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 |
|---|---|---|
| [14C]-PC14586Single, oral dose of [14C]-PC14586 | Drug | Single, oral dose of [14C]-PC14586 |
Primary outcome
Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163).
Time frame: 1 month
Determine Cmax for PC14586 and PC16163 in plasma.
Characterize Time to Maximum Plasma Concentration (tmax) of PC14586 and PC14586 metabolite M1 (PC16163).
Time frame: 1 month
Determine tmax for PC14586 and PC16163 in plasma.
Characterize Total Drug Exposure (AUC0-inf) of PC14586 and PC14586 metabolite M1 (PC16163).
Time frame: 1 month
Determine AUC0-inf for PC14586 and PC16163 in plasma.
Characterize Total Drug Exposure to the last measurable concentration (AUC0-t) of PC14586 and PC14586 metabolite M1 (PC16163).
Time frame: 1 month
Determine AUC0-t for PC14586 and PC16163 in plasma.
Characterize the Half-Life (t 1/2) of PC14586 and PC14586 metabolite M1 (PC16163).
Time frame: 1 month
Determine t 1/2 for PC14586 and PC16163 in plasma.
Characterize the Clearance (CL/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
Time frame: 1 month
Determine CL/F for PC14586 and PC16163 in plasma.
Characterize the Volume of Distribution (Vd/F) of PC14586 and PC14586 metabolite M1 (PC16163) after oral administration.
Time frame: 1 month
Determine Vd/F for PC14586 and PC16163 in plasma.
Determine the total radioactivity in whole blood and plasma of PC14586 and PC14586 metabolite M1 (PC16163).
Time frame: 1 month
Determine total radioactivity for PC14586 and PC16163 in whole blood and plasma.
Characterize total radioactivity (Xlast, feces) of PC14586 excreted in feces.
Time frame: 1 month
Determine total radioactivity of PC14586 excreted in feces
Characterize the half life of total radioactivity (Xt1-t2, feces) of PC14586 excreted in feces.
Time frame: 1 month
Determine half life of total radioactivity of PC14586 excreted in feces.
Characterize the fraction excreted of total radioactivity (fe last, feces) of PC14586 in feces.
Time frame: 1 month
Determine the fraction excreted of total radioactivity of PC14586 in feces.
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, feces) of PC14586 in feces.
Time frame: 1 month
Determine half-life of fraction excreted of total radioactivity of PC14586 in feces.
Characterize total radioactivity (Xlast, urine) of PC14586 excreted in urine.
Time frame: 1 month
Determine total radioactivity of PC14586 excreted in urine.
Characterize the half life of total radioactivity (Xt1-t2, urine) of PC14586 excreted in urine.
Time frame: 1 month
Determine half life of total radioactivity of PC14586 excreted in urine.
Characterize the fraction excreted of total radioactivity (fe last, urine) of PC14586 in urine.
Time frame: 1 month
Determine the fraction excreted of total radioactivity of PC14586 in urine.
Characterize the half-life of fraction excreted of total radioactivity (fe t1-t2, urine) of PC14586 in urine.
Time frame: 1 month
Determine half-life of fraction excreted of total radioactivity of PC14586 in urine.
Characterize the renal clearance (CLr) of PC14586 in urine.
Time frame: 1 month
Determine the renal clearance of PC14586 in urine.
7 secondary outcomes
Identification of PC14586 metabolite profiles in plasma, urine and feces.
Time frame: 1 month
Identification of the incidence and severity of adverse events after administration of PC14586.
Time frame: 1 month
Identification of the incidence of laboratory abnormalities based on hematology, clinical chemistry and urine test results of PC14586.
Time frame: 1 month
Identification of 12-lead electrocardiogram (ECG) abnormalities after a single dose of PC14586.
Time frame: 1 month
Identification of abnormal blood pressure after a single dose of PC14586.
Time frame: 1 month
Identification of abnormal pulse rate after a single dose of PC14586.
Time frame: 1 month
Identification of abnormal oral body temperature after a single dose of PC14586.
Time frame: 1 month
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 20 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]-PC14586 in people with Healthy Male Volunteers, run by PMV Pharmaceuticals, Inc 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 6 inclusion and 8 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 20 Dec 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?
Characterize Maximum Plasma Concentration (Cmax) of PC14586 and PC14586 metabolite M1 (PC16163). (time frame: 1 month). The study lists 17 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 20 Dec 2022.