Healthy VolunteersPhase 1NCT06054464
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants
A Phase 1 study testing PC14586, Rabeprazole and Famotidine in people with Healthy Volunteers, run by PMV Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This study will assess the effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PC14586, Rabeprazole and Famotidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 6 Feb 2024
- 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, non-smoking males and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.
- Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.
- Participants who are capable of giving signed informed consent.
Who cannot join
- Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.
- Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.
- Participant has blood pressure > 140 mm systolic or > 90 mm diastolic at Screening or Day - 1.
- Participants with a germline TP53 Y220C mutation at Screening.
Show all 11Show fewer
- Participant has smoked or used other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, vaporizer, or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) during the 3 months before the Screening Visit.
- Participant has history of alcohol and/or illicit drug abuse within 5 years of Screening.
- Participant is unwilling to avoid use of alcohol or alcohol-containing foods, medications, or beverages, 48 hours prior to admission until discharge from the study center.
- Participant has a history of hypersensitivity to the study drug (PC14586), rabeprazole (Part 1), or famotidine (Part 2) or any of the excipients or to medicinal products with similar chemical structures.
- Female participant that is breastfeeding (or bottle feeding with their breast milk) or female participant with a positive serum pregnancy test at the Screening Visit or positive serum or urine pregnancy test at Day -1 (admission).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Non-Randomized, Two-Part, Fixed-Sequence, Study to Evaluate the Effects of Acid Reducing Agents on the Pharmacokinetics of PC14586 in Healthy Volunteers
This study will assess the effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586
Read the detailed description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. This study will investigate the effects of acid reducing agents on the pharmacokinetics of PC14586.
This is a 2-part, open-label, two-period, fixed-sequence study in healthy participants with each participant used as his/her own control to assess the effect of rabeprazole (Part 1) or famotidine (Part 2) on the PK of PC14586. The results from Part 1 will be analyzed before deciding to, if applicable, progress to Part 2. Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive.
Approximately 25 participants will be enrolled in Part 1 and approximately 25 participants will be enrolled in Part 2. The Study timelines reflect both Part 1 and Part 2.
- Conditions
- Healthy Volunteers
- Being tested
- PC14586, Rabeprazole, Famotidine
- Keywords
- Y220C, PC14586, PMV Pharma, PMV, Acid Reducing Agent, p53, DDI, Phase 1, p53 mutation, TP53 mutation, TP53, p53 mutant, p53 reactivator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC14586Drug
Part 1 and Part 2: Single, oral dose of PC14586 on day 1 and single, oral dose of PC14586 on day 14.
RabeprazoleDrug
Part 1: Daily oral dose of rabeprazole on days 11-14.
FamotidineDrug
Part 2: Twice daily oral dose of famotidine on days 11-13. Single, oral dose of famotidine on day 14.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: PC14586 and rabeprazole | Experimental | Healthy participants will receive a single, oral dose of PC14586 on day 1. On days 11-13, participants will receive an oral daily dose of rabeprazole. On day 14, participants will receive a co-administration dose of rabeprazole and PC14586. Rabeprazole will be given 1 hour prior to PC14586. Participants will be given a low-fat meal 30 minutes prior to PC14586 dosing. Receives: Drug: PC14586; Drug: Rabeprazole |
| Part 2: PC14586 and famotidine | Experimental | Healthy participants will receive a single, oral dose of PC14586 on day 1. On days 11-13, participants will receive a twice daily, oral dose of famotidine. On day 14, participants will receive PC14586 two hours before a dose of famotidine. Participants will be given a low-fat meal 30 minutes prior to PC14586 dosing. Receives: Drug: PC14586; Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole.
Determine the Cmax of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with rabeprazole.
Determine the AUC0-last of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with rabeprazole.
Determine the AUC0-inf of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with rabeprazole.
Determine the Tmax of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 2: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with famotidine.
Determine the Cmax of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with famotidine.
Determine the AUC0-last of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with famotidine.
Determine the AUC0-inf of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with famotidine.
Determine the Tmax of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Secondary outcomes (22)
Part 1: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) for PC14586 when co-administered with rabeprazole.
Determine the AUC0-24 of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the total drug exposure from time zero to 96 hours (AUC0-96) for PC14586 when co-administered rabeprazole.
Determine the AUC0-96 of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the percent AUCinf due to extrapolation beyond tlast (AUC%extrap) for PC14586 when co-administered with rabeprazole.
Determine the AUC%extrap of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the half-life (t1/2) for PC14586 when co-administered with rabeprazole.
Determine the t1/2 of PC14586 when co-administered with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the clearance (CL/F) for PC14586 when co-administered orally with rabeprazole.
Determine the CL/F of PC14586 when co-administered orally with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the volume of distribution (Vz/F) for PC14586 when co-administered orally with rabeprazole.
Determine the Vz/F of PC14586 when co-administered orally with rabeprazole in plasma.
Measured: 20 days
Part 1: Characterize the apparent terminal elimination rate (lambda Z) for PC14586 when co-administered orally with rabeprazole.
Determine the lambda Z of PC14586 when co-administered orally with rabeprazole in plasma.
Measured: 20 days
Part 1: Identification of the Incidence of treatment emergent adverse events (TEAE) for PC14586 alone or when co-administered with rabeprazole.
Identify the incidence of TEAEs of PC14586 alone or when co-administered orally with rabeprazole in plasma.
Measured: 20 days
Part 1: Identification of vital sign abnormalities after administration of PC14586 alone or when co-administered with rabeprazole.
Number of participants with abnormal vital signs.
Measured: 20 days
Part 1: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone or when co-administered with rabeprazole.
Number of participants with abnormal ECG results.
Measured: 20 days
Part 1: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone or when co-administered with rabeprazole.
Number of participants with an incidence of laboratory abnormalities in test results.
Measured: 20 days
Part 2: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) for PC14586 when co-administered with famotidine.
Determine the AUC0-24 of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the total drug exposure from time zero to 96 hours (AUC0-96) for PC14586 when co-administered with famotidine.
Determine the AUC0-96 of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the percent AUCinf due to extrapolation beyond tlast (AUC%extrap) for PC14586 when co-administered with famotidine.
Determine the AUC%extrap of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the half-life (t1/2) for PC14586 when co-administered with famotidine.
Determine the t1/2 of PC14586 when co-administered with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the clearance (CL/F) for PC14586 when co-administered orally with famotidine.
Determine the CL/F of PC14586 when co-administered orally with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the volume of distribution (Vz/F) for PC14586 when co-administered orally with famotidine.
Determine the Vz/F of PC14586 when co-administered orally with famotidine in plasma.
Measured: 20 days
Part 2: Characterize the apparent terminal elimination rate (lambda Z) for PC14586 when co-administered orally with famotidine.
Determine the lambda Z of PC14586 when co-administered orally with famotidine in plasma.
Measured: 20 days
Part 2: Identification of the Incidence of treatment emergent adverse events (TEAE) for PC14586 alone or when co-administered with famotidine.
Identify the incidence of TEAEs of PC14586 alone or when co-administered orally with famotidine in plasma.
Measured: 20 days
Part 2: Identification of vital sign abnormalities after administration of PC14586 alone or when co-administered with famotidine.
Number of participants with abnormal vital signs.
Measured: 20 days
Part 2: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone or when co-administered with famotidine.
Number of participants with abnormal ECG results.
Measured: 20 days
Part 2: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone or when co-administered with famotidine.
Number of participants with an incidence of laboratory abnormalities in test results.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start19 Sep 2023
- Primary completion3 Nov 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The treatment duration will be up to: 1 day for Treatment Period 1 (PC14586) and 4 days for Treatment Period 2 (PC14586 + ARA) for Parts 1 and 2.
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT06054464
- Sponsor's protocol ID
- PMV-586-104
- Status last verified
- Nov 2024
- First submitted
- 8 Sep 2023
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Non-Randomized, Two-Part, Fixed-Sequence, Study to Evaluate the Effects of Acid Reducing Agents on the Pharmacokinetics of PC14586 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06054464
- Acronym / sponsor ID
- PMV-586-104
- Conditions
- Healthy Volunteers
- Keywords
- Y220C, PC14586, PMV Pharma, PMV, Acid Reducing Agent, p53, DDI, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PMV Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 26 Sep 2023 (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 effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586
Detailed description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. This study will investigate the effects of acid reducing agents on the pharmacokinetics of PC14586.
This is a 2-part, open-label, two-period, fixed-sequence study in healthy participants with each participant used as his/her own control to assess the effect of rabeprazole (Part 1) or famotidine (Part 2) on the PK of PC14586. The results from Part 1 will be analyzed before deciding to, if applicable, progress to Part 2. Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive.
Approximately 25 participants will be enrolled in Part 1 and approximately 25 participants will be enrolled in Part 2. The Study timelines reflect both Part 1 and Part 2.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment duration will be up to: 1 day for Treatment Period 1 (PC14586) and 4 days for Treatment Period 2 (PC14586 + ARA) for Parts 1 and 2.
| Arm | Type | Receives |
|---|---|---|
| Part 1: PC14586 and rabeprazole | Experimental | Drug: PC14586, Drug: RabeprazoleHealthy participants will receive a single, oral dose of PC14586 on day 1. On days 11-13, participants will receive an oral daily dose of rabeprazole. On day 14, participants will receive a co-administration dose of rabeprazole and PC14586. Rabeprazole will be given 1 hour prior to PC14586. Participants will be given a low-fat meal 30 minutes prior to PC14586 dosing. |
| Part 2: PC14586 and famotidine | Experimental | Drug: PC14586, Drug: FamotidineHealthy participants will receive a single, oral dose of PC14586 on day 1. On days 11-13, participants will receive a twice daily, oral dose of famotidine. On day 14, participants will receive PC14586 two hours before a dose of famotidine. Participants will be given a low-fat meal 30 minutes prior to PC14586 dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, non-smoking males and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.
- Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.
- Participants who are capable of giving signed informed consent.
Key exclusion criteria (11 listed)
- Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.
- Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.
- Participant has blood pressure > 140 mm systolic or > 90 mm diastolic at Screening or Day - 1.
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 |
|---|---|---|
| PC14586Part 1 and Part 2: Single, oral dose of PC14586 on day 1 and single, oral dose of PC14586 on day 14. | Drug | Part 1: PC14586 and rabeprazole, Part 2: PC14586 and famotidine |
| RabeprazolePart 1: Daily oral dose of rabeprazole on days 11-14. | Drug | Part 1: PC14586 and rabeprazole |
| FamotidinePart 2: Twice daily oral dose of famotidine on days 11-13. Single, oral dose of famotidine on day 14. | Drug | Part 2: PC14586 and famotidine |
Primary outcome
Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Determine the Cmax of PC14586 when co-administered with rabeprazole in plasma.
Part 1: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Determine the AUC0-last of PC14586 when co-administered with rabeprazole in plasma.
Part 1: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Determine the AUC0-inf of PC14586 when co-administered with rabeprazole in plasma.
Part 1: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Determine the Tmax of PC14586 when co-administered with rabeprazole in plasma.
Part 2: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with famotidine.
Time frame: 20 days
Determine the Cmax of PC14586 when co-administered with famotidine in plasma.
Part 2: Characterize the total drug exposure to the last measurable concentration (AUC0-last) of PC14586 when co-administered with famotidine.
Time frame: 20 days
Determine the AUC0-last of PC14586 when co-administered with famotidine in plasma.
Part 2: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with famotidine.
Time frame: 20 days
Determine the AUC0-inf of PC14586 when co-administered with famotidine in plasma.
Part 2: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with famotidine.
Time frame: 20 days
Determine the Tmax of PC14586 when co-administered with famotidine in plasma.
22 secondary outcomes
Part 1: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) for PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Part 1: Characterize the total drug exposure from time zero to 96 hours (AUC0-96) for PC14586 when co-administered rabeprazole.
Time frame: 20 days
Part 1: Characterize the percent AUCinf due to extrapolation beyond tlast (AUC%extrap) for PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Part 1: Characterize the half-life (t1/2) for PC14586 when co-administered with rabeprazole.
Time frame: 20 days
Part 1: Characterize the clearance (CL/F) for PC14586 when co-administered orally with rabeprazole.
Time frame: 20 days
Part 1: Characterize the volume of distribution (Vz/F) for PC14586 when co-administered orally with rabeprazole.
Time frame: 20 days
Part 1: Characterize the apparent terminal elimination rate (lambda Z) for PC14586 when co-administered orally with rabeprazole.
Time frame: 20 days
Part 1: Identification of the Incidence of treatment emergent adverse events (TEAE) for PC14586 alone or when co-administered with rabeprazole.
Time frame: 20 days
Part 1: Identification of vital sign abnormalities after administration of PC14586 alone or when co-administered with rabeprazole.
Time frame: 20 days
Part 1: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone or when co-administered with rabeprazole.
Time frame: 20 days
Part 1: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone or when co-administered with rabeprazole.
Time frame: 20 days
Part 2: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) for PC14586 when co-administered with famotidine.
Time frame: 20 days
Part 2: Characterize the total drug exposure from time zero to 96 hours (AUC0-96) for PC14586 when co-administered with famotidine.
Time frame: 20 days
Part 2: Characterize the percent AUCinf due to extrapolation beyond tlast (AUC%extrap) for PC14586 when co-administered with famotidine.
Time frame: 20 days
Part 2: Characterize the half-life (t1/2) for PC14586 when co-administered with famotidine.
Time frame: 20 days
Part 2: Characterize the clearance (CL/F) for PC14586 when co-administered orally with famotidine.
Time frame: 20 days
Part 2: Characterize the volume of distribution (Vz/F) for PC14586 when co-administered orally with famotidine.
Time frame: 20 days
Part 2: Characterize the apparent terminal elimination rate (lambda Z) for PC14586 when co-administered orally with famotidine.
Time frame: 20 days
Part 2: Identification of the Incidence of treatment emergent adverse events (TEAE) for PC14586 alone or when co-administered with famotidine.
Time frame: 20 days
Part 2: Identification of vital sign abnormalities after administration of PC14586 alone or when co-administered with famotidine.
Time frame: 20 days
Part 2: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone or when co-administered with famotidine.
Time frame: 20 days
Part 2: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone or when co-administered with famotidine.
Time frame: 20 days
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 13 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 PC14586, Rabeprazole and Famotidine in people with Healthy 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 3 inclusion and 11 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 13 Nov 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?
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?
Part 1: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with rabeprazole. (time frame: 20 days). The study lists 8 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 13 Nov 2024.