Healthy VolunteersPhase 1NCT06362642
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants
A Phase 1 study testing PC14586 and Itraconazole in people with Healthy Volunteers, run by PMV Pharmaceuticals, Inc at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole 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 Volunteers
- What is being tested?
- PC14586 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 22 Oct 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, aged 18-55 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.
- Females of non-childbearing potential, males who agree to a highly effective method of contraception from first dose through 3 months after end of study visit.
- Participants who are able to swallow tablets and capsules.
- Participants who are capable and willing of giving signed informed consent.
Who cannot join
- Participants with significant medical history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
- History of significant hypersensitivity, intolerance, or allergy to itraconazole or any of the excipients or to medicinal products with similar chemical structures, food or other substance.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Participant has blood pressure >140 mmHg systolic or >90 mmHg diastolic at screening or Day -1.
- Prolonged QT interval corrected for heart rate using Fridericia's correction >450 ms for males and >470 ms for females at screening.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
Show all 14Show fewer
- Abnormalities in liver function test ALT or AST >1.5 × upper limit of normal.
- Administration of any vaccine including coronavirus disease 2019 vaccine in the past 14 days prior to check-in.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in.
- Use or intend to use any prescription medications/products or any nonprescription medications/products within 14 days prior to check-in.
- Participation in a clinical study involving last administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing, or within 5 half-lives of the IMP, whichever is longer, or have previously received PC14586.
- Participant has a history of alcohol or drug/chemical abuse within 2 years prior to check-in and/or is unwilling to avoid use of caffeine or alcohol or caffeine-containing foods or alcohol-containing foods, medications, or beverages, within 48 hours prior to check-in until the follow up visit.
- Use of tobacco- or nicotine-containing products (cigarettes, snuff, chewing tobacco, cigars, pipes, vaporizer, or nicotine-replacement products such as nicotine chewing gum and nicotine patches) within 3 months prior to check-in, or positive cotinine at screening or check-in.
- Participants with a germline TP53 Y220C mutation at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of Coadministration of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants
The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants.
Read the detailed description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.
This is a Phase 1, open-label, fixed-sequence study to investigate the effect of coadministration of itraconazole on the pharmacokinetics (PK) of PC14586 (rezatapopt) in healthy male and female participants. Potential participants will be screened to assess their eligibility to enter the study within 56 days prior to the first dose administration. Participants will be admitted into the study site on Day -1 and be confined to the study site until discharge on Day 33. Participants will return to the study site for PK sample collection on Day 37 and a follow-up visit and PK sample collection on Day 42.
Approximately 16 participants will be enrolled in this study.
- Conditions
- Healthy Volunteers
- Being tested
- PC14586, Itraconazole
- Keywords
- Y220C, PC14586, PMV Pharma, PMV, itraconazole, rezatapopt, Phase 1, CYP3A4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC14586Drug
Also called rezatapopt
First-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.
ItraconazoleDrug
Antifungal treatment that is a potent inhibitor of CYP3A4.
| Study group | Role | What they receive |
|---|---|---|
| PC14586 and Itraconazole | Experimental | Healthy participants will receive a single, oral dose of PC14586 on day 1. On day 20, participants will receive BID oral doses of itraconazole. On days 21-22, participants will receive a single, oral dose of itraconazole. On day 23, participants will receive a single, oral dose of PC14586 and a single oral dose of itraconazole. On days 24-27, participants will receive a single, oral dose of itraconazole. Receives: Drug: PC14586; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants.
Determine the Cmax of PC14586 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants.
Determine the AUC0-inf of PC14586 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants.
Determine the Tmax of PC14586 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants.
Determine the AUC0-24 of PC14586 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants.
Determine the AUC0-t of PC14586 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants.
Determine the t1/2 of PC14586 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Secondary outcomes (10)
Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Determine the Cmax of PC14586 metabolites M13 and M14 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Determine the AUC0-inf of PC14586 metabolites M13 and M14 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Determine the Tmax of PC14586 metabolites M13 and M14 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Determine the AUC0-24 of PC14586 metabolites M13 and M14 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Determine the AUC0-t of PC14586 metabolites M13 and M14 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Determine the t1/2 of PC14586 metabolites M13 and M14 when co-administered with itraconazole in plasma.
Measured: 6 weeks
Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants.
Identify the incidence of TEAEs of PC14586 alone or when co-administered with itraconazole.
Measured: 6 weeks
Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants.
Identify the number of participants with abnormal vital signs.
Measured: 6 weeks
Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants.
Identify the number of participants with abnormal ECG results.
Measured: 6 weeks
Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants.
Identify the number of participants with an incidence of laboratory abnormalities in test results.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start28 Mar 2024
- Primary completion22 Oct 2024
- Study completion22 Oct 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD.
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06362642
- Sponsor's protocol ID
- PMV-586-105
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2024
- 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, Fixed-sequence Study to Investigate the Effect of Coadministration of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06362642
- Acronym / sponsor ID
- PMV-586-105
- Conditions
- Healthy Volunteers
- Keywords
- Y220C, PC14586, PMV Pharma, PMV, itraconazole, rezatapopt, Phase 1, CYP3A4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PMV Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 12 Apr 2024 (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 purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants.
Detailed description
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation.
This is a Phase 1, open-label, fixed-sequence study to investigate the effect of coadministration of itraconazole on the pharmacokinetics (PK) of PC14586 (rezatapopt) in healthy male and female participants. Potential participants will be screened to assess their eligibility to enter the study within 56 days prior to the first dose administration. Participants will be admitted into the study site on Day -1 and be confined to the study site until discharge on Day 33. Participants will return to the study site for PK sample collection on Day 37 and a follow-up visit and PK sample collection on Day 42.
Approximately 16 participants will be enrolled in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD.
| Arm | Type | Receives |
|---|---|---|
| PC14586 and Itraconazole | Experimental | Drug: PC14586, Drug: ItraconazoleHealthy participants will receive a single, oral dose of PC14586 on day 1. On day 20, participants will receive BID oral doses of itraconazole. On days 21-22, participants will receive a single, oral dose of itraconazole. On day 23, participants will receive a single, oral dose of PC14586 and a single oral dose of itraconazole. On days 24-27, participants will receive a single, oral dose of itraconazole. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, non-smoking males and females, aged 18-55 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.
- Females of non-childbearing potential, males who agree to a highly effective method of contraception from first dose through 3 months after end of study visit.
- Participants who are able to swallow tablets and capsules.
- Participants who are capable and willing of giving signed informed consent.
Key exclusion criteria (14 listed)
- Participants with significant medical history or clinical manifestation of any medical condition, disease or disorder, as determined by the investigator.
- History of significant hypersensitivity, intolerance, or allergy to itraconazole or any of the excipients or to medicinal products with similar chemical structures, food or other substance.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
- Participant has blood pressure >140 mmHg systolic or >90 mmHg diastolic at screening or Day -1.
- Prolonged QT interval corrected for heart rate using Fridericia's correction >450 ms for males and >470 ms for females at screening.
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 |
|---|---|---|
| PC14586Also: rezatapoptFirst-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. | Drug | PC14586 and Itraconazole |
| ItraconazoleAntifungal treatment that is a potent inhibitor of CYP3A4. | Drug | PC14586 and Itraconazole |
Primary outcome
Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Determine the Cmax of PC14586 when co-administered with itraconazole in plasma.
Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Determine the AUC0-inf of PC14586 when co-administered with itraconazole in plasma.
Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Determine the Tmax of PC14586 when co-administered with itraconazole in plasma.
Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Determine the AUC0-24 of PC14586 when co-administered with itraconazole in plasma.
Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Determine the AUC0-t of PC14586 when co-administered with itraconazole in plasma.
Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Determine the t1/2 of PC14586 when co-administered with itraconazole in plasma.
10 secondary outcomes
Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants.
Time frame: 6 weeks
Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants.
Time frame: 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 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 and Itraconazole 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 5 inclusion and 14 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?
Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants. (time frame: 6 weeks). 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?
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.