Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PC14586 · 4 trials · 2 indications
Determine the Cmax of PC14586 when co-administered with itraconazole in plasma.
Determine the AUC0-inf of PC14586 when co-administered with itraconazole in plasma.
Determine the Tmax of PC14586 when co-administered with itraconazole in plasma.
Determine the AUC0-24 of PC14586 when co-administered with itraconazole in plasma.
Determine the AUC0-t of PC14586 when co-administered with itraconazole in plasma.
Determine the t1/2 of PC14586 when co-administered with itraconazole in plasma.
Determine the Cmax of PC14586 when co-administered with rabeprazole in plasma.
Determine the AUC0-last of PC14586 when co-administered with rabeprazole in plasma.
Determine the AUC0-inf of PC14586 when co-administered with rabeprazole in plasma.
Determine the Tmax of PC14586 when co-administered with rabeprazole in plasma.
Determine the Cmax of PC14586 when co-administered with famotidine in plasma.
Determine the AUC0-last of PC14586 when co-administered with famotidine in plasma.
Determine the AUC0-inf of PC14586 when co-administered with famotidine in plasma.
Determine the Tmax of PC14586 when co-administered with famotidine in plasma.
Determine Cmax for PC14586 and PC16163 in plasma.
Determine tmax for PC14586 and PC16163 in plasma.
Determine AUC0-inf for PC14586 and PC16163 in plasma.
Determine AUC0-t for PC14586 and PC16163 in plasma.
Determine t 1/2 for PC14586 and PC16163 in plasma.
Determine CL/F for PC14586 and PC16163 in plasma.
Determine Vd/F for PC14586 and PC16163 in plasma.
Determine total radioactivity for PC14586 and PC16163 in whole blood and plasma.
Determine total radioactivity of PC14586 excreted in feces
Determine half life of total radioactivity of PC14586 excreted in feces.
Determine the fraction excreted of total radioactivity of PC14586 in feces.
Determine half-life of fraction excreted of total radioactivity of PC14586 in feces.
Determine total radioactivity of PC14586 excreted in urine.
Determine half life of total radioactivity of PC14586 excreted in urine.
Determine the fraction excreted of total radioactivity of PC14586 in urine.
Determine half-life of fraction excreted of total radioactivity of PC14586 in urine.
Determine the renal clearance of PC14586 in urine.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Single, oral dose of [14C]-PC14586 | EXPERIMENTAL | Healthy, male participants will receive a single, oral dose of \[14C\]-PC14586 |
| Part 1 Sequence A | EXPERIMENTAL | Period 1 will be fed, then washout, then Period 2 will be fasted. |
| Part 1 Sequence B | EXPERIMENTAL | Period 1 will be fasted, then washout, then Period 2 will be fed. |
| Part 2 Sequence C | EXPERIMENTAL | Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested. |
| Part 2 Sequence D | EXPERIMENTAL | Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested. |
| Part 2 Japanese Cohort | EXPERIMENTAL | 6 Japanese participants will be administered a single dose of PC14586. |
| Name | Type | Description |
|---|---|---|
| PC14586 | DRUG | First-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. |
| Itraconazole | DRUG | Antifungal treatment that is a potent inhibitor of CYP3A4. |
| Rabeprazole | DRUG | Part 1: Daily oral dose of rabeprazole on days 11-14. |
| Famotidine | DRUG | Part 2: Twice daily oral dose of famotidine on days 11-13. Single, oral dose of famotidine on day 14. |
| [14C]-PC14586 | DRUG | Single, oral dose of \[14C\]-PC14586 |
Inclusion Criteria: 1. Healthy, non-smoking males and females, aged 18-55 years of age, with BMI between 18.0 and 32.0 kg/m2 inclusive. 2. In good health, determined by no clinically significant findings from medical history and evaluations at screening and check-in as assessed by the investigator....
PC14586 is an investigational small molecule being studied in healthy volunteers and healthy male volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics and effects in these populations. PC14586 is not approved for any indication and remains under investigation.
PC14586 is being developed by PMV Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PMVP. The company is conducting Phase 1 clinical trials of PC14586 in healthy volunteers to assess its safety and pharmacokinetic profile.
PC14586 is in Phase 1 clinical development. All three completed trials involving PC14586 were Phase 1 studies conducted in healthy volunteers, including healthy male participants. The drug is investigational and has not received FDA approval for any use.
PC14586 has been studied in three completed Phase 1 trials: NCT05249348, which examined the effect of food on PC14586 in healthy volunteers and its pharmacokinetics in Japanese volunteers; NCT05523687, an absorption, metabolism, and excretion study in healthy males; and NCT06054464, which investigated the effects of acid-reducing agents on PC14586 pharmacokinetics.
PC14586 is not known to have alternative names. It is a small molecule developed by PMV Pharmaceuticals, Inc. and has been evaluated in Phase 1 clinical trials involving healthy volunteers. No other names for this drug have been reported.