Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06362642 | A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants | PHASE1 | COMPLETED | 12 | — | — | Mar 28, 2024 | Oct 22, 2024 | Nov 13, 2024 | 1 | United States |
| NCT06054464 | A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants | PHASE1 | COMPLETED | 28 | — | — | Sep 19, 2023 | Feb 6, 2024 | Nov 13, 2024 | 1 | United States |
| NCT05249348 | Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers | PHASE1 | COMPLETED | 34 | — | — | Dec 20, 2021 | Jun 9, 2022 | Nov 13, 2024 | 1 | United States |
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.
| 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. |
| 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. |
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....