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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04941781 | PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers | PHASE1 | COMPLETED | 6 | — | — | Sep 1, 2021 | Nov 10, 2021 | Oct 5, 2022 | 1 | United Kingdom |
| NCT04725175 | Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers | PHASE1 | COMPLETED | 70 | — | — | Feb 26, 2021 | Sep 1, 2021 | Nov 3, 2021 | 1 | Australia |
Number of participants with TEAEs
| Arm | Type | Description |
|---|---|---|
| PIPE-307 | EXPERIMENTAL | Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of \[11C\] PIPE- 307. |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PIPE-307 | DRUG | Each dose cohort will receive a single oral dose of PIPE-307. Doses to be tested in subsequent cohorts will be determined by the analysis of the exposure from PK data and the PET scans with \[11C\] PIPE-307. Subjects will receive an intravenous dose of the radioligand \[11C\] PIPE-307 prior to PET imaging. |
| Placebo oral tablet | DRUG | Single and multiple ascending oral doses of matching Placebo tablets |
Key Criteria: * Normotensive male or female volunteers between 25-65 years old * Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine Key Exclusion Criteria: * Clinically relevant abnormal findings at the screening asse...