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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05720364 | Study to Evaluate the Food Effect of TP-05 in Healthy Participants | PHASE1 | COMPLETED | 42 | — | — | Jan 19, 2023 | May 30, 2023 | Jun 28, 2023 | 1 | United States |
| NCT05138796 | A Pharmacokinetic Study of TP-05 in Healthy Subjects | PHASE1 | COMPLETED | 67 | — | — | May 6, 2021 | Jul 25, 2022 | Aug 3, 2022 | 1 | United States |
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes concentration level.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes AUC0-96hours.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Cmax.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tmax.
PK parameters for whole blood sampling methods following dose administration with a high-fat meal, low-fat meal, and fasting will be evaluated. Parameter includes Tlag.
Evaluate the safety of TP-05 through the incidence rate of TEAEs
Evaluate the safety of TP-05 through clinically significant changes from Baseline chemistry laboratory tests
Evaluate the safety of TP-05 through clinically significant changes from Baseline hematology laboratory tests
Evaluate the safety of TP-05 through clinically significant changes from Baseline general appearance
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of head, ears, nose, and throat
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neck (thyroid)
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of respiratory system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of cardiovascular system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of gastrointestinal system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examinations of neurological system
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of musculoskeletal system (extremities)
Evaluate the safety of TP-05 through clinically significant changes from Baseline physical examination of skin
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs (including temperature \[degrees Celsius\], pulse rate \[beats per minute\], respiration rate \[breaths per minute\], and changes in systolic and diastolic blood pressure \[mmHg\])
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including temperature \[degrees Celsius\]
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including pulse rate \[beats per minute\]
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including respiration rate \[breaths per minute\]
Evaluate the safety of TP-05 through clinically significant changes from Baseline vital signs including changes in systolic and diastolic blood pressure \[mmHg\])
Evaluate the safety of TP-05 through clinically significant changes from Baseline ECGs (including changes in mean ventricular rate \[beats/min\], pulse rate \[msec\], QRS duration \[msec\], QT interval \[msec\], QTcF interval \[msec\])
| Arm | Type | Description |
|---|---|---|
| TP-05, Fasted Group | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral), fasted |
| TP-05, High-Fat Group | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral) following a high-fat meal |
| TP-05, Low-Fat Group | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral) following a low-fat meal |
| TP-05 SAD | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral capsules) at 4 dose levels in ascending order |
| Placebo SAD | EXPERIMENTAL | Single dose of Placebo |
| TP-05 MAD | EXPERIMENTAL | Four doses of TP-05 (lotilaner oral capsules) at 3 dose levels in ascending order |
| Placebo MAD | EXPERIMENTAL | Four doses of Placebo |
| TP-05 Fasted | EXPERIMENTAL | Single dose of TP-05 (lotilaner oral capsules) in a fasted state |
| Placebo Fasted | EXPERIMENTAL | Single dose of placebo in a fasted state |
| Name | Type | Description |
|---|---|---|
| TP-05 (lotilaner oral), fasted group | DRUG | TP-05 (lotilaner oral), fasted group |
| TP-05 (lotilaner oral), high-fat group | DRUG | TP-05 (lotilaner oral), high-fat group |
| TP-05 (lotilaner oral), low-fat group | DRUG | TP-05 (lotilaner oral), low-fat group |
| TP-05 (lotilaner oral capsules) | DRUG | TP-05 (lotilaner oral capsules) |
| Placebo | DRUG | Placebo to match TP-05 (lotilaner oral capsules) |
Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination * Participants who are non- or ex-smokers * No clinically significant disease captuired in medical history or evidence of clinically significant findings...