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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04150224 | Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169 | PHASE1 | COMPLETED | 60 | — | — | Jul 3, 2018 | Feb 1, 2019 | Feb 28, 2020 | 1 | Russia |
Safety and tolerability: number of (S)AEs
Safety and tolerability: number of subjects with adverse events
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (C1A), PBTZ169 | EXPERIMENTAL | Two doses of PBTZ169: 640 mg OD fasted and 640 mg OD after meal. Wash-out period ≥6 days. |
| Cohort 1 (C1B), PBTZ169 | EXPERIMENTAL | Two doses of PBTZ169: 640 mg OD after meal and 640 OD mg fasted. Wash-out period ≥6 days. |
| Cohort 2 (C2), PBTZ169 | EXPERIMENTAL | Single dose of PBTZ169: 960 mg fasted |
| Cohort 3 (C3), PBTZ169 | EXPERIMENTAL | Two doses of PBTZ169: 640 mg twice a day (fasted) with a 12-hour interval; total daily dose - 1280 mg |
| Cohort 4 (C4), PBTZ169 | EXPERIMENTAL | Single dose of PBTZ169: 1280 mg fasted |
| Cohort 5 (C5), PBTZ169 | EXPERIMENTAL | Multiple administration of PBTZ169: 1280 mg once a day after meal for 14 days |
| Name | Type | Description |
|---|---|---|
| PBTZ169 640 mg OD | DRUG | Two administrations once a day with a wash-out period: food effect |
| PBTZ169 640 mg BiD | DRUG | Twice a day fasted; 1 day of administration |
| PBTZ169 960 mg SD | DRUG | Once a day fasted |
| PBTZ169 1280 mg SD | DRUG | Once a day fasted |
| PBTZ169 1280 mg MD | DRUG | Once a day after meal, 14 doses |
Inclusion Criteria: 1. Written informed consent from the volunteer. 2. Men and women aged 18-45 years, inclusive. 3. Body mass index of 18.5-30 kg/m2. 4. Verified "healthy" diagnosis based on physical examination, vital signs, standard laboratory tests (complete blood count and biochemical blood te...