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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06141889 | Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers | PHASE1 | COMPLETED | 16 | — | — | Nov 17, 2023 | Feb 2, 2024 | Feb 23, 2024 | 1 | New Zealand |
Assessment of PK parameter, area under the curve (AUC) from time 0 to time of the last observed serum concentration (AUC0-t)
Assessment of PK parameter, area under the curve (AUC) over the dosing interval from time 0 to 24 hours following the final dose (AUC0-24)
Assessment of PK parameter, UAC from time 0 to infinity (AUC0-inf)
Assessment of PK parameter, maximum observed serum concentration (Cmax)
Assessment of PK parameter, time to reach Cmax (Tmax)
Assessment of PK parameter, terminal elimination half-life (T1/2)
Assessment of PK parameter, Total body clearance (CL)
Assessment of PK parameter, volume of distribution (Vz)
| Arm | Type | Description |
|---|---|---|
| Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2 | EXPERIMENTAL | Study Part 1: Participants will receive a single Dose A or B on Day 1 and then followed by a crossover to a single Dose B or A on Day 8. Study Part 2: Participants in Study Part 2 will receive either a single Dose C or equivalent of Dose C administered twice daily, starting on Day 1 and through Day 14 |
| Name | Type | Description |
|---|---|---|
| Azelaprag | DRUG | oral, apelin receptor (APJ) agonist |
Key Inclusion Criteria: Patients who meet ALL the following inclusion criteria will be eligible to participate in the study: 1. Healthy male or female volunteers ≥ 60 years of age 2. No history or evidence of clinically relevant medical disorders 3. Body mass index (BMI) between 18 and 40 kg/m2 4....