This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers.
This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers. The study will enroll approximately 16 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
oral, apelin receptor (APJ) agonist
New Zealand Clinical Research
Auckland, New Zealand
Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-t
Assessment of PK parameter, area under the curve (AUC) from time 0 to time of the last observed serum concentration (AUC0-t)
Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Pharmacokinetics of azelaprag (BGE-105) after multiple-dose (Part 2) - AUC0-24
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)
Time frame: Study Part 2, Predose and post dose to 24 hours after the final dose is received.
Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-inf
Assessment of PK parameter, UAC from time 0 to infinity (AUC0-inf)
Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Pharmacokinetics of azelaprag (BGE-105) after oral administration - Cmax
Assessment of PK parameter, maximum observed serum concentration (Cmax)
Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Pharmacokinetics of azelaprag (BGE-105) after oral administration - Tmax
Assessment of PK parameter, time to reach Cmax (Tmax)
Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Pharmacokinetics of azelaprag (BGE-105) after oral administration - T1/2
Assessment of PK parameter, terminal elimination half-life (T1/2)
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Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Oral bioavailability of azelaprag after oral administration - Total body clearance
Assessment of PK parameter, Total body clearance (CL)
Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Oral bioavailability of azelaprag after oral administration - Volume of distribution
Assessment of PK parameter, volume of distribution (Vz)
Time frame: Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.
Safety of azelaprag after oral administration - TEAEs
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: First dose to Day 21