Preliminary evaluate of pharmacokinetics, pharmacodynamics, safety and tolerability after oral administration of AJH-2947 in healthy Korean or Caucasian male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Oral Tablet, Single dose of AJH-2947 100 mg
Oral Tablet, Single dose of Placebo 100 mg
Oral Tablet, Single dose of AJH-2947 200 mg
Seoul National University Hospital
Seoul, South Korea
Part A (SAD): Plasma concentrations of AJH-2947
To characterize the plasma concentration of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 5
Part A (SAD): Urine concentrations of AJH-2947
To characterize the urine concentration of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 4
Part A (SAD): Maximum observed concentration [Cmax]
To characterize the Cmax of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants
Time frame: Day 1 to Day 5
Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration [AUClast]
To characterize the AUClast of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 5
Part A (SAD): Time to reach peak or maximum observed concentration [Tmax]
To characterize the Tmax of AJH-2947 after single oral dosing in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 5
Part B (MAD): Plasma concentrations of AJH-2947
To characterize the plasma concentration of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 18
Part B (MAD): Maximum observed concentration [Cmax]
To characterize the Cmax of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
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Oral Tablet, Single dose of Placebo 200 mg
Oral Tablet, Single dose of AJH-2947 300 mg
Oral Tablet, Single dose of Placebo 300 mg
Oral Tablet, Single dose of AJH-2947 400 mg
Oral Tablet, Single dose of Placebo 400 mg
Oral Tablet, Single dose of AJH-2947 600 mg
Oral Tablet,Single dose of Placebo 600 mg
Oral Tablet, Single dose of AJH-2947 800 mg
Oral Tablet, Single dose of Placebo 800 mg
Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 200 mg
Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 200 mg
Oral Tablet,Multiple (once daily for 7days) oral dose of AJH-2947 400 mg
Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 400 mg
Oral Tablet, Multiple (once daily for 7days) oral dose of AJH-2947 600 mg
Oral Tablet, Multiple (once daily for 7days) oral dose of Placebo 600 mg
Time frame: Day 1 to Day 18
Part B (MAD): The partial area from dosing time to dosing time plus dosing interval [AUCτ]
To characterize the AUCτ of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 18
Part B (MAD): Time of maximum observed concentration [Tmax]
To characterize the Tmax of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 18
Part B (MAD): Maximum observed concentration occurring at time Tmax,ss [Cmax,ss]
To characterize the Cmax,ss of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 18
Part B (MAD): At steady state, the partial area from dosing time to dosing time plus dosing interval [AUCτ,ss]
To characterize the AUCτ,ss of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day 1 to Day 18
Part B (MAD): Heat pain Threshold (The temperature at which the subject first perceives pain, ℃)
Heat pain Threshold is determined by gradually increased the temperature of the thermal probe on non-sensitized and casaicin-sensitized skin starting from 30 ℃ as the baseline using Thermal NeuroSensory Analyzer. (The cutoff limit is set at 50°C)
Time frame: Predose, Day 1, Day 7, and Day 8
Part B (MAD): Heat pain tolerance (The Maximum temperature that the subject can tolerate, ℃)
Heat pain tolerance is determined by gradually increased the temperature of the thermal probe on non-sensitized and casaicin-sensitized skin starting from 30 ℃ as the baseline using Thermal NeuroSensory Analyzer. (The cutoff limit is set at 50°C)
Time frame: Predose, Day 1, Day 7, and Day 8
Part A (SAD): Number of participants with adverse events (AE)
To assess the safety and tolerability of AJH-2947 following oral administration of single ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day -1, Day 1 to day 12 (last visit)
Part A (SAD): Number of participants with serious adverse events (SAE)
To assess the safety and tolerability of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day -1, Day 1 to day 18 (last visit)
Part B (MAD): Number of participants with AE
To assess the safety and tolerability of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day -1, Day 1 to day 18 (last visit)
Part B (MAD): Number of participants with SAE
To assess the safety and tolerability of AJH-2947 following oral administration of multiple ascending doses in healthy Korean and Caucasian male participants.
Time frame: Day -1, Day 1 to day 18 (last visit)