Clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of JP-1366 oral administration in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg
Seoul National University Hospital(SNUH)
Seoul, Jongno-Gu, South Korea
Cmax
SAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
AUClast
SAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
AUCinf
SAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
tmax
SAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
t1/2
SAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours post-dose
Cmax,ss
MAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
Cmin,ss
MAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
Cav,ss
MAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg
Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg
AUCτ
MAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
tmax,ss
MAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
t1/2
MAD endpoint
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24h post-dose, Day 3-6, pre-dose, Day 7 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hour post-dose
Percentage of total time that the intragastric pH was above 4
SAD
Time frame: 0-24 hours(Day -1), 0-24 hours(Day 1)
Percentage of total time that the intragastric pH was above 4
MAD
Time frame: 0-24 hours (Day -1), 0-24 hours (Day 1), 0-24 hours (Day 7)
Serum gastrin concentration
SAD
Time frame: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose
Serum gastrin concentration
MAD
Time frame: Pre-dose, 2, 4, 6, 8, 12h post-dose, Day 1 pre-dose, 2, 4, 6, 8, 12, 24h post-dose, Day 4 pre-dose, Day 6 pre-dose, Day 7 pre-dose, 2, 4, 6, 8, 12, 24, 48h post-dose