This study is a four-part, single-center, Open label phase I clinical study to characterize the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in Chinese healthy volunteers. This study also aims to evaluate the safety and tolerability of GP681 in the presence of Rosuvastatin, Digoxin, Itraconazole, or Oseltamivir.
GP681 is a potent polymerase acidic (PA) protein endonuclease inhibitor. This study will be run in four parts to characterize the DDIs potential of GP681 with the expected concomitant drugs (Rosuvastatin, Digoxin, Itraconazole, Oseltamivir) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period, and a follow-up telephone call for safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
GP681, tablet, oral
Rosuvastatin, tablet, oral
Digoxin, tablet, oral
China-Japan Friendship Hospital
Beijing, China
Part one: Peak plasma concentration (Cmax) of Rosuvastatin
Time frame: Day 1 to Day 4, and Day 8 to Day 11
Part one: Area under the plasma concentration versus time curve (AUC) of Rosuvastatin
Time frame: Day 1 to Day 4, and Day 8 to Day 11
Part two: Peak plasma concentration (Cmax) of Digoxin
Time frame: Day 1 to Day8, and Day 15 to Day 22
Part two: Area under the plasma concentration versus time curve (AUC) of Digoxin
Time frame: Day 1 to Day 8, and Day 15 to Day 22
Part three: Peak plasma concentration (Cmax) of GP681
Time frame: Day 1 to Day12, and Day26 to Day 37
Part three: Area under the plasma concentration versus time curve (AUC) of GP681
Time frame: Day 1 to Day 12, and Day26 to Day 37
Part Four: Peak plasma concentration (Cmax) of GP681
Time frame: 264 hours after GP681 administration
Part Four: Area under the plasma concentration versus time curve (AUC) of GP681
Time frame: 264 hours after GP681 administration
Part Four: Peak plasma concentration (Cmax) of Oseltamivir
Time frame: 12 hours after Oseltamivir administration
Part Four: Area under the plasma concentration versus time curve (AUC) of Oseltamivir
Time frame: 12 hours after Oseltamivir administration
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Itraconazole, capsule, oral
Oseltamivir, capsule, oral