To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials.
This is a single center, randomized, open-label, two-arm, parallel design, phase I study that using TG-2349 or DAG181 alone, or TG-2349 plus DAG181 to evaluate the drug-drug reactions, the pharmacokinetics, and tolerability profile in healthy Chinese volunteers. The results will be the reference for protocol designs of subsequent clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Dosing period 1 (Day 1 to 7): TG-2349 400 mg; Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
Dosing period 1 (Day 1 to 7): DAG181 200 mg; Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
Xiangya Hospital Central South University
Changsha, Hunan, China
Cmax(ss)
Maximum Plasma Concentration in a stable state
Time frame: 14 weeks
Ctrough(ss)
Trough Plasma Concentration in a stable state
Time frame: 14 weeks
AUC(0-τ, ss)
Area Under the Plasma Concentration vs. Time Curve
Time frame: 14 weeks
Cmax
Cmax: Maximum Plasma Concentration,
Time frame: 14 weeks
Ctrough
Ctrough: Trough Plasma Concentration
Time frame: 14 weeks
Tmax
Time at Which Maximum Plasma Concentration is Observed
Time frame: 14 weeks
AUC(0-24)
AUC(0-24): Area Under the Plasma Concentration vs. Time Curve 0-24 hours
Time frame: 14 weeks
Tmax(ss)
Tmax(ss): Time at Which Maximum Plasma Concentration is Observed in a stable state
Time frame: 14 weeks
λz
λz: Terminal disposition rate constant/terminal rate constant
Time frame: 14 weeks
AUC(0-last)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC(0-last): Area Under the Plasma Concentration vs. Time Curve 0 - the last dose
Time frame: 14 weeks
AUC(0-inf)
AUC(0-inf): Area Under the Plasma Concentration vs. Time Curve 0 - infinity
Time frame: 14 weeks
MRT
MRT: mean residence time
Time frame: 14 weeks
CL/F
CL/F: total clearance rate
Time frame: 14 weeks
V/F
V/F: apparent volume of distribution
Time frame: 14 weeks
DF
DF=(Cmax - Ctrough) / (AUCss /τ)
Time frame: 14 weeks
12-lead ECG
including heart rate, RR, PR, QRS, QT, QTc;
Time frame: 19 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
CTCAE v4.0
Time frame: 19 weeks
blood pressure (mmHg)
Vital signs
Time frame: 19 weeks
pulse (beats/ min)
Vital signs
Time frame: 19 weeks
respiratory rate (breaths/ min)
Vital signs
Time frame: 19 weeks
body temperature (oC)
Vital signs
Time frame: 19 weeks
General Appearance Physical examination
Physical examination
Time frame: 19 weeks
Skin Physical examination
Physical examination
Time frame: 19 weeks
Head and Neck Physical examination
Physical examination
Time frame: 19 weeks
Chest region Physical examination
Physical examination
Time frame: 19 weeks
Abdominal region Physical examination
Physical examination
Time frame: 19 weeks
Back region Physical examination
Physical examination
Time frame: 19 weeks
Extremities Physical examination
Physical examination
Time frame: 19 weeks