Clinical trial NCT03714568: Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.
Official title: Pharmacokinetic and Tolerance Study in Healthy Participants: a Single-centre, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetic
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To study the single dose and multi-doses pharmacokinetic characteristics and tolerance of TQ-A3326 in the human body；To study the transformation of TQ-A3326；To study the effect of the food on the pharmacokinetic characteristics of TQ-A3326.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female, age 18 to 60 years, inclusive.
* The body weight of male is not less than 50kg, and female is not less than 45kg. All participants' body mass index (BMI) is between 19\~26.
* Adequate blood cell counts, kidney function and liver function.
* Healthy participants should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

* Subjects with known allergy to the similar products tested.
* Subject is on a special diet (for example subject is vegetarian).
* Medical demographics with evidence of clinically significant deviation from normal medical condition.
* Female subjects who were pregnant or nursing.
* Results of laboratory tests which are clinically significant.
* Acute infection within one week preceding first study drug administration.
* History of drug or alcohol abuse.
* Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
* Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
* ale subjects (or their partner) or female subjects have the unprotective sex behavior or have a planned pregnancy during the trial.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs).
timeFrame: Day 1 up to Day 7 for non-SAEs .
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements.
timeFrame: Day 1 up to Day 7 or Discharge.
measure: Number of Participants With Marked Abnormalities in Laboratory Findings.
timeFrame: Day 1 up to Day 7.
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax).
timeFrame: Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1
measure: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]).
timeFrame: Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.
measure: Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time.
timeFrame: Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.
measure: Time to Reach Maximum Plasma Concentration (Tmax).
timeFrame: Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.
measure: Plasma Half-life (T-half)
timeFrame: Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.
measure: Apparent Total Body Clearance (CLT/F)
timeFrame: Pre-dose, 0.25hour, 0.5hour, 1hour, 1.5hour, 2hour, 3hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour, 72hour, 96hour, 120hour post-dosing on Day 1.
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Hospital of Changsha
state: Hunan
Study officials:
References: