Pharmacokinetic and Tolerance Study of TQ-A3326 in Healthy Participants.

NCT03714568 | Unknown Phase 1

• 1 other identifier: ZDTQ-A3326-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Serious Adverse Events (SAEs).

  SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

  Day 1 up to Day 7 for non-SAEs .

• Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements.

  Participants were assessed by investigator for any clinically significant changes in vital parameters like body temperature, respiratory rate, blood pressure, heart rate and weight. The assessment was performed by a calibrated sphygmomanometer and thermometer for blood pressure and temperature, respectively. Blood pressure and heart rate were measured after at least 5 minutes quiet seating of the subject. Weight was measured at the discharge. The criteria for clinically significant change was as per the investigators discretion.

  Day 1 up to Day 7 or Discharge.

• Number of Participants With Marked Abnormalities in Laboratory Findings.

  Laboratory marked abnormalities were defined as Hematocrit (low) as \<0.85\*pre-treatment value, Leukocytes (low) as \<0.9\*lower limit of normal, Aspartate Aminotransferase (high) as \>1.25\*upper limit of normal, Creatinine (high) as \>1.33\*pre-treatment value, Bicarbonate (high) as \>1.2\*upper limit of normal, Total Protein (high) as \>1.1\*upper limit of normal, Creatinine Kinase (high) as \>1.5\*upper limit of normal, Blood in Urine (high) as ≥ 2\*upper limit of normal. Participants were fasted for at least 10 hours prior to the collection of blood specimens for clinical laboratory tests.

  Day 1 up to Day 7.

Secondary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax).

  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

• Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-T]).

  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.

• Area Under the Plasma Concentration-time Curve From Time Zero (AUC[INF]) Extrapolated to Infinite Time.

  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.

• Time to Reach Maximum Plasma Concentration (Tmax).

  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.

• Plasma Half-life (T-half)

  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.

Study Arms (2)

TQ-A3326

EXPERIMENTAL

TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）

Drug: TQ-A3326

placebo

EXPERIMENTAL

Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)

Drug: placebo

Interventions

TQ-A3326 DRUG

TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）

TQ-A3326

placebo DRUG

Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, 410015, China

RECRUITING

MeSH Terms

Interventions

TQ-A3326

Central Study Contacts

Li Xin, Doctor

CONTACT

+86-731-85171383; naloxone@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: October 22, 2018
• Study Start: November 11, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-07

Locations

CN (1)