To Evaluate the Safety, Tolerability, and Pharmacokinetics Profile in Healthy Chinese Volunteers of TG-2349

NCT03610867 | Completed Phase 1

• 1 other identifier: TG-2349-C-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.

Conditions

Healthy Chinese Volunteers

Keywords

safety; tolerability; PK; single ascending oral dose; multiple ascending oral doses

Outcome Measures

Primary Outcomes (4)

• Cmax (Maximum Plasma Concentration)

  Maximum Plasma Concentration

  10 days

• Tmax (Time at Which Maximum Plasma Concentration is Observed)

  Time at Which Maximum Plasma Concentration is Observed

  10 days

• AUC (Area Under the Plasma Concentration)

  Area Under the Plasma Concentration

  10 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  CTCAE v4.0

  10 days

Secondary Outcomes (12)

• 12-lead ECG (electrocardiogram)

  10 days

• blood pressure (mmHg)

  10 days

• pulse (beats/ min)

  10 days

• respiratory rate (breaths/ min)

  10 days

• body temperature (oC)

  10 days

Study Arms (4)

Furaprevir capsule (SAD)

EXPERIMENTAL

single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule)

Drug: Furaprevir capsule (SAD)

Placebo (SAD)

PLACEBO COMPARATOR

Single ascending oral dose of Furaprevir similar capsule. .

Drug: Placebo (SAD)

Furaprevir capsule (MAD)

EXPERIMENTAL

multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule)

Drug: Furaprevir capsule (MAD)

Placebo (MAD)

PLACEBO COMPARATOR

Multiple ascending oral doses of Furaprevir similar capsule

Drug: Placebo (MAD)

Interventions

Furaprevir capsule (SAD) DRUG

There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration.

Also known as: TG-2349 (SAD)

Furaprevir capsule (SAD)

Furaprevir capsule (MAD) DRUG

There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.

Also known as: TG-2349 (MAD)

Furaprevir capsule (MAD)

Placebo (SAD) DRUG

Each subject will receive the sample once by oral administration.

Placebo (SAD)

Placebo (MAD) DRUG

Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.

Placebo (MAD)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Before starting the study, an informed consent form (ICF) approved by the Institutional Review Board (IRB) is obtained from the subject or his/her legal representative；
• Male or female, and 18 to 45 years of age inclusive when signing ICF；
• Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 and male body weight ≥ 50 kg, female body weight ≥ 45 kg；
• In generally good physical and mental health status on basis of a medical history review, physical examination and vital signs, 12-lead ECG, and laboratory results at screening；
• For females, one of the following criteria must be fulfilled
• Had undergone surgical sterilization, or
• Subjects of childbearing potential must satisfy the following criteria:
• Before group assignment, the pregnancy test is negative, and Subjects agree to use an approved contraceptive method (i.e. oral spermicidal agent, condoms, or intrauterine devices) during the entire study period (from signing ICF to the last visit). Subjects must also consent to keep the contraceptive method unchanged until 1 month after the study, and Breastfeeding is prohibited
• Males must be willing to use a reliable form of contraception (use of a condom or spouses using any of the above standards) during the entire study period (from signing ICF to the last visit)；
• Have not used tobacco or nicotine-containing products within 1 month prior to the first dose of study drug；
• Have not drunk alcohol beverages or drank alcoholic beverages less than 12 times within 3 months prior to the first dose of study drug；
• Willing to abstain from caffeine- or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges juice before 24 hr and during the Stay-on Site period.

You may not qualify if:

• Current, prior history, or family history of any disease of sudden cardiac death, myocardial ischemia, myocardial infarction, congestive heart failure, QT prolongation syndrome, hypokalemia, myocarditis, exertional dyspnea, cerebrovascular injury, venous thromboembolism；
• Requires concomitant medication associated with increased QTc interval (i.e. Class I or III antiarrhythmic agents or with cardiac insufficiency；
• Any abnormality on 12-lead ECG: PR\>240 ms, PR\<110 ms, QRS\>110 ms, QTc\>450 ms, or bradycardia ( heart rate \< 50 beats/min) at screening or the day -1；
• Any clinical significant abnormality on 12-lead ECG (i.e. atrioventricular block, TdT, other types of ventricular tachycardia, atrial fibrillation and ventricular flutter, clinical significant abnormality on T wave changes or any abnormality on 12-lead ECG that effects QTc intervals) at screening or the day -1；
• Systolic pressure\>140 mmHg or \<90 mmHg, diastolic pressure \>90 mmHg, pulse \<50 beats/min or \>100 beats/min at screening or the day -1；
• Any clinical significant abnormality on chest X-rays or abdominal ultrasound scan at screening；
• Positive serological test for hepatitis A (IgM anti-HAV), hepatitis B (HbsAg), hepatitis C (anti-HCV antibody), or syphilis at screening；
• Pregnant or breastfeeding；
• Any abnormal laboratory values (normal value ±10％) that are considered clinical significant by the Investigator at screening or the day -1；
• Positive breath alcohol test or urine drug screen at screening or the day -1；
• Current or prior history of any disease of diabetes, cardiovascular, hepatic or renal impairment；
• Any malabsorption syndrome or other gastrointestinal disturbances affecting drug absorption；
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy；
• History of epileptic seizure, mental disorders affecting the subject's compliance with the protocol, suicidal risk, or a history of alcohol or illicit drug abuse；
• Currently has any disease that seriously affects the immune system, for instance, human immunodeficiency virus (HIV) infection, hematological malignancy, solid cancer or splenectomy；

Sponsors & Collaborators

• Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.: lead
• R&G Pharma Studies Co.,Ltd.: collaborator

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

MeSH Terms

Interventions

Sagittal Abdominal Diameter; mycophenolic adenine dinucleotide

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Study Officials

• Pingsheng Xu, PhD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

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 6, 2018
• First Posted: August 1, 2018
• Study Start: April 27, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

CN (1)