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| Name | Class |
|---|---|
| R&G Pharma Studies Co.,Ltd. | INDUSTRY |
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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.
This study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile in healthy Chinese volunteers with single or multiple ascending oral doses of TG-2349 (Furaprevir capsule). The study is separated into two parts, part A and part B.
Part A:To evaluate the safety, tolerability, and PK profile of single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 in healthy Chinese volunteers.
Part B:To evaluate the safety, tolerability, and PK profile of multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 for five days in healthy Chinese volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furaprevir capsule (SAD) | Experimental | single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule) |
|
| Placebo (SAD) | Placebo Comparator | Single ascending oral dose of Furaprevir similar capsule. . |
|
| Furaprevir capsule (MAD) | Experimental | multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule) |
|
| Placebo (MAD) | Placebo Comparator | Multiple ascending oral doses of Furaprevir similar capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 12-lead ECG (electrocardiogram) | 10 days | |
| blood pressure (mmHg) | Vital signs | 10 days |
| pulse (beats/ min) |
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Inclusion Criteria:
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 representativeï¼›
Male or female, and 18 to 45 years of age inclusive when signing ICFï¼›
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 screeningï¼›
For females, one of the following criteria must be fulfilled
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)ï¼›
Have not used tobacco or nicotine-containing products within 1 month prior to the first dose of study drugï¼›
Have not drunk alcohol beverages or drank alcoholic beverages less than 12 times within 3 months prior to the first dose of study drugï¼›
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pingsheng Xu, PhD | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | China |
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|
| 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. |
|
|
| Placebo (SAD) | Drug | Each subject will receive the sample once by oral administration. |
|
| 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. |
|
Vital signs |
| 10 days |
| respiratory rate (breaths/ min) | Vital signs | 10 days |
| body temperature (oC) | Vital signs | 10 days |
| General Appearance Physical examination | Physical examination | 10 days |
| Skin Physical examination | Physical examination | 10 days |
| Head and Neck Physical examination | Physical examination | 10 days |
| Chest region Physical examination | Physical examination | 10 days |
| Abdominal region Physical examination | Physical examination | 10 days |
| Back region Physical examination | Physical examination | 10 days |
| Extremities Physical examination | Physical examination | 10 days |
| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| C110804 | mycophenolic adenine dinucleotide |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
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