Safety and tolerability study of APRG64.
- Registration Number
- CTRI/2021/06/033961
- Lead Sponsor
- GENENCELL CO LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1.Healthy adult males aged 20 - 45 years (both inclusive) of age during the time of screening.
(Medically healthy without clinically significant abnormalities at the screening visit).
2.Subject who has body weight >= 60 kg where the weight shall be within ± 20% of the ideal body weight range considering the height of the subject himself.
3.Those who agree to use appropriate contraception and not to donate the sperm during the clinical study period and up to 3 months after the end of the study.
4.Participate voluntarily after listening to the detailed explanation of this clinical trial and fully understand it, and give a written agreement with the cautions of the subject during the clinical trial period.
1.Self- reported history or presence of significant hepatic, renal, neurological, endocrine, hematological, tumor, urinary, cardiovascular, musculoskeletal, and mental diseases, gastrointestinal diseases or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of IP, chronic Hepatitis type B and C, Genetic problems with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, etc.
2.Documented hypersensitivity reaction or anaphylaxis to IP
3.Unfit for screening through a medical examination.
4.Laboratory test results showing Hemoglobin (Hb) more than 13.0 g/dL, AST or ALT more than 3 times of the NUL,total bilirubin more than 1.5 times of NUL,CPK more than 1.5 times of NUL, Estimated Glomerular Filtration Rate less than 60 mL/min/1.73 m2
6.BP outside normal range, a person with a QTcB interval greater than 450ms in a 12-lead ECG test.
7.The use of any medication, alcohol, or drug abuse by urine drug test.
8.Excessive intake of caffeine and alcohol, smoker
9.Received IP from other clinical research study within 90 days prior to administration of IP.
10. Take drugs inducing or inhibiting IP metabolic enzymes.
11.Donated whole blood 60 days prior to administration of IP, or donated component blood within 30 days prior to administration of IP.
12.Consumed grapefruit-containing food within 14 days prior to administration of IP.
13.Consumed any special medicine or herbal medicine that may affect the characteristics of IP within two weeks prior to the first administration date, or taken Over-the-counter drug (OTC) or vitamin supplements within one week prior to the first administration date.
14.Unable to cooperate fully with the requirements of the study protocol.
15.Those who were judged to be ineligible for participation in the clinical study by the investigator due to other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of AE s/ concomitant medication <br/ ><br>2.Number of SAEs <br/ ><br>3.Physical examination (body examination, height, weight and BMI) <br/ ><br>4.Vital signs <br/ ><br>5.Clinical laboratory tests (Hematological tests, Blood biochemistry tests, Urine tests) <br/ ><br>6.12-lead ECG <br/ ><br>Timepoint: SAD: Day 1,2,3,8,15 <br/ ><br>MAD: Day 1,2,3,4,5,6,7,12,19
- Secondary Outcome Measures
Name Time Method noneTimepoint: none