Status:
COMPLETED
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SP-8008
Lead Sponsor:
Shin Poong Pharmaceutical Co. Ltd.
Conditions:
Acute Coronary Syndrome
Stroke
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a single-centre, double-blind, randomised, placebo-controlled single oral-dose escalation study in healthy male subjects. It is planned to enrol approximately 48 subjects into up to 6 planned ...
Detailed Description
Investigational medicinal product (IMP) will be administered at only 1 dose level at a time. Following each of Periods 1, 2, 3, 4, and 5, there will be a period of interim analysis and review of safet...
Eligibility Criteria
Inclusion
- Healthy males
- Age 18 to 55 years of age at the time of signing informed consent
- Body mass index of 18.0 to 32.0 kg/m2 as measured at screening
- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), electrocardiogram (ECG) and laboratory investigations (haematology, coagulation, clinical chemistry and urinalysis) and bleeding time (bleeding time may be measured on Day 1)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Exclusion
- Female subjects
- Subjects who had received any investigator medicinal product (IMP) in a clinical research study within the 3 months or 90 days prior to Day 1
- Subjects who were study site employees, or immediate family members of a study site or sponsor employee
- Subjects who had previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- Current smokers and those who had smoked within the last 12 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm at screening or admission Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
- Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
- Subjects without suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator including investigator medicinal product (PT) \>14 s, investigator medicinal product (aPTT) \> reference laboratory values, platelet count ≤100,000 mm3, alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \>2× upper limit of normal, white blood cells ≤3000 × 109/L, haemoglobin \<11 g/dL, total bilirubin \>20 µmol/L, bleeding time \>15 min
- Any clinically significant medical disorders increasing the tendency to bleed easily, or a history of recent trauma or surgery, or a history of gout and renal stones
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated Creatinine Clearance (CrCl) of \<80 mL/min using the Cockcroft-Gault equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Serious adverse reaction (SAE) or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who were taking, or had taken, any prescribed or over-the-counter drug, herbal remedies or supplements in the 14 days before IMP administration; these included fish oil/Omega-3, St. John's wort, ginseng, garlic, gingko, saw palmetto, echinacea, yohimbine, liquorice and black cohosh. Exceptions may have applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the principal investigator (PI) and sponsor's medical monitor.
- Failure to satisfy the investigator of fitness to participate for any other reason
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04770194
Start Date
October 1 2019
End Date
January 23 2020
Last Update
February 25 2021
Active Locations (1)
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1
Quotient Sciences
Nottingham, Nottinghamshire, United Kingdom, NG11 6JS