Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Coronary Syndrome Stroke

Keywords

antiplatelet drugshear stressSP-8008

Outcome Measures

Primary Outcomes (3)

Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with serious adverse drug reactions (SADRs)
The number of subject who experienced a serious adverse drug reaction
Follows up to 7 days
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with severe adverse drug reactions (ADRs)
The number of subject who experienced a severe adverse drug reaction
Follows up to 7 days
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with clinically significant non-serious adverse events (AEs)
The number of subject who experienced a clinically significant non serious adverse event
Follows up to 7 days

Secondary Outcomes (4)

To evaluate the effect of single dose SP-8008 on platelet function through Shear stress-induced platelet aggregation (SIPA)
Follows up to 48 hours
To evaluate the effect of single dose SP-8008 on platelet function through inhibition of platelet aggregation (IPA)
Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 in health male subjects. - Peak Plasma Concentration (Cmax)
Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 in health male subjects. - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Follows up to 48 hours

Other Outcomes (3)

Laboratory measures of von Willebrand Factor (VWF) activity through Shear stress-induced platelet aggregation (SIPA)
Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 metabolites- Peak Plasma Concentration (Cmax)
Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 metabolites- Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Follows up to 48 hours

Study Arms (6)

Cohort 1: 200mg SP-8008 Prototype Capsule A

EXPERIMENTAL

Treat 200 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo.

Drug: SP-8008 Prototype Capsule ADrug: Placebo

Cohort 2: 400mg SP-8008 Prototype Capsule A

EXPERIMENTAL

Treat 400 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo.

Drug: SP-8008 Prototype Capsule ADrug: Placebo

Cohort 3: 800mg SP-8008 Prototype Capsule A

EXPERIMENTAL

Interventions

SP-8008 Prototype Capsule ADrug

Oral

Also known as: SP-8008

Cohort 1: 200mg SP-8008 Prototype Capsule ACohort 2: 400mg SP-8008 Prototype Capsule ACohort 3: 800mg SP-8008 Prototype Capsule A

SP-8008 Prototype Capsule BDrug

Eligibility Criteria

Age18 Years - 55 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsMale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy males
Age 18 to 55 years of age at the time of signing informed consent

Sponsors & Collaborators

Shin Poong Pharmaceutical Co. Ltd.
Industrylead

Study Sites (1)

Quotient Sciences

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

MeSH Terms

Conditions

Acute Coronary SyndromeStroke

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

Stuart Mair, MD
Quotient Sciences
PRINCIPAL INVESTIGATOR

Enrollment

48 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

You may not qualify if:

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
+5 more criteria

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SP-8008

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (6)

Cohort 1: 200mg SP-8008 Prototype Capsule A

Cohort 2: 400mg SP-8008 Prototype Capsule A

Cohort 3: 800mg SP-8008 Prototype Capsule A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 4: 800 mg SP-8008 Prototype Capsule B

Cohort 5: 1200 mg SP-8008 Prototype Capsule B

Cohort 6: 1800 mg SP-8008 Prototype Capsule B

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Other Outcomes (3)

Study Arms (6)

Cohort 1: 200mg SP-8008 Prototype Capsule A

Cohort 2: 400mg SP-8008 Prototype Capsule A

Cohort 3: 800mg SP-8008 Prototype Capsule A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 4: 800 mg SP-8008 Prototype Capsule B

Cohort 5: 1200 mg SP-8008 Prototype Capsule B

Cohort 6: 1800 mg SP-8008 Prototype Capsule B

You may not qualify if:

Source record

Locations