Safety, tolerability, PK and PD study of SP-8008 (QSC200837)

• Research type

  Research Study

• Full title

  A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of SP-8008 in Healthy Male Subjects

• IRAS ID

  258054

• Contact name

  Dr Chung Ju

• Contact email

  cj2013@shinpoong.co.kr

• Sponsor organisation

  Shin Poong Pharm.Co. Ltd

• Eudract number

  2019-000098-21

• Clinicaltrials.gov Identifier

  NCT04770194

• Duration of Study in the UK

  0 years, 3 months, 16 days

• Research summary

  Summary of Research
  The Sponsor is developing the test medicine, SP-8008, as a new antiplatelet agent. The purpose of an antiplatelet agent is to prevent blood clots forming in the body. Blood clots cause blockages in arteries and veins which prevents oxygen from being delivered to tissues and organs via the blood stream and can result in heart attack or stroke.

  This study will look at the safety, tolerability and pharmacokinetics (PK - what the body does to the test medicine) of the test medicine.

  The study will consist of 6 sequential escalating dose cohorts involving approximately 48 healthy male volunteers, with 8 volunteers per cohort. Each cohort will be split into 2 sub-cohorts, with sentinel dosing of 2 volunteers (1 volunteer receiving the test medicine, 1 volunteer receiving a dummy medicine (placebo)) followed by a second dosing of 6 volunteers (5 receiving the test medicine, 1 receiving placebo).

  In Period 1 (Cohort 1), volunteers will be randomly assigned to receive a single 200 mg dose of prototype capsule A of the test medicine, SP-8008, or matching placebo (dummy medicine) to swallow. In subsequent periods, volunteers will receive either increasing dose levels of capsule A or a second formulation (recipe), capsule B. Formulation selection and dose escalation for subsequent cohorts will not begin until safety and tolerability data from the preceding cohort has been evaluated.

  There will be a minimum 14 days between dosing of each cohort.

  Volunteers will remain in the clinical unit until 48 h after dosing, except in the case of an ongoing adverse event which is to be followed up until resolution. Volunteers will return for a follow up visit 5 to 7 days post dose to check their well being.

  Summary of Results
  Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality

• REC name

  Wales REC 2

• REC reference

  19/WA/0131

• Date of REC Opinion

  21 May 2019

• REC opinion

  Favourable Opinion