Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
Lead Sponsor:
Gesynta Pharma AB
Collaborating Sponsors:
CTC Clinical Trial Consultants AB
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral dose...
Detailed Description
Part I (SAD); In the SAD part of the study, single oral doses of GS-248 will be administered in 6 sequential cohorts, each consisting of 8 subjects randomised to receive either GS 248 or placebo in a ...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent for participation in the study.
- Male and female healthy subjects aged 18-70 years inclusive (Part I \[SAD\]) and 40-75 years inclusive (Part II \[MAD\])
- Women of child bearing potential must practice abstinence or must agree to use a highly effective method of contraception with a failure rate of \< 1% to prevent pregnancy from at least 4 weeks prior to dose to 4 weeks after last dose. Their male partner must agree to use a condom during the same time frame. Women of non-childbearing potential are defined as pre-menopausal females who are sterilised or post-menopausal defined as 12 months of amenorrhea.
- Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence. Their female partner of child-bearing potential must use contraceptive methods with a failure rate of \< 1% to prevent pregnancy (see above).
- Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2.
- Subjects must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator.
Exclusion
- Known allergy to any components of the GS-248 formulation.
- Females who are breast feeding or plan to be pregnant.
- Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) at screening and within 24 h prior to the first administration of Investigational Medicinal Product (IMP).
- Use of corticosteroids (inhaled and systemic), NSAIDs (including e.g. coxibs and aspirin), antacids, Proton pump inhibitors (PPIs) or any medication that changes gastric pH within 2 weeks prior to the (first) administration of IMP.
- Regular use of any prescribed or non-prescribed medication including analgesics, herbal remedies, vitamins and minerals within 2 weeks prior to the (first) administration of IMP, except hormonal contraception and occasional intake of paracetamol (maximum 2000 mg/day; and not exceeding 3000 mg/week) and nasal decongestants without cortisone, antihistamine or anticholinergics for a maximum of 10 days, at the discretion of the Investigator.
- Inherited or acquired disorders of platelet function, bleeding or coagulation.
- Presence of any clinically relevant acute or chronic disease that could interfere with the subject's safety during the clinical study or expose the subject to undue risk.
- After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure \<90 or \>140 mmHg, or
- Diastolic blood pressure \<50 or \>90 mmHg, or
- Pulse \<40 or \>90 bpm
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
- Presence or history of drug and/or alcohol abuse and/or excessive intake of alcohol and/or history, or current use, of anabolic steroids, as judged by the Investigator.
- Any positive result for drug abuse and/or alcohol at screening or on admission to the unit prior to administration of the IMP.
- Participation in another clinical study with an experimental drug within 3 months before the administration of IMP.
- Consumption of grapefruit or grapefruit juice within 14 days of study drug administration.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
- Any planned major surgery within the duration of the study.
- Prolonged QTcF (\>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before screening visit.
- Regular excessive caffeine consumption defined by a daily intake of \>5 cups of caffeine containing beverages.
- Intake of xanthine and/or taurine containing energy drinks within 2 days prior to screening.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04036227
Start Date
July 3 2019
End Date
December 20 2019
Last Update
October 11 2023
Active Locations (1)
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1
CTC Clinical Trial Consultants AB
Uppsala, Sweden, SE-75237