Status:
COMPLETED
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
Lead Sponsor:
SIMR (Australia) Biotech Pty Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers.
Detailed Description
This study is a phase 1, open-label study to assess the single dose pharmacokinetics of suspension and capsule formulations of SR419 and repeat dose pharmacokinetics of capsule formulation of SR419, a...
Eligibility Criteria
Inclusion
- Healthy males or females who are 18 to 64 years of age inclusive, are eligible.
- Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 18 and 30 kg/m2.
- Male or female subjects must agree to use contraception methods.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion
- Clinically significant history of central nervous system (CNS) disease.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities
- History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
- History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
- History of sensitivity to any of the components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
- History of asthma (excluding resolved childhood asthma), anaphylaxis or anaphylactoid reactions, severe allergic responses.
- History of hypercoagulable state or history of thrombosis.
- A positive Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus (HIV) antibody result.
- A positive urinary cotinine test or history of regular use of tobacco- or nicotine-containing products (more than 4 products per month within 6 months prior to screening) or unwilling to refrain from use of such products from Screening until completion of the final study visit.
- A positive drug/alcohol result.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of IMP until the Safety Follow-up visit.
- A positive pregnancy test result.
- Breast-feeding and/or lactating subject.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04705077
Start Date
February 2 2021
End Date
March 12 2021
Last Update
March 25 2021
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, Australia, 5000