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, and to Assess the Effect of a High-Fat Meal on the Pharmacokinetics of SR419 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- SR419
- Conditions
- Healthy
- Sponsor
- SIMR (Australia) Biotech Pty Ltd.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Time of peak plasma concentration of SR419
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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, and to assess the effect of a high-fat meal on the pharmacokinetics of SR419 in healthy subjects.The trial will consist of 3 cohorts. Cohort 1 and 2 will follow a single sequence, 3-period, 2-formulation, dosing in fasted or fed state design. Cohort 3 will be a repeated dose study of SR419 capsule in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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/m
- •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 Criteria
- •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.
Arms & Interventions
Single Dose Treatment
Each subject will be assigned to the fixed period sequence. * Period 1: SR419 suspension in the fasted state; * Period 2: SR419 capsule in the fasted state; * Period 3: SR419 capsule in the fed state (high-fat meal).
Intervention: SR419
Repeated Dose Treatment
Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days.
Intervention: SR419
Outcomes
Primary Outcomes
Time of peak plasma concentration of SR419
Time Frame: Up to Day 12
Apparent total clearance of SR419
Time Frame: Up to Day 12
Terminal half-life of SR419
Time Frame: Up to Day 12
Peak plasma concentration of SR419
Time Frame: Up to Day 12
Accumulation ratio of SR419
Time Frame: Up to Day 12
Area under the plasma concentration-time curve of SR419
Time Frame: Up to Day 12
Secondary Outcomes
- Peak plasma concentration of SR419 metabolites(Up to Day 12)
- Terminal half-life of SR419 metabolites(Up to Day 12)
- Time of peak plasma concentration of SR419 metabolites(Up to Day 12)
- Accumulation ratio of SR419 metabolites(Up to Day 12)
- Area under the plasma concentration-time curve of SR419 metabolites(Up to Day 12)
- Number of participants with adverse events(Up to Day 15)