A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Drug: SR419
2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
|
| Experimental: Repeated Dose Treatment Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days. |
Drug: SR419
2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
|
Outcome Measures
Primary Outcome Measures
- Peak plasma concentration of SR419 [Up to Day 12]
- Time of peak plasma concentration of SR419 [Up to Day 12]
- Area under the plasma concentration-time curve of SR419 [Up to Day 12]
- Apparent total clearance of SR419 [Up to Day 12]
- Terminal half-life of SR419 [Up to Day 12]
- Accumulation ratio of SR419 [Up to Day 12]
Secondary Outcome Measures
- Peak plasma concentration of SR419 metabolites [Up to Day 12]
- Time of peak plasma concentration of SR419 metabolites [Up to Day 12]
- Area under the plasma concentration-time curve of SR419 metabolites [Up to Day 12]
- Terminal half-life of SR419 metabolites [Up to Day 12]
- Accumulation ratio of SR419 metabolites [Up to Day 12]
- Number of participants with adverse events [Up to Day 15]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy males or females who are 18 to 64 years of age inclusive, are eligible.
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Body weight > 50 kg (110 pounds) and body mass index (BMI) between 18 and 30 kg/m2.
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Male or female subjects must agree to use contraception methods.
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Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
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Clinically significant history of central nervous system (CNS) disease.
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Current or chronic history of liver disease or known hepatic or biliary abnormalities
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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.
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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.
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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.
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History of asthma (excluding resolved childhood asthma), anaphylaxis or anaphylactoid reactions, severe allergic responses.
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History of hypercoagulable state or history of thrombosis.
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A positive Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus (HIV) antibody result.
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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.
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A positive drug/alcohol result.
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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).
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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.
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A positive pregnancy test result.
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Breast-feeding and/or lactating subject.
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Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CMAX Clinical Research | Adelaide | Australia | 5000 |
Sponsors and Collaborators
- SIMR (Australia) Biotech Pty Ltd.
Investigators
- Principal Investigator: Thomas Polasek, CMAX Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SR419-103