- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04705077
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
March 24, 2021 updated by: SIMR (Australia) Biotech Pty Ltd.
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
This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers.
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adelaide, Australia, 5000
- CMAX Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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/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 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Dose Treatment
Each subject will be assigned to the fixed period sequence.
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2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
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EXPERIMENTAL: Repeated Dose Treatment
Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days.
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2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak plasma concentration of SR419
Time Frame: Up to Day 12
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Up to Day 12
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Time of peak plasma concentration of SR419
Time Frame: Up to Day 12
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Up to Day 12
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Area under the plasma concentration-time curve of SR419
Time Frame: Up to Day 12
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Up to Day 12
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Apparent total clearance of SR419
Time Frame: Up to Day 12
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Up to Day 12
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Terminal half-life of SR419
Time Frame: Up to Day 12
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Up to Day 12
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Accumulation ratio of SR419
Time Frame: Up to Day 12
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Up to Day 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak plasma concentration of SR419 metabolites
Time Frame: Up to Day 12
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Up to Day 12
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Time of peak plasma concentration of SR419 metabolites
Time Frame: Up to Day 12
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Up to Day 12
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Area under the plasma concentration-time curve of SR419 metabolites
Time Frame: Up to Day 12
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Up to Day 12
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Terminal half-life of SR419 metabolites
Time Frame: Up to Day 12
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Up to Day 12
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Accumulation ratio of SR419 metabolites
Time Frame: Up to Day 12
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Up to Day 12
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Number of participants with adverse events
Time Frame: Up to Day 15
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Up to Day 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Polasek, CMAX Clinical Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 2, 2021
Primary Completion (ACTUAL)
March 12, 2021
Study Completion (ACTUAL)
March 12, 2021
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (ACTUAL)
January 12, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 25, 2021
Last Update Submitted That Met QC Criteria
March 24, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- SR419-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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