HealthyPhase 1NCT04705077
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
A Phase 1 study testing SR419 in people with Healthy, run by SIMR (Australia) Biotech Pty Ltd. at 1 site in Australia.
Trial summary
This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SR419
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Feb 2021to 12 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- SR419
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR419Drug
2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Treatment | Experimental | 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). Receives: Drug: SR419 |
| Repeated Dose Treatment | Experimental | Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days. Receives: Drug: SR419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration of SR419
Measured: Up to Day 12
Time of peak plasma concentration of SR419
Measured: Up to Day 12
Area under the plasma concentration-time curve of SR419
Measured: Up to Day 12
Apparent total clearance of SR419
Measured: Up to Day 12
Terminal half-life of SR419
Measured: Up to Day 12
Accumulation ratio of SR419
Measured: Up to Day 12
Secondary outcomes (6)
Peak plasma concentration of SR419 metabolites
Measured: Up to Day 12
Time of peak plasma concentration of SR419 metabolites
Measured: Up to Day 12
Area under the plasma concentration-time curve of SR419 metabolites
Measured: Up to Day 12
Terminal half-life of SR419 metabolites
Measured: Up to Day 12
Accumulation ratio of SR419 metabolites
Measured: Up to Day 12
Number of participants with adverse events
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start2 Feb 2021
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIMR (Australia) Biotech Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Polasek, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705077
- Sponsor's protocol ID
- SR419-103
- Status last verified
- Jan 2021
- First submitted
- 8 Jan 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04705077
- Acronym / sponsor ID
- SR419-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SIMR (Australia) Biotech Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose Treatment | Experimental | Drug: SR419Each 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). |
| Repeated Dose Treatment | Experimental | Drug: SR419Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR4192 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study. | Drug | Repeated Dose Treatment, Single Dose Treatment |
Primary outcome
Peak plasma concentration of SR419
Time frame: Up to Day 12
Time of peak plasma concentration of SR419
Time frame: Up to Day 12
Area under the plasma concentration-time curve 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
Accumulation ratio of SR419
Time frame: Up to Day 12
6 secondary outcomes
Peak plasma concentration of SR419 metabolites
Time frame: Up to Day 12
Time of peak plasma concentration of SR419 metabolites
Time frame: Up to Day 12
Area under the plasma concentration-time curve of SR419 metabolites
Time frame: Up to Day 12
Terminal half-life of SR419 metabolites
Time frame: Up to Day 12
Accumulation ratio of SR419 metabolites
Time frame: Up to Day 12
Number of participants with adverse events
Time frame: Up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Polasek principal investigator
CMAX Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SR419 in people with Healthy, run by SIMR (Australia) Biotech Pty Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration of SR419 (time frame: Up to Day 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.