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CompletedNCT04705077Updated Mar 25, 2021

A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects

A Phase 1 interventional study of SR419 in Healthy, sponsored by SIMR (Australia) Biotech Pty Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-25.

Sponsored by SIMR (Australia) Biotech Pty Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

This is the only study on the registry with SIMR (Australia) Biotech Pty Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males or females who are 18 to 64 years of age inclusive, are eligible.
  2. Body weight > 50 kg (110 pounds) and body mass index (BMI) between 18 and 30 kg/m2.
  3. Male or female subjects must agree to use contraception methods.
  4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion criteria

Exclusion Criteria:

  1. Clinically significant history of central nervous system (CNS) disease.
  2. Current or chronic history of liver disease or known hepatic or biliary abnormalities
  3. 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.
  4. 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.
  5. 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.
  6. History of asthma (excluding resolved childhood asthma), anaphylaxis or anaphylactoid reactions, severe allergic responses.
  7. History of hypercoagulable state or history of thrombosis.
  8. A positive Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus (HIV) antibody result.
  9. 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.
  10. A positive drug/alcohol result.
  11. 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).
  12. 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.
  13. A positive pregnancy test result.
  14. Breast-feeding and/or lactating subject.
  15. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • Experimental
    Repeated Dose Treatment

    Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days.

    Drug: SR419

Interventions

  • DrugSR419

    2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.

06

What researchers measure

Primary outcomes

  1. Peak plasma concentration of SR419

    Time frame: Up to Day 12

  2. Time of peak plasma concentration of SR419

    Time frame: Up to Day 12

  3. Area under the plasma concentration-time curve of SR419

    Time frame: Up to Day 12

  4. Apparent total clearance of SR419

    Time frame: Up to Day 12

  5. Terminal half-life of SR419

    Time frame: Up to Day 12

  6. Accumulation ratio of SR419

    Time frame: Up to Day 12

Secondary outcomes

  1. Peak plasma concentration of SR419 metabolites

    Time frame: Up to Day 12

  2. Time of peak plasma concentration of SR419 metabolites

    Time frame: Up to Day 12

  3. Area under the plasma concentration-time curve of SR419 metabolites

    Time frame: Up to Day 12

  4. Terminal half-life of SR419 metabolites

    Time frame: Up to Day 12

  5. Accumulation ratio of SR419 metabolites

    Time frame: Up to Day 12

  6. Number of participants with adverse events

    Time frame: Up to Day 15

07

Study locations

1 site
  • CMAX Clinical Research
    Adelaide, 5000, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04705077
Lead sponsor
SIMR (Australia) Biotech Pty Ltd.
Responsible party
Sponsor
First posted
Jan 12, 2021
Start date
Feb 2, 2021
Primary completion
Mar 12, 2021
Completion
Mar 12, 2021
Last update
Mar 25, 2021

Study contacts

Thomas Polasek
principal investigator · CMAX Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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