Healthy VolunteersPhase 1NCT06270511
A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants
A Phase 1 study testing S-337395 in people with Healthy Volunteers, run by Shionogi at 1 site in United States.
Trial summary
The aim of this study is to investigate different formulations of S-337395. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- S-337395
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2024to 19 Jun 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body mass index within the range of 18.5 to approximately 30.0 kilograms/meter squared (inclusive) at screening.
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.
Who cannot join
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
- Lymphoma, leukemia, or any malignancy in the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Sensitivity to S-337395, or any components of the formulation, or drug or other allergy, that in the opinion of the investigator, contraindicates participation in the study.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part Study to Evaluate the Relative Bioavailability of and Food-Effect on Pharmacokinetics of Different Formulations of S-337395, and to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of S-337395 in Healthy Adult Participants
The aim of this study is to investigate different formulations of S-337395.
Read the detailed description
This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.
- Conditions
- Healthy Volunteers
- Being tested
- S-337395, Placebo
- Keywords
- S-337395, Bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-337395Drug
Administered as an oral suspension.
PlaceboDrug
Administered as an oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Open Label | Experimental | Participants will receive different formulations of S-337395 without food and with food. Receives: Drug: S-337395 |
| Part B: Double Blind | Experimental | Participants will receive S-337395 or placebo. Receives: Drug: S-337395; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Plasma Concentration of S-337395
Measured: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
Part B: Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Day 21
Secondary outcomes (3)
Part A: Number of Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Day 29
Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)
Measured: Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose)
Part B: Plasma Concentration of S-337395
Measured: Days 1-12 (Predose, up to 96 hours post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start13 Mar 2024
- Primary completion30 May 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270511
- Sponsor's protocol ID
- 2222T1412
- Status last verified
- Jul 2024
- First submitted
- 13 Feb 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part Study to Evaluate the Relative Bioavailability of and Food-Effect on Pharmacokinetics of Different Formulations of S-337395, and to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of S-337395 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06270511
- Acronym / sponsor ID
- 2222T1412
- Conditions
- Healthy Volunteers
- Keywords
- S-337395, Bioavailability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 21 Feb 2024 (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.
The aim of this study is to investigate different formulations of S-337395.
Detailed description
This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Open Label | Experimental | Drug: S-337395Participants will receive different formulations of S-337395 without food and with food. |
| Part B: Double Blind | Experimental | Drug: S-337395, Drug: PlaceboParticipants will receive S-337395 or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body mass index within the range of 18.5 to approximately 30.0 kilograms/meter squared (inclusive) at screening.
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.
Key exclusion criteria (6 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
- Lymphoma, leukemia, or any malignancy in the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Sensitivity to S-337395, or any components of the formulation, or drug or other allergy, that in the opinion of the investigator, contraindicates participation in the study.
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 |
|---|---|---|
| S-337395Administered as an oral suspension. | Drug | Part A: Open Label, Part B: Double Blind |
| PlaceboAdministered as an oral suspension. | Drug | Part B: Double Blind |
Primary outcome
Part A: Plasma Concentration of S-337395
Time frame: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
Part B: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 21
3 secondary outcomes
Part A: Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 29
Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)
Time frame: Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose)
Part B: Plasma Concentration of S-337395
Time frame: Days 1-12 (Predose, up to 96 hours post dose)
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 10 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 S-337395 in people with Healthy Volunteers, run by Shionogi at 1 site in United States.
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 3 inclusion and 6 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 10 Jul 2024. 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 United States. 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?
Part A: Plasma Concentration of S-337395 (time frame: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)). The study lists 2 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 10 Jul 2024.