Immune System Disorder (Healthy Volunteer)Phase 1NCT05918627
A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects
A Phase 1 study testing Belumosudil mesylate in people with Immune System Disorder (Healthy Volunteer), run by Kadmon, a Sanofi Company at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Disorder (Healthy Volunteer)
- What is being tested?
- Belumosudil mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2009to 9 Dec 2009
- 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
- Healthy participants between the ages of 18 and 55 years, inclusive.
- Able to provide written informed consent prior to the performance of any study specific procedures.
- Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
- Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.
- The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Examine the Safety, Tolerability and Pharmacokinetic Profile of Single Oral Doses of SLx-2119 in Healthy Male Subjects
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.
Read the detailed description
Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.
- Being tested
- Belumosudil mesylate, Placebo
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belumosudil mesylateDrug
Also called SLx-2119, KD025, SAR445761
Pharmaceutical form: capsule; Route of administration: oral
PlaceboDrug
Pharmaceutical form: capsule; Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1 Receives: Drug: Belumosudil mesylate; Drug: Placebo |
| Dose level 2 | Experimental | Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1 Receives: Drug: Belumosudil mesylate; Drug: Placebo |
| Dose level 3 | Experimental | Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1 Receives: Drug: Belumosudil mesylate; Drug: Placebo |
| Dose level 4 | Experimental | Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1 Receives: Drug: Belumosudil mesylate; Drug: Placebo |
| Dose level 5 | Experimental | Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1 Receives: Drug: Belumosudil mesylate; Drug: Placebo |
| Dose level 6 | Experimental | Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1 Receives: Drug: Belumosudil mesylate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events and serious adverse events
Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
Measured: Day 1 up to approximately 30 days after participant is treated with the last dose of study drug.
Secondary outcomes (5)
Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
Cmax is maximum plasma concentration determined directly from the concentration time profile
Measured: Predose and multiple timepoints up to 24 hours postdose on Day 1
tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
tmax is observed time to reach peak plasma concentration
Measured: Predose and multiple timepoints up to 24 hours postdose on Day 1
AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose
Measured: Predose and multiple timepoints up to 24 hours postdose on Day 1
AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity
Measured: Predose and multiple timepoints up to 24 hours postdose on Day 1
t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
t1/2 is terminal elimination half-life
Measured: Predose and multiple timepoints up to 24 hours postdose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start21 Sep 2009
- Primary completion9 Dec 2009
- Study completion9 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System Disorder (Healthy Volunteer)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadmon, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918627
- Sponsor's protocol ID
- SLx-2119-09-01
- Other IDs
- U1111-1291-6021
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Examine the Safety, Tolerability and Pharmacokinetic Profile of Single Oral Doses of SLx-2119 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05918627
- Acronym / sponsor ID
- SLx-2119-09-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kadmon, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2009 (actual)
- Primary completion
- 9 Dec 2009 (actual)
- Study completion
- 9 Dec 2009 (actual)
- First posted
- 26 Jun 2023 (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 purpose of this study is to determine the safety, tolerability, and pharmacokinetics of multiple doses of SLx-2119 in healthy male participants.
Detailed description
Duration per participants is Day 1 up to 30 days after participant is treated with the last dose of study drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: Belumosudil mesylate, Drug: PlaceboSingle Oral Doses of 20 mg SLx-2119 or placebo on Day 1 |
| Dose level 2 | Experimental | Drug: Belumosudil mesylate, Drug: PlaceboSingle Oral Doses of 40 mg SLx-2119 or placebo on Day 1 |
| Dose level 3 | Experimental | Drug: Belumosudil mesylate, Drug: PlaceboSingle Oral Doses of 80 mg SLx-2119 or placebo on Day 1 |
| Dose level 4 | Experimental | Drug: Belumosudil mesylate, Drug: PlaceboSingle Oral Doses of 160 mg SLx-2119 or placebo on Day 1 |
| Dose level 5 | Experimental | Drug: Belumosudil mesylate, Drug: PlaceboSingle Oral Doses of 320 mg SLx-2119 or placebo on Day 1 |
| Dose level 6 | Experimental | Drug: Belumosudil mesylate, Drug: PlaceboSingle Oral Doses of 640 mg SLx-2119 or placebo on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants between the ages of 18 and 55 years, inclusive.
- Able to provide written informed consent prior to the performance of any study specific procedures.
- Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.
Key exclusion criteria (4 listed)
- Participants are excluded from the study if any of the following criteria apply:
- Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
- Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.
- The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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 |
|---|---|---|
| Belumosudil mesylateAlso: SLx-2119, KD025, SAR445761Pharmaceutical form: capsule; Route of administration: oral | Drug | Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5, Dose level 6 |
| PlaceboPharmaceutical form: capsule; Route of administration: oral | Drug | Dose level 1, Dose level 2, Dose level 3, Dose level 4, Dose level 5, Dose level 6 |
Primary outcome
Number of participants with adverse events and serious adverse events
Time frame: Day 1 up to approximately 30 days after participant is treated with the last dose of study drug.
Safety observations and measurements include AEs, safety laboratory tests, vital sign measurements, physical examinations, and ECGs.
5 secondary outcomes
Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
Time frame: Predose and multiple timepoints up to 24 hours postdose on Day 1
tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
Time frame: Predose and multiple timepoints up to 24 hours postdose on Day 1
AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
Time frame: Predose and multiple timepoints up to 24 hours postdose on Day 1
AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
Time frame: Predose and multiple timepoints up to 24 hours postdose on Day 1
t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047)
Time frame: Predose and multiple timepoints up to 24 hours postdose on Day 1
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 26 Jun 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
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 Belumosudil mesylate in people with Immune System Disorder (Healthy Volunteer), run by Kadmon, a Sanofi Company 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 4 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 26 Jun 2023. 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?
Number of participants with adverse events and serious adverse events (time frame: Day 1 up to approximately 30 days after participant is treated with the last dose of study drug.). 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 26 Jun 2023.