A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects
NCT ID: NCT05918627
Last Updated: 2023-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2009-09-21
2009-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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Dose level 1
Single Oral Doses of 20 mg SLx-2119 or placebo on Day 1
Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Dose level 2
Single Oral Doses of 40 mg SLx-2119 or placebo on Day 1
Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Dose level 3
Single Oral Doses of 80 mg SLx-2119 or placebo on Day 1
Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Dose level 4
Single Oral Doses of 160 mg SLx-2119 or placebo on Day 1
Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Dose level 5
Single Oral Doses of 320 mg SLx-2119 or placebo on Day 1
Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Dose level 6
Single Oral Doses of 640 mg SLx-2119 or placebo on Day 1
Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Interventions
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Belumosudil mesylate
Pharmaceutical form: capsule; Route of administration: oral
Placebo
Pharmaceutical form: capsule; Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Kadmon, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational site
Baltimore, Maryland, United States
Countries
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Other Identifiers
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U1111-1291-6021
Identifier Type: OTHER
Identifier Source: secondary_id
SLx-2119-09-01
Identifier Type: -
Identifier Source: org_study_id
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