Immune System Disorder (Healthy Volunteer)
Conditions
Brief summary
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.
Interventions
Pharmaceutical form: capsule; Route of administration: oral
DRUGPlacebo
Pharmaceutical form: capsule; Route of administration: oral
Sponsors
Kadmon, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events and serious adverse events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Predose and multiple timepoints up to 24 hours postdose on Day 1 | Cmax is maximum plasma concentration determined directly from the concentration time profile |
| tmax of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Predose and multiple timepoints up to 24 hours postdose on Day 1 | tmax is observed time to reach peak plasma concentration |
| AUC0-24 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Predose and multiple timepoints up to 24 hours postdose on Day 1 | AUC0-24 is area under the plasma concentration-time curve from predose (time 0) to 24 hours Postdose |
| AUCinf of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Predose and multiple timepoints up to 24 hours postdose on Day 1 | AUCinf is area under the concentration-time curve from predose (time 0) extrapolated to Infinity |
| t1/2 of SLx-2119 and its metabolites (SLx-2131 and SLx-3047) | Predose and multiple timepoints up to 24 hours postdose on Day 1 | t1/2 is terminal elimination half-life |
Countries
United States
Outcome results
None listed