Immune System Disorder (Healthy Volunteer)
Conditions
Brief summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.
Detailed description
Up to approximately 58 days including safety follow up period of 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
PARALLEL
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. * Female who is not of reproductive potential. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events and serious adverse events | Up to approximately 58 days | Number of participants with adverse events and serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | tmax, observed time to reach peak plasma concentration |
| Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | Cmin, Minimum or trough plasma concentration after its administration and just prior to the administration of a subsequent dose as determined from the concentration time cprofile |
| AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | AUC0 -τis area under the plasma concentration-time curve from predose (time 0) to end of dosing collection (30 hours) |
| Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | Cmax maximum plasma concentration determined directly from the concentration time profile |
| Accumulation ratio (R) of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | Accumulation ratio, determined as the ratio of Day 28 AUC divided by Day 1 AUC and as the ratio of Day 28 Cmax divided by Day 1 Cmax |
| t1/2 of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | t1/2 terminal elimination half-life |
| AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)] | Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28 | AUCinf, area under the concentration-time curve from predose (time 0) extrapolated to Infinity |
Countries
United States
Outcome results
None listed