A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
Time frame: Up to Day 3
CNTX-6970 Pharmacokinetics - AUC0-t
Systemic exposure to CNTX-6970 measured by AUC0-t
Time frame: Up to Day 13
CNTX-6970 Pharmacokinetics - AUC0-inf
Systemic exposure to CNTX-6970 measured by AUC0-inf
Time frame: Up to Day 13
CNTX-6970 Pharmacokinetics - Cmax
Systemic exposure to CNTX-6970 measured by Cmax
Time frame: Up to Day 13
CNTX-6970 Pharmacokinetics - tmax
Systemic exposure to CNTX-6970 measured by tmax
Time frame: Up to Day 13
CNTX-6970 Pharmacokinetics - t1/2
Systemic exposure to CNTX-6970 measured by t1/2
Time frame: Up to Day 13
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Number of participants with TEAEs, which includes laboratory test variables
Time frame: Up to Day 13
CNTX-6970 Pharmacodynamics - Emax
Pharmacodynamic effect on MCP-1 and RANTES measured by Emax
Time frame: Up to Day 13
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CNTX-6970 Pharmacodynamics - PD tmax
Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax
Time frame: Up to Day 13