GNS561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. The formulation used was oral capsule.The objective of this study in healthy volunteers is to compare pharmacokinetics, safety and tolerability of different formulations (tablets and capsules) and dosage (50 and 200mg) of GNS561 after single oral administration in first part and to evaluate the food effect on pharmacokinetics in second part.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Two formulations and Two dosage will be compared
Genoscience Pharma
Marseille, France
Incidence of Treatment-Emergent Adverse Events
adverse events
Time frame: from first administration until 29 days
Maximum Plasma Concentration (Cmax)
blood samples at different time from GNS561 administration
Time frame: Day 1, Day 2, Day 3, Day 4 and Day 7
Maximum Plasma Concentration (Cmax)
blood samples at different time from GNS561 administration
Time frame: Day 1, Day 2, Day 3, Day 4 and Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.