This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers
This is an exploratory, first-in-human (FIH), double-blind, randomized, placebo-controlled, single and multiple ascending oral dose study in healthy volunteers.The study will be divided into two parts that will be conducted sequentially. Part A is a SAD study to determine the safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In addition, the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098. Part B is a MAD study to determine the safety, tolerability and PK of BVL-GSK098 following multiple daily oral doses in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Oral QD
CIM Sant Pau
Barcelona, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
All AEs will be counted and described within each cohort/dose level, by treatment received and tabulated.
Time frame: From screening visit (Day -3 to -30) to end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in hematology parameters
Blood samples will be collected for the assessment of hematology parameters.
Time frame: Day 1 until end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in clinical chemistry parameters
Blood samples will be collected for the assessment of chemistry parameters.
Time frame: Day 1 until end of study (7-10 days post last dose)
Number of participants with urinalysis findings
Urine samples will be collected for the assessment of urinalysis parameters.
Time frame: Day 1 until end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in vital signs
Number of participants with abnormal vital signs will be assessed.
Time frame: Day 1 until end of study (7-10 days post last dose)
Number of participants with clinically significant abnormal findings in Electrocardiogram (ECG) Parameters
Triplicate 12-lead ECGs will be obtained
Time frame: Day 1 until end of study (7-10 days post last dose)
Maximum observed plasma drug concentration (Cmax) of BVL-GSK098
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood samples will be collected to evaluate Cmax of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
Time to maximum observed plasma drug concentration (tmax) of BVL-GSK098
Blood samples will be collected to evaluate tmax of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
Area under the plasma drug concentration versus time curve (AUC) of BVL-GSK098
Blood samples will be collected to evaluate AUC of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
Apparent terminal half-life (t1/2) of BVL-GSK098 as appropriate
Blood samples will be collected to evaluate t1/2 of BVL-GSK098
Time frame: Single dose: up to 72 hours; Multiple dose: up to 10 days
The effect of food on the plasma concentrations of BVL-GSK098
Blood samples will be collected to evaluate the food effect on plasma concentrations of BVL-GSK098
Time frame: up to 72 hours
Observed accumulation ratio following BVL-GSK098 repeat dosing
Time frame: up to 10 days