The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Hammersmith Medicines Research
London, United Kingdom
Relative Bioavailability (Frel) of a Capsule Compared to a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in the Fed State Compared to the Fasted State, as Calculated by a Ratio of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Compared With a Liquid Formulation of IX-01 While Fasting, as Calculated by a Ratio of Peak Plasma Concentrations
Time frame: Pre-dose up to 96 hours post dose
Relative Bioavailability (Frel) of a Capsule Formulation of IX-01 in a Fed State Compared to a Fasted State, as Calculated by a Ratio of Peak Plasma Concentrations
Time frame: Pre-dose up to 96 hours post dose
Area Under the Plasma Concentration Time Curve From Time 0 to Infinity, Following a Single Dose of IX-01
Time frame: Pre-dose and up to 96 hours post dose
Peak Plasma Concentration (Cmax) of IX-01
Time frame: Pre-dose and up to 96 hours post dose
Time to Peak Plasma Concentration (Tmax) of IX-01
Time frame: Pre-dose up to 96 hours post dose
Elimination Half Life (t1/2) of IX-01
Time frame: Pre-dose up to 96 hours post dose
Elimination Rate Constant (Kel) of IX-01
Time frame: Pre-dose up to 96 hours post last dose
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Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Measurable Sample of IX-01
Time frame: Pre-dose to the time of the last measurable sample
Concentration of IX-01 in Cerebrospinal Fluid (CSF) After a Single Dose of the Liquid Formulation of IX-01
Listed by time point of 1, 2, 4, 6 hours post dose
Time frame: 1, 2, 4 and 6 hours after dosing
Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline to study completion (approximately 6 weeks)