The purpose of this study is to investigate the safety and tolerability of IX-01 after multiple doses, and to determine how the body handles IX-01.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Hammersmith Medicines Research (HMR)
London, United Kingdom
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Time frame: Baseline to Day 20 (Estimated up to 3 weeks)
Peak Plasma Concentration (Cmax) of IX-01
Time frame: Pre-dose to 24 hours post dose on Days 1 and 10
Area Under the Plasma Concentration-Time Curve (AUCtau)
Time frame: Pre-dose up to 24 hours post dose on Days 1 and 10
Time of Peak Plasma Concentration (Tmax) of IX-01
Time frame: Pre-dose to 24 hours post dose on Days 1 and 10
Elimination Half Life (t1/2) of IX-01
Time frame: Pre-dose up to 96 hours post dose on Day 10
Accumulation Ratio (Racc) of IX-01 based on AUCtau
Time frame: Pre-dose up to 24 hours post dose on Day 10
Accumulation Ratio (Racc) of IX-01 based on Cmax
Time frame: Pre-dose up to 24 hours post dose on Days 1 and 10
Area Under the Concentration-Time Curve (AUCt) from Zero to the Time of Last Quantifiable Concentration (AUC(0-t)) of IX-01
Time frame: Pre-dose to 96 hours post dose on Day 10
Minimum Observed Concentration (Ctrough) of IX-01
Time frame: Pre-dose on Days 2 to 10
Elimination Rate Constant (Kel) of IX-01
Time frame: Pre-dose up to 96 hours post dose on Day 10
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Apparent Clearance of IX-01
Time frame: Pre-dose up to 24 hours post dose on Day 10
Apparent Volume of Distribution During the Terminal Phase of IX-01
Time frame: Pre-dose up to 96 hours post dose on Day 10
Urine 6-β-hydroxycortisol/cortisol Ratio
Time frame: Pre-dose on Day 1 and Day 10
IX-01 Concentration and Amount Secreted in Semen
Time frame: Between 2 and 4 hours after dosing, on Day 9