The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
6
DRC Ltd.
Balatonfüred, Hungary
PRA Magyarorszag Kft
Budapest, Hungary
Maximum observed plasma concentration (Cmax)
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours post-dose
Time frame: up to 48 hours
Time to maximum observed plasma concentration (Tmax)
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Time frame: up to 48 hours
Percentage of estimated Area Under the Curve (0-inf)
Measure specified pharmacokinetic parameters pre-dose and out to 48 hours
Time frame: up to 48 hours
Treatment emergent adverse events (TEAEs)
TEAEs will be listed and summarized by dose and overall
Time frame: 7 days post-dose
Clinical laboratory data
Clinical laboratory data will be listed with flagging of values outside the normal range
Time frame: 7 days post-dose
Vital signs
descriptive statistics will be provided to summarize vital signs and changes from baseline by dose at each scheduled time
Time frame: 7 days post-dose
12-Lead Electrocardiogram (ECG)
Descriptive statistics will be provided to summarize ECG parameters
Time frame: 7 days post-dose
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