The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data following single ascending and multiple ascending doses of X842 in healthy subjects.
This is a single-centre, open label, first-in-human study with the primary objective to evaluate safety and tolerability of X842 after administration of single and multiple oral ascending doses to healthy male and female subjects. The study comprises a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part including an open-label multiple dose cohort administered active comparator (omeprazole). Four subjects will be included in each of the SAD and MAD cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
39
Each subject in a the same cohort will be assigned to the same single dose of X842. The subjects in the subsequent cohort will be assigned to a single dose of X842 based on safety and efficacy data generated from the previous cohort.
Each subject in a the same cohort will be assigned to the same dose of X842 once daily for five days. The subjects in the subsequent cohort will be assigned to same dose of X842 once daily for five days based on safety and efficacy data generated from the previous cohort.
Each subject in one cohort will be assigned to a standard dose of omeprazole once daily for five days.
Clinical Trial Consultants
Uppsala, Sweden
Occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination after single and multiple doses of X842. Summary statistics will be applied.
Safety and tolerability will be assessed by occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination. The adverse event assessment will follow the recommendations and grading system of Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Summary statistics will be applied.
Time frame: Five weeks
Measurement of the PK profile (Cmax)
To assess the Maximum Plasma Concentration (Cmax)
Time frame: Up to 48 hours after dosing
Measurement of the PK profile (t1/2)
To assess the plasma half life (t1/2) of drug
Time frame: Up to 48 hours after dosing
Measurement of the PD profile (intragastric pH)
To assess and characterize the PD profile with measurements of intragastric pH
Time frame: Up to 24 hours after dosing
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