NCT03105375

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Human: A Single/Multiple Ascending Dose Study

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Healthy Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Cinclus Pharma AG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Single ascending dose of X842	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.
DRUG	Multiple ascending dose of X842	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.
DRUG	Losec	Each subject in one cohort will be assigned to a standard dose of omeprazole once daily for five days.

Timeline

• Start date: 2017-02-21
• Primary completion: 2017-10-12
• Completion: 2017-10-12
• First posted: 2017-04-07
• Last updated: 2017-11-07

Locations

1 site across 1 country: Sweden