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COMPLETED
NCT03105375
EARLY_PHASE1

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

Sponsor: Cinclus Pharma Holding AB

View on ClinicalTrials.gov

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.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2017-02-21

Completion Date

2017-10-12

Last Updated

2026-06-17

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Clinical Trial Consultants

Uppsala, Sweden