MedTrace Logo

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

NCT03105375 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-11-07

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

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.

Sponsors & Collaborators

  • Cinclus Pharma AG

    lead INDUSTRY

Principal Investigators

  • Cornelia Lif-Tiberg, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2017-10-12
Completion
2017-10-12

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03105375 on ClinicalTrials.gov