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Single Ascending Oral Dose Phase I Study With Px-102

NCT01998659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-11-04

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.

Conditions

  • Healthy

Interventions

DRUG

Px-102

Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg

DRUG

Placebo

Oral drinking solution

Sponsors & Collaborators

  • Phenex Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Claus Kremoser, Dr. · Phenex Pharmaceuticals AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01998659 on ClinicalTrials.gov