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A Study to Evaluate the Dose-proportionality and Effects of FG-4592 in Healthy Young and Elderly Male and Female Subjects

NCT02161796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-06-12

No results posted yet for this study

Summary

This study evaluates the concentration of FG-4592 in the blood over a certain period after the intake of different doses, and assesses the effects, the safety and the tolerability of the study drug in healthy young and elderly male and female subjects.

On Day 1 of each of 4 periods subjects receive different single doses of FG-4592 or a placebo, depending on the treatment sequence to which they are randomized. For each period the subjects remain in the clinic for 6 days (Days -2 to 4). They are discharged after all assessments are completed on Day 4 of each period, and return for an End of Study visit (ESV) between 5 and 9 days after the last assessment of Period 4.

Conditions

  • PK for FG-4592
  • Healthy Subjects

Interventions

DRUG

FG-4592

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • FibroGen

    collaborator INDUSTRY

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT02161796 on ClinicalTrials.gov