Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia

March 19, 2015 updated by: Zeria Pharmaceutical

"Phase Ib Study of Z-213 in Subjects With Iron-deficiency Anemia - To Investigate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics -"

The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tokyo, Japan
        • Zeria Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with mild iron deficiency anemia

Exclusion Criteria:

  • Patients with anemia caused by conditions other than iron deficiency
  • Patients with abnormal laboratory test values at screening for C-reactive protein, Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin
  • Patients with liver, kidney or circulatory system disease
  • Patients with a history or present illness that is a malignant tumor or autoimmune disease
  • Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
  • Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Z-213 100mg
Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.
EXPERIMENTAL: Z-213 500mg
Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.
EXPERIMENTAL: Z-213 800mg
Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.
EXPERIMENTAL: Z-213 1000mg
Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of total serum iron (Cmax), (Tmax), (AUC0-t), (AUC0-24),(AUC0-72),(T1/2), (CL), (Vd, area), (Vd, ss), (MRT) or total urine iron (CLren), (Ae).
Time Frame: 8days
8days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Zeria Investigator, Zeria Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (ESTIMATE)

June 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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