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

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Z-213

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zeria Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Z-213 100mg

Z-213 500mg

Z-213 800mg

Z-213 1000mg

Arm Description

Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.

Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.

Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.

Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02170311

First Posted

June 10, 2014

Last Updated

March 19, 2015

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT02170311

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Z-213 100mg

Arm Type

Experimental

Arm Description

Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.

Arm Title

Z-213 500mg

Arm Type

Experimental

Arm Description

Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.

Arm Title

Z-213 800mg

Arm Type

Experimental

Arm Description

Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.

Arm Title

Z-213 1000mg

Arm Type

Experimental

Arm Description

Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.

Intervention Type

Drug

Intervention Name(s)

Z-213

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zeria Investigator

Organizational Affiliation

Zeria Pharmaceutical Co., Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Zeria Investigative Site

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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