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

Phase 1

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Z-213

• Registration Number: NCT02170311
• Lead Sponsor: Zeria Pharmaceutical

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-19
• Study First Posted: 2014-06-23
• Primary Completion: 2015-02
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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).	8days

Trial Locations

Locations (1)

Zeria Investigative Site; 🇯🇵 Tokyo, Japan