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

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170311
• Other study ID #: Z213-01
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2014
• Last updated: March 19, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Z-213

Locations

Country	Name	City	State
Japan	Zeria Investigative Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No