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

NCT02170311 | Completed Phase 1

• 1 other identifier: Z213-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Z-213 100mg

EXPERIMENTAL

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

Drug: Z-213

Z-213 500mg

EXPERIMENTAL

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

Drug: Z-213

Z-213 800mg

EXPERIMENTAL

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

Drug: Z-213

Z-213 1000mg

EXPERIMENTAL

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

Drug: Z-213

Interventions

Z-213 DRUG

Z-213 1000mg; Z-213 100mg; Z-213 500mg; Z-213 800mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with mild iron deficiency anemia

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Zeria Investigative Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zeria Investigator

  Zeria Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

JP (1)