- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170311
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
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
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Tokyo, Japan
- Zeria Investigative Site
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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 |
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EXPERIMENTAL: Z-213 100mg
Group/Cohort Label: 100 mg iron Z-213 will be administered by intravenous infusion.
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EXPERIMENTAL: Z-213 500mg
Group/Cohort Label: 500 mg iron Z-213 will be administered by intravenous infusion.
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EXPERIMENTAL: Z-213 800mg
Group/Cohort Label: 800 mg iron Z-213 will be administered by intravenous infusion.
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EXPERIMENTAL: Z-213 1000mg
Group/Cohort Label: 1000 mg iron Z-213 will be administered by intravenous infusion.
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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
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8days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z213-01
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.
Clinical Trials on Iron Deficiency Anemia
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Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
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Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
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King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
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Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
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Children's Hospital Los AngelesWithdrawnAnemia | Iron-deficiency Anemia | Healthy ControlsUnited States
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Luzerner KantonsspitalRecruitingIron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron DeficienciesSwitzerland
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Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron Deficiency Anaemia Due to Dietary CausesUnited States
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Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
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Swiss Federal Institute of TechnologyUniversity of MalawiCompletedIron-deficiency | Iron Deficiency AnemiaMalawi, Switzerland
Clinical Trials on Z-213
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Zeria PharmaceuticalCompleted
-
Zeria PharmaceuticalCompletedIron Deficiency AnemiaJapan
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University of California, DavisCompleted
-
Jürgen WeissUnknown
-
University of OxfordUnknownEbola Virus DiseaseUnited Kingdom
-
Zeria PharmaceuticalCompletedAdvanced Hepatocellular CarcinomaJapan
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Everfront Biotech Co., Ltd.Active, not recruitingAmyotrophic Lateral SclerosisTaiwan
-
Zeria PharmaceuticalCompletedPrimary Hypophosphatemic RicketsJapan
-
University of WashingtonCompletedHypertrophic Scarring After Burn InjuryUnited States
-
Zeria PharmaceuticalTerminated