AnemiaPhase 1NCT00360425
A Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
A Phase 1 study testing ferumoxytol and moxifloxacin in people with Anemia, run by AMAG Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as evaluate pharmacokinetics Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- ferumoxytol and moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Aug 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females, 18 - 45 years of age, inclusive.
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial.
- Subjects must give written informed consent and sign Health Insurance Portability and Accountability Act (HIPAA) guidelines to be in the study.
- Hemoglobin ≥ 10 g/dL and ≤ 16 g/dL for males and ≥ 10 g/dL and ≤ 14 g/dL for females.
- Transferrin saturation (TSAT) ≤ 35%
- Serum ferritin ≤ 100 ng/mL.
- Subjects must have a body mass index (BMI) between 19.0 and 30.0 kg/m2
- Subjects must have no clinically significant abnormal findings on the physical examination.
Who cannot join
- Subjects currently participating in a clinical trial with another investigational new drug or device or who have received an investigational new drug or device within 30 days or 5 half-lives (whichever is longer) prior to randomization into this study.
- Subjects who have been on parenteral or oral iron therapy within 30 days prior to dosing.
- Subjects with active infections requiring ongoing treatment.
- Subjects with a positive human immunodeficiency virus type 1 or type 2 (HIV-1 or HIV-2) antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test.
- Abnormal liver function tests.
- Subjects who have had malignancy (except for non-melanoma of the skin), unless the subject has received curative treatment and has been disease free for > 2 years.
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- Subjects with a history of risk factors for Torsades de pointes (TdP) [e.g., family history (parents or siblings) of long QT syndrome], history of fainting, unexplained loss of consciousness or convulsions.
- Clinically relevant abnormality on screening ECG
- Subjects who have a sustained supine systolic blood pressure (SBP) > 150 mmHg or < 90 mmHg or a diastolic blood pressure (DBP) < 45 or > 95 mmHg at screening or baseline.
- Subjects who have a pulse rate at rest of < 45 bpm or > 100 bpm.
- Subjects who are unable to stop smoking during the study (Day -1 to Day 7). Subjects who smoke 10 or more cigarettes a day.
- Excessive consumption (> 6 units per day) of food or beverages with xanthine or caffeine bases (e.g., tea, coffee, chocolate, cola; 1 unit of caffeine is contained in 6 oz of coffee, 4 oz of energy drink, 24 oz of cola, 12 oz of tea and 3 oz chocolate).
- History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men.
- Subjects with any allergies to iron products, moxifloxacin or multiple drug (two or more) allergies as reported by the subject or as determined by the investigator.
- Subjects who have taken medications [with the exception of Tylenol (acetaminophen) ≤ 2g/day, multi-vitamin that does not contain iron, hormonal contraception for females and hormone replacement therapy (HRT) in the case of menopausal subjects] within 7 days or 5 half-lives (whichever is longer) prior to randomization into this study.
- Subjects who the Investigator determines to have a medical status that would preclude the patient's participation in this protocol or who, for any reason, are deemed by the Investigator to be inappropriate for this study, including subjects who are unable to communicate or to cooperate during the study.
- Subjects with screening lab results that fall outside of the normal range limits and are considered to be clinically significant upon review by the Investigator.
- Subjects who have any condition possibly affecting drug absorption, [e.g., previous surgery on the gastrointestinal tract (including removal of parts of stomach, bowel, liver, gall bladder, or pancreas)].
- Subjects who have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (e.g., stable, mild joint disease) may be made following discussions with the Medical Monitor.
- Subjects who have donated blood or blood components within four weeks prior to the study. The Investigator should instruct subjects who participate in this study not to donate blood or blood components for four weeks after the completion of the study.
- Illegal drug users or subjects who have a history of drug abuse within the last 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Active- and Placebo-Controlled Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as evaluate pharmacokinetics
Read the detailed description
This trial will be conducted in order to provide an evaluation of the potential of ferumoxytol to cause cardiac arrhythmia in accordance with the International Conference on Harmonization (ICH) E14 guidance. The purpose of this trial is to define the effects of ferumoxytol on electrocardiogram (ECG) data. Pharmacokinetics will also be evaluated at multiple time points as specified. Subject safety will be monitored throughout the study.
- Conditions
- Anemia
- Being tested
- ferumoxytol, moxifloxacin, placebo
- Keywords
- anemia, intravenous iron, pharmacokinetics, QTc
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferumoxytolDrug
moxifloxacinDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on the QTcI interval compared to placebo and to a single dose of 400 mg moxifloxacin.
To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on QT, QTcB, QTcF and heart rate (HR).
To assess the pharmacokinetics of two doses of 510 mg ferumoxytol administered within 24 hours.
Secondary outcomes (2)
To describe the relationship between exposure to ferumoxytol and ECG parameters (QTcI, QT, QTcB, QTcF and HR).
To assess the safety and tolerability of a supratherapeutic dose of ferumoxytol (2 doses of 510 mg ferumoxytol administered within 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startMay 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 174 participants
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360425
- Sponsor's protocol ID
- 62,745-9
- Status last verified
- Apr 2022
- First submitted
- 2 Aug 2006
- Last updated
- 4 Apr 2022
- Results posted
- No
Publications
Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
PubMed 16088081
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Active- and Placebo-Controlled Study of the Electrocardiogram Effects and Pharmacokinetics of Ferumoxytol in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT00360425
- Acronym / sponsor ID
- 62,745-9
- Conditions
- Anemia
- Keywords
- anemia, intravenous iron, pharmacokinetics, QTc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants
- Lead sponsor
- AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will define the effects of ferumoxytol on electrocardiogram (ECG) data as well as evaluate pharmacokinetics
Detailed description
This trial will be conducted in order to provide an evaluation of the potential of ferumoxytol to cause cardiac arrhythmia in accordance with the International Conference on Harmonization (ICH) E14 guidance. The purpose of this trial is to define the effects of ferumoxytol on electrocardiogram (ECG) data. Pharmacokinetics will also be evaluated at multiple time points as specified. Subject safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult males and females, 18 - 45 years of age, inclusive.
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial.
- Subjects must give written informed consent and sign Health Insurance Portability and Accountability Act (HIPAA) guidelines to be in the study.
- Hemoglobin ≥ 10 g/dL and ≤ 16 g/dL for males and ≥ 10 g/dL and ≤ 14 g/dL for females.
- Transferrin saturation (TSAT) ≤ 35%
Key exclusion criteria (21 listed)
- Subjects currently participating in a clinical trial with another investigational new drug or device or who have received an investigational new drug or device within 30 days or 5 half-lives (whichever is longer) prior to randomization into this study.
- Subjects who have been on parenteral or oral iron therapy within 30 days prior to dosing.
- Subjects with active infections requiring ongoing treatment.
- Subjects with a positive human immunodeficiency virus type 1 or type 2 (HIV-1 or HIV-2) antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test.
- Abnormal liver function tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferumoxytol | Drug | – |
| moxifloxacin | Drug | – |
| placebo | Drug | – |
Primary outcome
To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on the QTcI interval compared to placebo and to a single dose of 400 mg moxifloxacin.
To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on QT, QTcB, QTcF and heart rate (HR).
To assess the pharmacokinetics of two doses of 510 mg ferumoxytol administered within 24 hours.
2 secondary outcomes
To describe the relationship between exposure to ferumoxytol and ECG parameters (QTcI, QT, QTcB, QTcF and HR).
To assess the safety and tolerability of a supratherapeutic dose of ferumoxytol (2 doses of 510 mg ferumoxytol administered within 24 hours).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 16088081Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
- National Kidney FoundationLink provided by the sponsor.
- National Anemia Action CouncilLink provided by the sponsor.
- Kidney Disease Outcomes Quality InitiativeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ferumoxytol and moxifloxacin in people with Anemia, run by AMAG Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the effect of two doses of 510 mg ferumoxytol administered within 24 hours on the QTcI interval compared to placebo and to a single dose of 400 mg moxifloxacin.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.