Anemia, Iron DeficiencyPhase 1NCT04626414

Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers

A Phase 1 study testing Ferric maltol capsule and Ferric maltol suspension in people with Anemia, Iron Deficiency, run by Shield Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Anemia, Iron Deficiency
What is being tested?: Ferric maltol capsule and Ferric maltol suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 28 Sep 2020to 13 Nov 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

All of the following criteria must be met for a subject to participate in the study:
Must voluntarily sign and date each Institutional Review Board (IRB)-approved informed consent form (ICF) prior to the initiation of any screening or study-specific procedures.
Willing and able to comply with study requirements.
Healthy adult subjects 18 to 55 years of age, inclusive at the time of informed consent.
Body Mass Index (BMI) of 18-32 kg/m2 inclusive
Female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. All female subjects must have a negative result for the pregnancy tests performed at screening and each treatment period.

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Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implants, injection, ring, or patch) and intrauterine contraceptive devices (IUDs), at least 3 months prior to Screening, or a vasectomized partner.
Note: complete abstinence from sexual intercourse is an acceptable form of contraceptive practice.
Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral, tubal ligation, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or post-menopausal, defined as spontaneous amenorrhea for at least 2 years
Male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to Screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse from Study Day -1 (beginning of confinement) until 3 months after the Follow-up Visit.
Note: Complete abstinence from sexual intercourse is an acceptable form of contraceptive practice.
Male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after administration of the last dose of study drug.

Who cannot join

A subject who meets any of the following criteria is not eligible for participation in the study.
Known hypersensitivity or allergy to the active substance or excipients of Ferric maltol oral suspension or capsules;
Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, as determined by the Investigator;
Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
Recent (within 6 months of screening) history of drug or alcohol abuse;
Positive screen results for drugs of abuse, alcohol at screening or Study Day -1 of Period1;

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Consumption of alcohol within 72 hrs prior to study drug administration;
Positive test result for hepatitis B surface antigen (HBSaAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;
Donation or loss of 550 mL or more blood volume or receipt of a transfusions of any blood product within 8 weeks prior to study drug administration and 14 days for plasma donation unless medically inadvisable;
Use of any over the counter medications, including herbal product within 7 days prior to Screening until study completion. Except for ordinary pain (e.g. headache), some analgesics (mainly paracetamol) and contraception which have no drug interactions with the study products may be given;
Has received within 28 days prior to Screening intramuscular or intravenous (IV) injection or administration of depot iron preparation;
Has received oral iron supplementation within 7 days prior to Screening;
Has concomitant disease that would significantly compromise iron absorption or absorbed iron utilization such as swallowing disorders, gastric pH-disturbance and/or extensive small bowel resection;
Scheduled or expected hospitalization and/or surgery during the course of the study;
Diagnosed to be COVID-19 positive by polymerase chain reaction testing (SARS-CoV-2-RTPCR positive) of a respiratory specimen (preferably a nasopharyngeal swab) on Day -2;
Participation in any other interventional clinical study within 28 days prior to Screening;
Any other unspecified reason that, in the opinion of the Investigator or the Sponsor makes the subject unsuitable for enrolment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Single Dose, Four-Way Crossover, Phase I Study to Compare the Pharmacokinetics of Ferric Maltol Capsules and Oral Suspension Under Fasted and Fed Conditions in Adult Healthy Volunteers

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.

Read the detailed description

Open-label, Phase 1, four way crossover study to compare the PK of the new ferric maltol suspension, in healthy volunteers, with the existing ferric maltol capsules under fed and fasted conditions.

32 subjects will be randomised to 1:1:1:1 ratio to receive one of the treatment sequences.

Based on the randomised sequence, subjects will receive a single dose of 30mg ferric maltol capsule in a fed/ fasted condition and 30 mg (5ml) ferric maltol suspension in a fed/ fasted condition.

Subject participation in the study will consist of 3 periods:

Screening: up to 14 days
Randomised treatment: 8 days
Post-treatment follow up: 3-7 days following drug discontinuation

Conditions: Anemia, Iron Deficiency
Being tested: Ferric maltol capsule, Ferric maltol suspension
Keywords: iron deficiency, anaemia
Medical subject headings: Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferric maltol capsuleDrug
Also called ST10, Feraccru, Accrufer
single dose of 30 mg capsule
Ferric maltol suspensionDrug
Also called ST10
single dose of 30mg (5ml) oral suspension

Study groups in NCT04626414
Study group	Role	What they receive
30 mg ferric maltol capsule in a fed condition	Active comparator	Single dose of 30 mg ferric maltol capsule in a fed condition Receives: Drug: Ferric maltol capsule
30 mg ferric maltol capsule in a fasted condition	Active comparator	Single dose of 30 mg ferric maltol capsule in a fasted condition Receives: Drug: Ferric maltol capsule
30 mg (5 ml) ferric maltol suspension in a fed condition	Experimental	Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition Receives: Drug: Ferric maltol suspension
30 mg (5 ml) ferric maltol suspension in a fasted condition	Experimental	Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition Receives: Drug: Ferric maltol suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Capsule
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg ferric maltol capsule
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Capsule
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30 mg ferric maltol capsule
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Suspension
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Suspension
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days

Secondary outcomes (22)

PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions
Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions
Descriptive statistics of baseline corrected serum iron concentration; area under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Baseline Corrected Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
Descriptive statistics of baseline corrected serum iron concentration; Area Under the Curve from 0-infinity by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions
Descriptive statistics of maltol glucuronide; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol; AUClast in Fasted and Fed Conditions
Descriptive statistics of maltol; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TSAT; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TSAT; AUClast in Fasted and Fed Conditions
Descriptive statistics of transferrin saturation; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TIBC; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TIBC; AUClast in Fasted and Fed Conditions
Descriptive statistics of Total Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Summary of Serious Adverse Events
Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted)
Measured: up to 2 weeks following last dose
PK Analysis of UIBC; Cmax in Fasted and Fed Conditions
Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of UIBC; AUClast in Fasted and Fed Conditions
Descriptive statistics of Unsaturated Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1,1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions
Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions
Descriptive statistics of transferrin; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
Measured: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events from Day 1 to Day 22 (Study completion)
Measured: From first dose of ferric maltol on Day 1 to study completion
TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments
TEAE leading to premature discontinuation of study drug/PK assessments from Day 1 to study completion
Measured: From first dose of ferric maltol on Day 1 to study completion
Vital Signs - Blood Pressure, Change From Day 1 to Day 8
Descriptive statistics for changes in blood pressure from Screening to Day 8
Measured: Screening to Day 8
Vital Signs - Heart Rate, Change From Day 1 to Day 7
Descriptive statistics for changes in heart rate from Screening to Day 7
Measured: Screening to Day 7
Summary of Received Concomitant Medication by Formulation
Number of participants having received concomitant medications by formulation (suspension or capsule)
Measured: Day 1 to Day 8 (24 hrs post-dose of last dosing)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 202013 Nov 2020

First posted12 Nov 2020
Study start28 Sep 2020
Primary completion13 Nov 2020
Study completion13 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anemia, Iron DeficiencyStudies 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: Crossover
Model description: Subjects will be randomized 1:1:1:1 to one of the treatment sequences. ie. single dose of 30 mg ferric maltol capsule in a fed condition single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition single dose of 30 mg ferric maltol capsule in a fasted condition single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04626414
Sponsor's protocol ID: ST10-01-104
Status last verified: Aug 2025
First submitted: 22 Oct 2020
Last updated: 24 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
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Not yet recruitingPhase 4
Iron Repletion in Cystic Fibrosis
Cystic Fibrosis, Iron Deficiencies
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia

All Anemia, Iron Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single Dose, Four-Way Crossover, Phase I Study to Compare the Pharmacokinetics of Ferric Maltol Capsules and Oral Suspension Under Fasted and Fed Conditions in Adult Healthy Volunteers
ClinicalTrials.gov ID: NCT04626414
Acronym / sponsor ID: ST10-01-104
Conditions: Anemia, Iron Deficiency
Keywords: iron deficiency, anaemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Shield TherapeuticsIndustry (pharma, biotech, devices)
Study start: 28 Sep 2020 (actual)
Primary completion: 13 Nov 2020 (actual)
Study completion: 13 Nov 2020 (actual)
First posted: 12 Nov 2020 (actual)
Results: Posted 24 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.

Detailed description

Open-label, Phase 1, four way crossover study to compare the PK of the new ferric maltol suspension, in healthy volunteers, with the existing ferric maltol capsules under fed and fasted conditions.

32 subjects will be randomised to 1:1:1:1 ratio to receive one of the treatment sequences.

Based on the randomised sequence, subjects will receive a single dose of 30mg ferric maltol capsule in a fed/ fasted condition and 30 mg (5ml) ferric maltol suspension in a fed/ fasted condition.

Subject participation in the study will consist of 3 periods:

Screening: up to 14 days
Randomised treatment: 8 days
Post-treatment follow up: 3-7 days following drug discontinuation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Subjects will be randomized 1:1:1:1 to one of the treatment sequences. ie. single dose of 30 mg ferric maltol capsule in a fed condition single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition single dose of 30 mg ferric maltol capsule in a fasted condition single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition

Arm	Type	Receives
30 mg ferric maltol capsule in a fed condition	Active comparator	Drug: Ferric maltol capsuleSingle dose of 30 mg ferric maltol capsule in a fed condition
30 mg ferric maltol capsule in a fasted condition	Active comparator	Drug: Ferric maltol capsuleSingle dose of 30 mg ferric maltol capsule in a fasted condition
30 mg (5 ml) ferric maltol suspension in a fed condition	Experimental	Drug: Ferric maltol suspensionSingle dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
30 mg (5 ml) ferric maltol suspension in a fasted condition	Experimental	Drug: Ferric maltol suspensionSingle dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Must voluntarily sign and date each Institutional Review Board (IRB)-approved informed consent form (ICF) prior to the initiation of any screening or study-specific procedures.
Willing and able to comply with study requirements.
Healthy adult subjects 18 to 55 years of age, inclusive at the time of informed consent.
Body Mass Index (BMI) of 18-32 kg/m2 inclusive
Female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. All female subjects must have a negative result for the pregnancy tests performed at screening and each treatment period.

Key exclusion criteria (17 listed)

A subject who meets any of the following criteria is not eligible for participation in the study.
Known hypersensitivity or allergy to the active substance or excipients of Ferric maltol oral suspension or capsules;
Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, as determined by the Investigator;
Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
Recent (within 6 months of screening) history of drug or alcohol abuse;

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
Ferric maltol capsuleAlso: ST10, Feraccru, Accrufersingle dose of 30 mg capsule	Drug	30 mg ferric maltol capsule in a fasted condition, 30 mg ferric maltol capsule in a fed condition
Ferric maltol suspensionAlso: ST10single dose of 30mg (5ml) oral suspension	Drug	30 mg (5 ml) ferric maltol suspension in a fasted condition, 30 mg (5 ml) ferric maltol suspension in a fed condition

Primary outcome

Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Capsule
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg ferric maltol capsule
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Capsule
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30 mg ferric maltol capsule
Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted vs Fed Condition in Ferric Maltol Suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose on both PK days
Ratio of maximum serum concentration (Cmax) of total iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension
Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Fasted vs. Fed Condition in Ferric Maltol Suspension
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in both PK days
Ratio of area under the curve (AUClast) of total serum iron in fasted vs fed condition in 30mg (5ml) ferric maltol suspension

22 secondary outcomes

PK Analysis of Total Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Baseline Corrected Serum Iron Concentration; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Baseline Corrected Serum Iron Concentration; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Baseline Corrected Serum Iron Concentration; AUCinf in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol Glucuronide; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol Glucuronide; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Maltol; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TSAT; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TSAT; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TIBC; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of TIBC; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Summary of Serious Adverse Events
Time frame: up to 2 weeks following last dose
PK Analysis of UIBC; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of UIBC; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1,1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Transferrin; Cmax in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
PK Analysis of Transferrin; AUClast in Fasted and Fed Conditions
Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose
Treatment-Emergent Adverse Events
Time frame: From first dose of ferric maltol on Day 1 to study completion
TEAE Leading to Premature Discontinuation of Study Drug/PK Assessments
Time frame: From first dose of ferric maltol on Day 1 to study completion
Vital Signs - Blood Pressure, Change From Day 1 to Day 8
Time frame: Screening to Day 8
Vital Signs - Heart Rate, Change From Day 1 to Day 7
Time frame: Screening to Day 7
Summary of Received Concomitant Medication by Formulation
Time frame: Day 1 to Day 8 (24 hrs post-dose of last dosing)

Results and safety

Results posted to the registry on 24 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ferric Maltol Sequence A	8	8
Ferric Maltol Sequence B	8	8
Ferric Maltol Sequence C	8	8
Ferric Maltol Sequence D	8	8

Primary outcome: Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition

Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition. Geometric least squares mean (90% Confidence Interval). Unit: ratio

Measure	Ferric Maltol Capsule and Ferric Maltol Suspension in a Fasted Condition n = 32
Value	69.94 (61.75 to 79.23)

Population analysed: Full Analysis Set Population

Primary outcome: Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Combined Periods of Fed Condition

Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition. Geometric least squares mean (90% Confidence Interval). Unit: ratio

Measure	Ferric Maltol Capsule Fed and Ferric Maltol Suspension Fed n = 32
Value	99.11 (87.50 to 112.27)

Population analysed: Full analysis set population

Primary outcome: Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fasted Condition

Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition. Geometric least squares mean (90% Confidence Interval). Unit: ratio

Measure	Ferric Maltol Capsule Fasted and Ferric Maltol Suspension Fasted n = 32
Value	77.54 (70.38 to 85.42)

Population analysed: FAS

Primary outcome: Ratio of Area Under the Curve (AUClast) of Total Serum Iron in Combined Period of Fed Condition

Time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition. Geometric least squares mean (90% Confidence Interval). Unit: ratio

Measure	Ferric Maltol Capsule Fed and Ferric Maltol Suspension Fed n = 32
Value	96.99 (88.04 to 106.86)

Population analysed: Full analysis set population

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
30 mg Ferric Maltol Capsule in a Fed Condition	0 of 32 (0%)	0 of 32 (0%)	0 of 32
30 mg Ferric Maltol Capsule in a Fasted Condition	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32
30 mg (5 ml) Ferric Maltol Suspension in a Fed Condition	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
30 mg (5 ml) Ferric Maltol Suspension in a Fasted Condition	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Jackie Mitchell, DPhil study director

Shield Therapeutics

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 Ferric maltol capsule and Ferric maltol suspension in people with Anemia, Iron Deficiency, run by Shield Therapeutics 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 12 inclusion and 17 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 24 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ratio of Maximum Serum Concentration (Cmax) of Total Iron in Fasted Condition (time frame: Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition). The study lists 8 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 NCT04626414.

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 24 Aug 2025.