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

NCT04626414 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ST10-01-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia, Iron Deficiency

Keywords

iron deficiency, anaemia

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose

Study Arms (4)

30 mg ferric maltol capsule in a fed condition

ACTIVE COMPARATOR

Single dose of 30 mg ferric maltol capsule in a fed condition

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

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

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

Drug: Ferric maltol suspension

Interventions

Ferric maltol capsule DRUG

single dose of 30 mg capsule

Also known as: ST10, Feraccru, Accrufer

30 mg ferric maltol capsule in a fasted condition; 30 mg ferric maltol capsule in a fed condition

Ferric maltol suspension DRUG

single dose of 30mg (5ml) oral suspension

Also known as: ST10

30 mg (5 ml) ferric maltol suspension in a fasted condition; 30 mg (5 ml) ferric maltol suspension in a fed condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shield Therapeutics: lead

Study Sites (1)

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric maltol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jackie Mitchell
• Organization: Shield Therapeutics

jackie.mitchell@shieldtx.com

+44 (0) 191 511 8500

Study Officials

• Jackie Mitchell, DPhil

  Shield Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 12, 2020
• Study Start: September 28, 2020
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)