- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04626414
Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jackie Mitchell, DPhil
- Phone Number: 44 (0) 191 511 8515
- Email: jmitchell@shieldtx.com
Study Contact Backup
- Name: Roberta Vasari
- Phone Number: +44 (0) 207 186 8525
- Email: rvasari@shieldtx.com
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45227
- Recruiting
- Medpace Clinical Pharmacology Unit
-
Contact:
- Leela Vrishabhendra, MD
- Phone Number: 513-366-3220
- Email: L.Vrishabhendra@Medpace.com
-
Contact:
- Dismas Meyers
- Email: D.Meyers@Medpace.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 30 mg ferric maltol capsule in a fed condition
Single dose of 30 mg ferric maltol capsule in a fed condition
|
single dose of 30 mg capsule
Other Names:
|
ACTIVE_COMPARATOR: 30 mg ferric maltol capsule in a fasted condition
Single dose of 30 mg ferric maltol capsule in a fasted condition
|
single dose of 30 mg capsule
Other Names:
|
EXPERIMENTAL: 30 mg (5 ml) ferric maltol suspension in a fed condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fed condition
|
single dose of 30mg (5ml) oral suspension
Other Names:
|
EXPERIMENTAL: 30 mg (5 ml) ferric maltol suspension in a fasted condition
Single dose of 30 mg (5 ml) ferric maltol suspension in a fasted condition
|
single dose of 30mg (5ml) oral suspension
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio of maximum serum concentration (Cmax) of total iron in fasted condition
Time Frame: Pre-dose and 0.15, 0.30, 0.45, 1, 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.
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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
Time Frame: Pre-dose and 0.15, 0.30, 0.45, 1, 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
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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
Time Frame: Pre-dose and 0.15, 0.30, 0.45, 1, 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
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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
Time Frame: Pre-dose and 0.15, 0.30, 0.45, 1, 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
|
Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose
|
PK analysis of maltol; AUClastin fasted and fed conditions
Time Frame: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Summary of Serious Adverse Events
Time Frame: up to 2 weeks following last dose
|
Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted)
|
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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 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, 2, 3, 4, 6, 10 and 24 hours post-dose
|
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)
|
Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose
|
Changes in Hb from screening to Day 8
Time Frame: Screening to Day 8
|
Changes in Haemoglobin; change calculated as difference in values measured at Screening, predose and on Day 8, pre-dose by formulation (suspension or capsule) and condition (fed or fasted)
|
Screening to Day 8
|
Treatment-Emergent Adverse Events
Time Frame: From first dose of ferric maltol on Day 1 to study completion
|
Descriptive summary of incidence and casual relationship of treatment-emergent serious adverse events according to MedDRA preferred term (PT) and system organ class (SOC)
|
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
|
Descriptive summary of incidence and casual relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC)
|
From first dose of ferric maltol on Day 1 to study completion
|
Vital signs - blood pressure, change from Day 1 to Day 8, Pre-dose
Time Frame: Screening to Day 8
|
Descriptive statistics for changes in blood pressure from Screening to Day 8
|
Screening to Day 8
|
Vital signs - heart rate, change from Day 1 to Day 8, Pre-dose
Time Frame: Screening to Day 8
|
Descriptive statistics for changes in heart rate from Screening to Day 8
|
Screening to Day 8
|
Summary of concomitant medication by formulation
Time Frame: Day 1 to Day 8 (24 hrs post-dose of last dosing)
|
Number of concomitant medications by formulation (suspension or capsule)
|
Day 1 to Day 8 (24 hrs post-dose of last dosing)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jackie Mitchell, DPhil, Shield Therapeutics
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ST10-01-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Anemia, Iron Deficiency
-
Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
-
Luzerner KantonsspitalRecruitingIron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron DeficienciesSwitzerland
-
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
-
Children's Hospital Los AngelesWithdrawnAnemia | Iron-deficiency Anemia | Healthy ControlsUnited States
-
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
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
Clinical Trials on Ferric maltol capsule
-
Shield TherapeuticsCompletedCrohn's Disease | Inflammatory Bowel Disease | Iron Deficiency Anaemia
-
Hannover Medical SchoolShields, Shields and AssociatesTerminatedHypertension, Pulmonary | Anemia, Iron DeficiencyGermany
-
Shield TherapeuticsCompletedAnemia, Iron-Deficiency | Crohn's Disease | Inflammatory Bowel DiseaseUnited States, France, Germany, Spain, Belgium, Hungary
-
Hannover Medical SchoolShields, Shields and AssociatesTerminatedAnemia, Iron Deficiency | Heart Failure, Left SidedGermany
-
The Royal Wolverhampton Hospitals NHS TrustNorgineRecruiting
-
Shield TherapeuticsMedpace, Inc.CompletedIron Deficiency, Anaemia in Children | Iron-DeficiencyUnited Kingdom
-
Hannover Medical SchoolNorgineRecruitingAnemia, Iron Deficiency | Heart Failure, Left-sidedGermany
-
Shield TherapeuticsRecruitingIron-deficiency | AnemiaUnited States, United Kingdom, Puerto Rico
-
Shield TherapeuticsCompletedRenal Insufficiency, Chronic | Iron-Deficiency AnemiaUnited States
-
Shield TherapeuticsCompletedUlcerative Colitis | Inflammatory Bowel Disease | Iron Deficiency Anaemia