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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg ferric maltol capsule in a fed condition | Active Comparator | Single dose of 30 mg ferric maltol capsule in a fed condition |
|
| 30 mg ferric maltol capsule in a fasted condition | Active Comparator | Single dose of 30 mg ferric maltol capsule in a fasted condition |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric maltol capsule | Drug | single dose of 30 mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jackie Mitchell, DPhil | Shield Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology Unit | Cincinnati | Ohio | 45227 | United States |
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32 subjects recruited. 8 subjects randomised to each sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Maltol Sequence A | Period 1 capsule-fed; Period 2 suspension-fed; Period 3 capsule-fasted; Period 4 suspension-fasted. |
| FG001 | Ferric Maltol Sequence B | Period 1 suspension-fasted; Period 2 capsule-fed; Period 3 suspension-fed; Period 4 capsule-fasted. |
| FG002 | Ferric Maltol Sequence C | Period 1 capsule-fasted; Period 2 suspension-fasted; Period 3 capsule-fed; Period 4 suspension-fed. |
| FG003 | Ferric Maltol Sequence D | Period 1 suspension-fed; Period 2 capsule-fasted; Period 3 suspension-fasted; Period 4 capsule-fed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overall demographic and baseline characteristics of the randomised population. The Randomized population is defined as all subjects who are randomized. The FAS is defined as all subjects who have had at least one dose of study drug and who have at least one evaluable post-dose PK sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Maltol Sequence A | Period 1 capsule-fed; Period 2 suspension fed; Period 3 capsule fasted; Period 4 suspension fasted. |
| BG001 | Ferric Maltol Sequence B | Period 1 suspension fasted; Period 2 capsule-fed; Period 3 suspension fed; Period 4 capsule fasted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set Population | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
|
8 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30 mg Ferric Maltol Capsule in a Fed Condition | Single dose of 30 mg ferric maltol capsule in a fed condition |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site pain | General disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jackie Mitchell | Shield Therapeutics | +44 (0) 191 511 8500 | jackie.mitchell@shieldtx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2020 | Aug 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2020 | Aug 23, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C062088 | ferric maltol |
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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
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|
| Ferric maltol suspension | Drug | single dose of 30mg (5ml) oral suspension |
|
|
| 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 |
| 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) |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | Screening to Day 7 |
| Summary of Received Concomitant Medication by Formulation | Number of participants having received concomitant medications by formulation (suspension or capsule) | Day 1 to Day 8 (24 hrs post-dose of last dosing) |
| BG002 | Ferric Maltol Sequence C | Period 1 capsule fasted; Period 2 suspension fasted; Period 3 capsule fed; Period 4 suspension fed. |
| BG003 | Ferric Maltol Sequence D | Period 1 suspension fed; Period 2 capsule fasted; Period 3 suspension fasted; Period 4 capsule fed. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Full analysis set population | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
|
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| Primary | 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 | FAS | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
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| Primary | 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 | Full analysis set population | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
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| Primary | 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 | Full Analysis Set Population | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
|
|
| Primary | 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 | FAS | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
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| Primary | 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 | FAS | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
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| Primary | 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 | FAS | Posted | Geometric Least Squares Mean | 90% Confidence Interval | ratio | 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 |
|
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| Secondary | 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) | FAS - If the Lambda z was not assigned, the values of associated PK parameters AUCinf was not calculated | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS. If the Lambda z was not assigned, the values of associated PK parameters AUCinf was not calculated. | Posted | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS - If the Lambda z was not assigned, the values of associated PK parameters AUC last was not calculated. | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | Summary of Serious Adverse Events | Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted) | Safety population | Posted | Count of Participants | Participants | up to 2 weeks following last dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1,1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
|
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | 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) | FAS | Posted | Mean | Standard Deviation | h*ng/mL | Pre-dose and 0.15, 0.30, 0.45, 1, 1.5, 2, 3, 4, 6, 10 and 24 hours post-dose |
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| Secondary | Treatment-Emergent Adverse Events | Treatment-Emergent Adverse Events from Day 1 to Day 22 (Study completion) | Safety population | Posted | Count of Participants | Participants | From first dose of ferric maltol on Day 1 to study completion |
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| Secondary | 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 | Safety population | Posted | Count of Participants | Participants | From first dose of ferric maltol on Day 1 to study completion |
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| Secondary | Vital Signs - Blood Pressure, Change From Day 1 to Day 8 | Descriptive statistics for changes in blood pressure from Screening to Day 8 | Safety population | Posted | Mean | Standard Deviation | mmHg | Screening to Day 8 |
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| Secondary | Vital Signs - Heart Rate, Change From Day 1 to Day 7 | Descriptive statistics for changes in heart rate from Screening to Day 7 | Safety population | Posted | Mean | Standard Deviation | beats/min | Screening to Day 7 |
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| Secondary | Summary of Received Concomitant Medication by Formulation | Number of participants having received concomitant medications by formulation (suspension or capsule) | Safety population | Posted | Number | participants | Day 1 to Day 8 (24 hrs post-dose of last dosing) |
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|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 30 mg Ferric Maltol Capsule in a Fasted Condition | Single dose of 30 mg ferric maltol capsule in a fasted condition | 0 | 32 | 0 | 32 | 2 | 32 |
| EG002 | 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 | 0 | 32 | 0 | 32 | 3 | 32 |
| EG003 | 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 | 0 | 32 | 0 | 32 | 3 | 32 |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Systolic blood pressure |
|