Trial Outcomes & Findings for Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency (NCT NCT03181451)

Results Overview

Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

37 participants

Primary outcome timeframe

Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Results posted on

2021-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	30 mg Ferric Maltol 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	16.6 mg Ferric Maltol 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Overall Study STARTED	12	13	12
Overall Study COMPLETED	12	11	12
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	30 mg Ferric Maltol 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	16.6 mg Ferric Maltol 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	Total n=37 Participants Total of all reporting groups
Age, Continuous	14.1 years STANDARD_DEVIATION 1.56 • n=93 Participants	13.7 years STANDARD_DEVIATION 1.80 • n=4 Participants	14.2 years STANDARD_DEVIATION 2.12 • n=27 Participants	14.0 years STANDARD_DEVIATION 1.80 • n=483 Participants
Age, Customized 10-14	8 Participants n=93 Participants	7 Participants n=4 Participants	8 Participants n=27 Participants	23 Participants n=483 Participants
Age, Customized 15-17	4 Participants n=93 Participants	6 Participants n=4 Participants	4 Participants n=27 Participants	14 Participants n=483 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	8 Participants n=4 Participants	8 Participants n=27 Participants	24 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	13 Participants n=483 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	11 Participants n=93 Participants	13 Participants n=4 Participants	11 Participants n=27 Participants	35 Participants n=483 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Height	1.590 m STANDARD_DEVIATION 0.0641 • n=93 Participants	1.601 m STANDARD_DEVIATION 0.855 • n=4 Participants	1.618 m STANDARD_DEVIATION 0.0914 • n=27 Participants	1.603 m STANDARD_DEVIATION 0.0799 • n=483 Participants
Weight	57.83 kg STANDARD_DEVIATION 20.961 • n=93 Participants	62.77 kg STANDARD_DEVIATION 23.330 • n=4 Participants	52.07 kg STANDARD_DEVIATION 9.661 • n=27 Participants	57.41 kg STANDARD_DEVIATION 18.758 • n=483 Participants
BMI	22.695 kg/m^2 STANDARD_DEVIATION 7.4067 • n=93 Participants	24.265 kg/m^2 STANDARD_DEVIATION 7.7647 • n=4 Participants	19.760 kg/m^2 STANDARD_DEVIATION 2.7049 • n=27 Participants	22.182 kg/m^2 STANDARD_DEVIATION 6.4355 • n=483 Participants
Haemoglobin	12.27 g/dL STANDARD_DEVIATION 0.856 • n=93 Participants	12.75 g/dL STANDARD_DEVIATION 1.067 • n=4 Participants	12.37 g/dL STANDARD_DEVIATION 1.418 • n=27 Participants	12.47 g/dL STANDARD_DEVIATION 1.124 • n=483 Participants
Ferritin	16.2 μg/L STANDARD_DEVIATION 7.18 • n=93 Participants	18.8 μg/L STANDARD_DEVIATION 8.29 • n=4 Participants	13.8 μg/L STANDARD_DEVIATION 8.34 • n=27 Participants	16.3 μg/L STANDARD_DEVIATION 8.02 • n=483 Participants

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 1	1.1632 mg/L Standard Deviation 0.18435	0.5299 mg/L Standard Deviation 0.02245	2.4518 mg/L Standard Deviation 1.29590

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 10	2.1028 mg/L Standard Deviation 0.13342	0.9926 mg/L Standard Deviation 0.02349	4.2355 mg/L Standard Deviation 0.78110

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics and population PK analysis of maltol glucuronide AUC from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Area Under The Curve [AUC] of Maltol Glucuronide on Day 1	5.613 h*mg/L Standard Deviation 0.7589	2.585 h*mg/L Standard Deviation 0.0968	11.090 h*mg/L Standard Deviation 3.9033

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Area Under The Curve [AUC] of Maltol Glucuronide on Day 10	10.518 h*mg/L Standard Deviation 0.5277	5.016 h*mg/L Standard Deviation 0.1133	20.511 h*mg/L Standard Deviation 1.7997

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics and population PK analysis of maltol glucuronide Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Average Plasma Concentration [Cave(0-6h)] of Maltol Glucuronide on Day 10	1.7531 mg/L Standard Deviation 0.08795	0.8360 mg/L Standard Deviation 0.01889	3.4186 mg/L Standard Deviation 0.29995

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Time of Maximum Plasma Concentration [Tmax] of Maltol Glucuronide on Day 1	1.00 h Interval 0.75 to 1.0	1.00 h Interval 1.0 to 1.0	1.00 h Interval 0.75 to 1.0

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Time of Maximum Plasma Concentration [Tmax] of Maltol Glucuronide on Day 10	0.75 h Interval 0.75 to 0.75	0.75 h Interval 0.75 to 0.75	0.75 h Interval 0.75 to 0.75

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics and population PK analysis of maltol glucuronide t1/2 from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Half Life [t1/2] of Maltol Glucuronide on Day 1	10.447 h Standard Deviation 1.8503	10.806 h Standard Deviation 0.4707	11.384 h Standard Deviation 5.4738

PRIMARY outcome

Timeframe: Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Descriptive statistics of ratio maltol glucuronide Cmax Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Ratio of Maximum Plasma Concentration [Cmax] of Maltol Glucuronide on Day 10/Day 1	1.836 ratio Standard Deviation 0.2109	1.875 ratio Standard Deviation 0.0537	1.956 ratio Standard Deviation 0.6210

PRIMARY outcome

Timeframe: Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics of ratio maltol glucuronide AUC Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Ratio of Area Under The Curve [AUC] of Maltol Glucuronide on Day 10/Day 1	1.899 ratio Standard Deviation 0.2286	1.942 ratio Standard Deviation 0.0582	2.030 ratio Standard Deviation 0.6695

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of iron Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Average Serum Concentration [Cave(0-6h)] of Iron on Day 10	0.9557 mg/L Standard Deviation 0.29645	0.9748 mg/L Standard Deviation 0.39783	1.1667 mg/L Standard Deviation 0.61420

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of change in serum iron \[Ctrough to Cmax\] from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Change From Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in Serum Iron on Day 1	0.4102 mg/L Standard Deviation 0.22144	0.21715 mg/L Standard Deviation 0.11873	0.6159 mg/L Standard Deviation 0.32320

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of change in serum iron \[Ctrough to Cmax\] from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Change From Pre-Dose (Ctrough) to Maximum Post-Dose (Cmax) in Serum Iron on Day 10	0.3625 mg/L Standard Deviation 0.15333	0.2251 mg/L Standard Deviation 0.08362	0.5486 mg/L Standard Deviation 0.32367

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Serum Iron on Day 1	5.963 h*mg/L Standard Deviation 1.7793	3.928 h*mg/L Standard Deviation 1.1318	6.711 h*mg/L Standard Deviation 2.5721

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Serum Iron on Day 10	5.734 h*mg/L Standard Deviation 1.7787	5.849 h*mg/L Standard Deviation 2.3870	7.000 h*mg/L Standard Deviation 3.6852

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Transferrin Saturation (TSAT) on Day 1	159.21 h*% Standard Deviation 50.723	104.50 h*% Standard Deviation 41.009	179.47 h*% Standard Deviation 60.259

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Pre-dose Adjusted Incremental Area Under the Curve [AUC(0-6h)] of Transferrin Saturation (TSAT) on Day 10	149.40 h*% Standard Deviation 37.799	157.43 h*% Standard Deviation 81.693	180.14 h*% Standard Deviation 76.193

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 1

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Apparent Systemic Clearance (CL/F) of Iron on Day 1	0.654 L/h Standard Deviation 0.2441	0.324 L/h Standard Deviation 0.1517	1.321 L/h Standard Deviation 0.6945

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 10

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Apparent Systemic Clearance (CL/F) of Iron on Day 10	1.757 L/h Standard Deviation 0.6673	0.808 L/h Standard Deviation 0.3089	3.264 L/h Standard Deviation 2.2297

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Descriptive statistics and population PK analysis of iron V/F from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Apparent Volume of Distribution (V/F) of Iron on Day 1	14.244 L Standard Deviation 4.8083	10.462 L Standard Deviation 3.1033	22.114 L Standard Deviation 7.2315

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: As PPD analysis was performed, the V/F could not be estimated.

Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 1

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: As PPD analysis was performed, the V/F could not be estimated.

Descriptive statistics and population PK analysis of TSAT V/F from PK samples collected on Day 10

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 to Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Ratio AUC0-6h measured after last dose of Ferric Maltol on Day 10 vs first dose Day 1.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Ratio Auc(0-6) Maltol Glucuronide Day 10/Day 1	1.899 Ratio Standard Deviation 0.2286	2.030 Ratio Standard Deviation 0.6695	1.942 Ratio Standard Deviation 0.0582

PRIMARY outcome

Timeframe: Measured after first and last dose of Ferric Maltol on Day 1 & Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Serum Iron - RAUC(0-6h) Day 10/Day 1

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Serum Iron - RAUC(0-6h) D10/D1	1.020 Ratio Standard Deviation 0.3170	1.038 Ratio Standard Deviation 0.3973	1.529 Ratio Standard Deviation 1.4673

PRIMARY outcome

Timeframe: Measured after first dose of Ferric Maltol on Day 1 (0h)

Population: ITT

Transferrin Saturation (TSAT%) Day 1, baseline

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Transferrin Saturation (%) Day 1, Baseline	16.8 percentage saturation Standard Deviation 9.25	15.8 percentage saturation Standard Deviation 9.31	11.5 percentage saturation Standard Deviation 5.66

PRIMARY outcome

Timeframe: Measured after first dose of Ferric Maltol on Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Transferrin Saturation (TSAT%) Day 1, maximum response (%)

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Transferrin Saturation (%) Day 1, Maximum Response (%)	28.261 percentage saturation Standard Deviation 8.4784	32.845 percentage saturation Standard Deviation 10.5913	18.68 percentage saturation Standard Deviation 7.13

PRIMARY outcome

Timeframe: Measured after first dose of Ferric Maltol on Day 1. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Transferrin Saturation Day 1, Time to Maximum Response Tmax	3.00 hour Interval 2.0 to 4.0	3.00 hour Interval 3.0 to 5.0	4.00 hour Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Transferrin Saturation (TSAT%) Day 10, maximum response (%). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Transferrin Saturation (%) Day 10, Maximum Response (%)	27.214 percentage saturation Standard Deviation 6.699	33.524 percentage saturation Standard Deviation 13.633	27.779 percentage saturation Standard Deviation 13.863

PRIMARY outcome

Timeframe: Measured after first dose of Ferric Maltol on Day 10. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h).

Population: ITT

Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Transferrin Saturation Day 10, Time to Maximum Response Tmax	3.00 hour Interval 0.0 to 4.0	3.00 hour Interval 0.0 to 4.0	3.00 hour Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: Measured after first dose of Ferric Maltol on Day 1 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

AUC0-inf for Maltol Glucuronide from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
AUC0-inf Day 1 for Maltol Glucuronide	17.862 h.mg/L Standard Deviation 0.9328	34.372 h.mg/L Standard Deviation 4.5052	8.590 h.mg/L Standard Deviation 0.2025

PRIMARY outcome

Timeframe: Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

AUC0-tau for Maltol Glucuronide from PK samples collected on Day 10. Area under the plasma concentration versus time curve from time 0 to tau.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
AUC0-tau Day 10 for Maltol Glucuronide	17.862 h mg/L Standard Deviation 0.9327	34.368 h mg/L Standard Deviation 4.4981	8.59 h mg/L Standard Deviation 0.2024

PRIMARY outcome

Timeframe: Day 10 pre-dose to last (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT.

Change from pre-dose to last PK samples collected on Day 10 for maltol glucuronide.Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Cthrough for Maltol Glucuronide Day 10	0.9762 mg/L Standard Deviation 0.10586	1.8496 mg/L Standard Deviation 0.67761	0.4804 mg/L Standard Deviation 0.01639

PRIMARY outcome

Timeframe: Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Maximum serum concentration of serum iron on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Serum Iron Cmax Day 1	1.681 mg/L Standard Deviation 0.30405	1.2328 mg/L Standard Deviation 0.47471	0.7030 mg/L Standard Deviation 0.19765

PRIMARY outcome

Timeframe: Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Maximum serum concentration of serum iron on Day 10.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Serum Iron Cmax on Day 10	1.0462 mg/L Standard Deviation 0.3221	1.3034 mg/L Standard Deviation 0.6741	1.0338 mg/L Standard Deviation 0.4023

PRIMARY outcome

Timeframe: Day 10 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: ITT

Minimum concentration between dose time and dose time+TAU

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Plasma Maltol Glucuronide Cthrough D10/Day1	0.9762 mg/L Standard Deviation 0.105	1.8496 mg/L Standard Deviation 0.677	0.4804 mg/L Standard Deviation 0.0163

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h

Population: As PPD analysis was performed the CL/F could not be estimated.

Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 1

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)

Population: As PPD analysis was performed, the V/F could not be estimated.

Descriptive statistics and population PK analysis of serum TSAT CL/F from PK samples collected on Day 10

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h

Population: The dose of maltol glucuronide was not calculable using non-compartmental analysis.

Descriptive statistics and population PK analysis of plasma maltol glucuronide CL/F from PK samples collected on Day 1.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h

Population: The dose of maltol glucuronide was not calculable using non-compartmental analysis.

Descriptive statistics and population PK analysis of plasma maltol glucuronide CL/F from PK samples collected on Day 10.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 pre-dose to Day 10 pre-dose (0h on each day)

Population: ITT. Only subjects who had baseline samples taken on each PK day.

Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Transferrin - Change From Baseline to Day 10, Predose	-0.147 g/L Standard Deviation 0.1419	0.032 g/L Standard Deviation 0.2275	-0.085 g/L Standard Deviation 0.1510

SECONDARY outcome

Timeframe: Pre-dose on Day 1 to Day 10 (0h)

Population: ITT. Only subjects who had baseline samples taken on each PK day.

Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose.

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Ferritin - Change From Baseline to Day 10, Predose	4.1 μg/L Standard Deviation 3.73	0.5 μg/L Standard Deviation 4.95	7.3 μg/L Standard Deviation 8.22

SECONDARY outcome

Timeframe: Predose from Day 1 to Day 10 (0h on each day)

Population: ITT. Only subjects who had baseline samples taken on each PK day.

Change calculated as difference in values measured at Day 1, predose and on Day 10, predose

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Total Iron Binding Capacity - Change From Day 1 to Day 10, Predose	-3.11 umol/L Standard Deviation 3.201	1.13 umol/L Standard Deviation 4.452	-2.12 umol/L Standard Deviation 3.406

SECONDARY outcome

Timeframe: Pre-dose on Day 1 to Day 10 (0h each day)

Population: ITT

Change calculated as difference in values measured at Day 1, predose and on Day 10, predose

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=11 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
UIBC - Change From Day 1 to Day 10, Predose	-2.33 umol/L Standard Deviation 5.525	-4.49 umol/L Standard Deviation 8.343	-2.10 umol/L Standard Deviation 7.775

SECONDARY outcome

Timeframe: Day 1 (0h)

Population: ITT

Negative and Positive Non-Transferrin Bound Iron \[NTBI\] tests on Day 1, predose

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Negative and Positive NTBI Tests on Day 1 Positive	0 Participants	0 Participants	0 Participants
Negative and Positive NTBI Tests on Day 1 Negative	13 Participants	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Screening and Day 10 (1-4 hours post-dose)

Population: Safety population

Change calculated as difference in values measured at Screening (Baseline) and on Day 10

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=11 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Change From Baseline to Day 10 in Haemoglobin Concentration	-0.33 g/dL Standard Deviation 1.097	-0.45 g/dL Standard Deviation 0.301	-0.03 g/dL Standard Deviation 0.789

SECONDARY outcome

Timeframe: Change calculated as difference in values measured at Screening (Baseline) and on Day 10.

Population: ITT. Only subjects who had baseline samples and Day 10 samples taken.

Change from Baseline to Day 10 in Absolute Reticulocyte Count collected from PK samples

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=10 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=5 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=5 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Change From Baseline to Day 10 in Absolute Reticulocyte Count	-0.001 cells*10^12/L Standard Deviation 0.0218	0.016 cells*10^12/L Standard Deviation 0.0358	0.036 cells*10^12/L Standard Deviation 0.0114

SECONDARY outcome

Timeframe: From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks

Population: screened population

Descriptive summary of incidence and causal 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)

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Treatment-emergent Adverse Events (AEs) Leading to Premature Discontinuation of Study Drug/PK Assessments	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening and Day 10 (1-4 hours post-dose)

Population: Safety population. Subjects who had ECG performed at both visits.

Overall clinical interpretation of routine ECG parameters from Screening to Day 10

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=10 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Changes in 12-lead ECG Parameters From Screening to Day 10 Normal	11 Participants	12 Participants	10 Participants
Changes in 12-lead ECG Parameters From Screening to Day 10 Abnormal	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening, Day 1, Day 10 and Post-Study Follow-up visit, on average 4 weeks

Population: Safety population

Number of subjects with concomitant medications Taken by \>5% of Subjects

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Concomitant Medications	13 Participants	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 10

Population: ITT

Negative and Positive Non-Transferrin Bound Iron \[NTBI\] tests on Day 10, predose

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=11 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=10 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Negative and Positive NTBI Tests on Day 10, Predose Positive	0 Participants	0 Participants	1 Participants
Negative and Positive NTBI Tests on Day 10, Predose Negative	11 Participants	10 Participants	11 Participants

SECONDARY outcome

Timeframe: From first dose of ferric maltol Day 1 through study completions, on average 4 weeks

Population: Safety population

Descriptive summary of TESAE according to MedDRA preferred Term

Outcome measures

Outcome measures
Measure	16.6 mg Ferric Maltol n=13 Participants 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	30 mg Ferric Maltol n=12 Participants 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 Participants 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Treatment-emergent Serious Adverse Event (TESAE)	0 Participants	0 Participants	0 Participants

Adverse Events

30 mg Ferric Maltol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

16.6 mg Ferric Maltol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

7.8 mg Ferric Maltol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	30 mg Ferric Maltol n=12 participants at risk 12 subjects will receive 30 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 30 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	16.6 mg Ferric Maltol n=13 participants at risk 13 subjects will receive 16.6 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 16.6 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.	7.8 mg Ferric Maltol n=12 participants at risk 12 subjects will receive 7.8 mg Ferric Maltol twice daily for 9 days (Days 1-9) plus a final 7.8 mg dose on the morning of Day 10. PK study Day 1 \& Day 10. Ferric Maltol: To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
Cardiac disorders Palpitations	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Gastrointestinal disorders Faeces discoloured	25.0% 3/12 • 10 days	7.7% 1/13 • 10 days	8.3% 1/12 • 10 days
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	16.7% 2/12 • 10 days
Gastrointestinal disorders Nausea	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Gastrointestinal disorders Vomiting	0.00% 0/12 • 10 days	7.7% 1/13 • 10 days	8.3% 1/12 • 10 days
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Gastrointestinal disorders Anal incontinence	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Gastrointestinal disorders Constipation	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Gastrointestinal disorders Lip dry	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
General disorders Fatigue	16.7% 2/12 • 10 days	7.7% 1/13 • 10 days	8.3% 1/12 • 10 days
General disorders Injection site pain	0.00% 0/12 • 10 days	7.7% 1/13 • 10 days	0.00% 0/12 • 10 days
General disorders Pyrexia	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Infections and infestations Cellulitis	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Infections and infestations Nasopharyngitis	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Infections and infestations Tonsillitis	0.00% 0/12 • 10 days	7.7% 1/13 • 10 days	0.00% 0/12 • 10 days
Injury, poisoning and procedural complications Ligament sprain	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/12 • 10 days	7.7% 1/13 • 10 days	0.00% 0/12 • 10 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nevus haemorrhage	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Nervous system disorders Headache	33.3% 4/12 • 10 days	15.4% 2/13 • 10 days	8.3% 1/12 • 10 days
Nervous system disorders Dizziness	16.7% 2/12 • 10 days	7.7% 1/13 • 10 days	0.00% 0/12 • 10 days
Nervous system disorders Lethargy	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Skin and subcutaneous tissue disorders Granuloma skin	0.00% 0/12 • 10 days	0.00% 0/13 • 10 days	8.3% 1/12 • 10 days
Skin and subcutaneous tissue disorders Papule	8.3% 1/12 • 10 days	0.00% 0/13 • 10 days	0.00% 0/12 • 10 days

Additional Information

Jackie Mitchell MA DPhil

Shield Therapeutics

Phone: +44 (0) 191 511 8515

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place