Trial Outcomes & Findings for Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers (NCT NCT02636049)

Last Updated: 2019-08-20

Results Overview

Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and Day 3 (35 microgram/kg IV dose of Triferic given over 30 - 60 seconds) in order to determine the Peak Serum Concentration, corrected (Cmax) of total serum iron.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

16 hours

Results posted on

2019-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants After enrollment, all subjects underwent blood sampling for pharmacokinetic (PK) purposes over 16 hours on Day 1 to establish a baseline. On Day 2, subjects received a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours, with blood sampling for PK purposes over 16 hours. On Day 3, subject received Triferic 35 micrograms/kg as an intravenous push (administered in 30 - 60 seconds), with blood sampling for PK purposes over 16 hours. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Overall Study STARTED	12
Overall Study Triferic 6 mg IV Over 3 Hours	12
Overall Study Triferic 35 Micrograms/kg IV Push	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Population n=12 Participants All 12 participants completed every arm of the study. Therefore, the baseline demographic characteristics of the Safety Population as a whole also reflect the characteristics of each arm of the study.
Age, Continuous	38.4 years STANDARD_DEVIATION 8.99 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Height	179.61 centimeters STANDARD_DEVIATION 7.365 • n=5 Participants
Weight	84.48 kilogram STANDARD_DEVIATION 12.892 • n=5 Participants
Body Mass Index	26.07 Kilogram/square meter STANDARD_DEVIATION 2.592 • n=5 Participants

PRIMARY outcome

Timeframe: 16 hours

Population: Pharmacokinetic population: all enrolled subjects who received at least 1 dose of study drug and had sufficient pharmacokinetic samples (a sample at the end of infusion and at least 3 samples during the elimination phase) for analysis.

Outcome measures

Outcome measures
Measure	Treatment Period: 6 mg Triferic IV Over 3 Hours n=11 Participants Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.	Treatment Period: 35 Micrograms/kg IV Push n=12 Participants Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Maximum Drug Concentration (Cmax) of Total Serum Iron	102 microgram/deciliter Geometric Coefficient of Variation 40.1	44.1 microgram/deciliter Geometric Coefficient of Variation 71.9

PRIMARY outcome

Timeframe: 16 hours

Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and study day 3 (35 microgram/kg IV Triferic dose administered in 30 - 60 seconds) in order to determine the AUC(last) of total serum iron.

Outcome measures

Outcome measures
Measure	Treatment Period: 6 mg Triferic IV Over 3 Hours n=11 Participants Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.	Treatment Period: 35 Micrograms/kg IV Push n=12 Participants Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Area Under the Serum Iron Concentration Time Curve From Time Zero to the Time of Last Quantified Concentration (AUC(Last)) of Total Serum Iron	858 hour*microgram/deciliter Geometric Coefficient of Variation 59.6	175 hour*microgram/deciliter Geometric Coefficient of Variation 234

SECONDARY outcome

Timeframe: 10 - 14 days

Population: Safety Population: all enrolled subjects

The number of patients that experienced treatment emergent adverse events will be quantified.

Outcome measures

Outcome measures
Measure	Treatment Period: 6 mg Triferic IV Over 3 Hours n=12 Participants Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.	Treatment Period: 35 Micrograms/kg IV Push n=12 Participants Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Incidence of Treatment Emergent Adverse Events	1 participants	1 participants

SECONDARY outcome

Timeframe: 10 - 14 days

Population: Safety Population: all enrolled subjects

The number of patients that experienced treatment emergent serious adverse events (TESEAs) will be quantified.

Outcome measures

Outcome measures
Measure	Treatment Period: 6 mg Triferic IV Over 3 Hours n=12 Participants Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.	Treatment Period: 35 Micrograms/kg IV Push n=12 Participants Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Incidence of Treatment Emergent Serious Adverse Events	0 participants	0 participants

Adverse Events

Treatment Period: 6 mg Triferic IV Over 3 Hours

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treatment Period: 35 Micrograms/kg IV Push

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Period: 6 mg Triferic IV Over 3 Hours n=12 participants at risk Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.	Treatment Period: 35 Micrograms/kg IV Push n=12 participants at risk Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL. Triferic: Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Infections and infestations Viral Upper Respiratory Tract Infection	8.3% 1/12 • Number of events 1	0.00% 0/12
General disorders Infusion Site Swelling	0.00% 0/12	8.3% 1/12 • Number of events 1

Additional Information

Clinical Project Manager

Rockwell Medical, Inc

Phone: 248-960-9009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60