Trial Outcomes & Findings for Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers (NCT NCT02767128)

Last Updated: 2019-02-01

Results Overview

The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

0, 1, 2, 4, 6, 8, 12, 16, and 24 hours

Results posted on

2019-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants This is a cross-over pharmacokinetic (PK) study where all participants underwent baseline blood sampling over 24 hours for PK purposes followed by five different oral treatments in a randomized sequence: Fer-In-Sol 3 mg Fe/kg, Shohl's solution 0.7 mL/kg followed 10 minutes later by Fer-In-Sol 3 mg Fe/kg, Triferic 3 mg Fe/kg, Shohl's solution 0.7 mL/kg followed 10 minutes later by Triferic 3 mg Fe/kg, and Shohl's solution 0.7 mL/kg followed immediately by Triferic 3 mg Fe/kg. 24 blood sampling for PK purposes took place at each randomized treatment visit. Once the randomized sequence was completed, all subjects were administered 6.6 mg Triferic intravenously at the last treatment visit, with blood sampling for PK purposes over 24 hours.
Overall Study STARTED	14
Overall Study Baseline	14
Overall Study Fer-In-Sol	14
Overall Study Shohl's + Fer-In-Sol	14
Overall Study Triferic	14
Overall Study Shohl's + Triferic After 10 Min	14
Overall Study Shohl's + Triferic Immediately	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Population n=14 Participants All 14 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	39.1 years STANDARD_DEVIATION 11.99 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	14 participants n=93 Participants
Body Mass Index	24.5 Kilogram/square meter STANDARD_DEVIATION 3.93 • n=93 Participants

PRIMARY outcome

Timeframe: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours

Population: 14 patients completed all six treatments. While all participants had adequate blood samples collected to be included in pharmacokinetic analysis, some samples were below the quantifiable limit (BLQ) of the bioanalytical assay, which was 50 micrograms/deciliter. Therefore, number of participants analyzed for each treatment does not equal 14.

Outcome measures

Outcome measures
Measure	Treatment A n=14 Participants Patients will receive a single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).	Treatment B n=13 Participants Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw.	Treatment C n=7 Participants Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.	Treatment D n=11 Participants Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.	Treatment E n=10 Participants Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.	Treatment F n=13 Participants Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours.
Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax	140 microgram/deciliter Geometric Coefficient of Variation 39.4	62.0 microgram/deciliter Geometric Coefficient of Variation 78.7	32.4 microgram/deciliter Geometric Coefficient of Variation 93.9	51.9 microgram/deciliter Geometric Coefficient of Variation 82.2	52.0 microgram/deciliter Geometric Coefficient of Variation 71.8	100 microgram/deciliter Geometric Coefficient of Variation 91.5

SECONDARY outcome

Timeframe: 13 days

Population: Safety Population: all enrolled subjects who received at least one dose of study drug.

The number of participants in each treatment group who experienced treatment emergent adverse events will be quantified.

Outcome measures

Outcome measures
Measure	Treatment A n=14 Participants Patients will receive a single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).	Treatment B n=14 Participants Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw.	Treatment C n=14 Participants Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.	Treatment D n=14 Participants Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.	Treatment E n=14 Participants Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.	Treatment F n=14 Participants Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	7 Participants	5 Participants	2 Participants	6 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 13 days

Population: Safety Population: all enrolled subjects who received at least one dose of study drug.

The number of participants in each treatment group who experienced treatment emergent serious adverse events will be quantified.