Trial Outcomes & Findings for A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers. (NCT NCT01920854)
NCT ID: NCT01920854
Last Updated: 2015-01-26
Results Overview
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
48 hours
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
Cohorts 1 - 6 Placebo
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
|
Cohort 1 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
6
|
6
|
5
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohorts 1 - 6 Placebo
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
|
Cohort 1 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
Cohorts 1 - 6 Placebo
n=12 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
25 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
6 participants
n=8 Participants
|
48 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 2 hrs
|
32.54286 micrograms/dL
Standard Deviation 32.58808
|
73.15 micrograms/dL
Standard Deviation 62.48
|
88.28333 micrograms/dL
Standard Deviation 22.29039
|
119.34 micrograms/dL
Standard Deviation 46.55242
|
150.3333 micrograms/dL
Standard Deviation 22.43806
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 4 hrs
|
43.75 micrograms/dL
Standard Deviation 39.09914
|
82.76 micrograms/dL
Standard Deviation 10.01489
|
143.4167 micrograms/dL
Standard Deviation 33.93585
|
206 micrograms/dL
Standard Deviation 37.76242
|
241.5 micrograms/dL
Standard Deviation 25.6963
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 6 hrs
|
46.3375 micrograms/dL
Standard Deviation 32.43362
|
86.1 micrograms/dL
Standard Deviation 23.73584
|
118.6 micrograms/dL
Standard Deviation 40.09489
|
179.0833 micrograms/dL
Standard Deviation 40.56158
|
214.5 micrograms/dL
Standard Deviation 31.14322
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 8 hrs
|
20.1875 micrograms/dL
Standard Deviation 19.10194
|
40.91667 micrograms/dL
Standard Deviation 32.76452
|
60.02833 micrograms/dL
Standard Deviation 38.13224
|
118.25 micrograms/dL
Standard Deviation 38.3246
|
148 micrograms/dL
Standard Deviation 28.2772
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 16 hrs
|
-23.0004 micrograms/dL
Standard Deviation 26.67792
|
-39.5 micrograms/dL
Standard Deviation 15.30849
|
-19.905 micrograms/dL
Standard Deviation 17.7931
|
-12.35 micrograms/dL
Standard Deviation 31.50294
|
-23.5 micrograms/dL
Standard Deviation 28.53482
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 0 hrs
|
18.87125 micrograms/dL
Standard Deviation 19.08355
|
14.625 micrograms/dL
Standard Deviation 13.54503
|
20.13333 micrograms/dL
Standard Deviation 9.256061
|
14.806 micrograms/dL
Standard Deviation 10.09701
|
31.73333 micrograms/dL
Standard Deviation 17.07579
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 0.5 hrs
|
19.25243 micrograms/dL
Standard Deviation 12.97435
|
22.075 micrograms/dL
Standard Deviation 15.44849
|
33.21167 micrograms/dL
Standard Deviation 16.22149
|
41.53333 micrograms/dL
Standard Deviation 17.55844
|
58.65 micrograms/dL
Standard Deviation 21.0115
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 1 hr
|
23.555 micrograms/dL
Standard Deviation 16.79989
|
40.34 micrograms/dL
Standard Deviation 14.2365
|
47.45 micrograms/dL
Standard Deviation 19.26954
|
67.24 micrograms/dL
Standard Deviation 29.08003
|
95.21667 micrograms/dL
Standard Deviation 18.84658
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 3 hrs
|
41.3125 micrograms/dL
Standard Deviation 31.5142
|
77.64 micrograms/dL
Standard Deviation 25.54981
|
112.7333 micrograms/dL
Standard Deviation 29.95721
|
173.4 micrograms/dL
Standard Deviation 17.38678
|
210 micrograms/dL
Standard Deviation 26.54807
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 4.5 hrs
|
46.99 micrograms/dL
Standard Deviation 33.692
|
94.38 micrograms/dL
Standard Deviation 12.827
|
150.8 micrograms/dL
Standard Deviation 39.0858
|
196.25 micrograms/dL
Standard Deviation 46.29885
|
258.3333 micrograms/dL
Standard Deviation 32.20973
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 5 hrs
|
50.74714 micrograms/dL
Standard Deviation 39.71965
|
88.88 micrograms/dL
Standard Deviation 30.95007
|
135.26 micrograms/dL
Standard Deviation 40.90584
|
207.5 micrograms/dL
Standard Deviation 41.23469
|
238.1667 micrograms/dL
Standard Deviation 27.28675
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 7.5 hrs
|
26.27143 micrograms/dL
Standard Deviation 25.89638
|
49.33333 micrograms/dL
Standard Deviation 35.15774
|
81.35 micrograms/dL
Standard Deviation 18.15717
|
131.45 micrograms/dL
Standard Deviation 31.91825
|
170.8333 micrograms/dL
Standard Deviation 27.63633
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 9 hrs
|
7.852857 micrograms/dL
Standard Deviation 25.84383
|
30.75 micrograms/dL
Standard Deviation 51.07636
|
44.21667 micrograms/dL
Standard Deviation 20.25452
|
79.96 micrograms/dL
Standard Deviation 32.5411
|
122.6833 micrograms/dL
Standard Deviation 21.64813
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 10 hrs
|
-0.1875 micrograms/dL
Standard Deviation 18.48079
|
-2.76 micrograms/dL
Standard Deviation 32.67052
|
24.02833 micrograms/dL
Standard Deviation 19.2209
|
64.68333 micrograms/dL
Standard Deviation 37.53566
|
81.01667 micrograms/dL
Standard Deviation 25.26099
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 12 hrs
|
-11.8538 micrograms/dL
Standard Deviation 20.68082
|
-30.9866 micrograms/dL
Standard Deviation 23.72293
|
-5.89333 micrograms/dL
Standard Deviation 17.29701
|
23.21667 micrograms/dL
Standard Deviation 42.48879
|
32.91667 micrograms/dL
Standard Deviation 22.9566
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 12.5 hrs
|
-11.7838 micrograms/dL
Standard Deviation 24.1043
|
-31.966 micrograms/dL
Standard Deviation 22.61386
|
-10.3888 micrograms/dL
Standard Deviation 20.13357
|
15.26667 micrograms/dL
Standard Deviation 27.3353
|
28.13333 micrograms/dL
Standard Deviation 32.85319
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 14 hrs
|
-14.525 micrograms/dL
Standard Deviation 23.13773
|
-38.3883 micrograms/dL
Standard Deviation 18.17201
|
-22.5 micrograms/dL
Standard Deviation 13.67333
|
0.895 micrograms/dL
Standard Deviation 27.98098
|
-6.56617 micrograms/dL
Standard Deviation 24.95741
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 20 hrs
|
-16.7163 micrograms/dL
Standard Deviation 29.37565
|
-43.8 micrograms/dL
Standard Deviation 13.72461
|
-23.655 micrograms/dL
Standard Deviation 21.6553
|
-11.0612 micrograms/dL
Standard Deviation 15.55449
|
-35.55 micrograms/dL
Standard Deviation 22.41006
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 24 hrs
|
10.34714 micrograms/dL
Standard Deviation 16.82299
|
11.7 micrograms/dL
Standard Deviation 33.80067
|
6.542 micrograms/dL
Standard Deviation 13.5174
|
2.05 micrograms/dL
Standard Deviation 15.61893
|
-11.655 micrograms/dL
Standard Deviation 20.10851
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 36 hrs
|
-4.24286 micrograms/dL
Standard Deviation 15.34727
|
-43.7666 micrograms/dL
Standard Deviation 28.14838
|
-9.72167 micrograms/dL
Standard Deviation 20.08234
|
-12.2612 micrograms/dL
Standard Deviation 17.42613
|
-27.3 micrograms/dL
Standard Deviation 15.28005
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
t = 48 hrs
|
21.73286 micrograms/dL
Standard Deviation 19.95647
|
11.47783 micrograms/dL
Standard Deviation 44.51915
|
21.82333 micrograms/dL
Standard Deviation 19.21886
|
41.4 micrograms/dL
Standard Deviation 50.85712
|
48.46 micrograms/dL
Standard Deviation 18.48764
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 12.5 hrs
|
-5.53333 micrograms/dL
Standard Deviation 28.14255
|
141.3833 micrograms/dL
Standard Deviation 49.73572
|
208.1667 micrograms/dL
Standard Deviation 51.0232
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 14 hrs
|
-2.9 micrograms/dL
Standard Deviation 24.60732
|
116.7 micrograms/dL
Standard Deviation 47.4452
|
161.9667 micrograms/dL
Standard Deviation 46.50513
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 16 hrs
|
-19.1667 micrograms/dL
Standard Deviation 15.64811
|
38.18 micrograms/dL
Standard Deviation 30.55899
|
92.43833 micrograms/dL
Standard Deviation 56.28477
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 18 hrs
|
-12.3 micrograms/dL
Standard Deviation 13.66711
|
25.84 micrograms/dL
Standard Deviation 37.53582
|
47.605 micrograms/dL
Standard Deviation 37.80162
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 20 hrs
|
-5.2889 micrograms/dL
Standard Deviation 7.137707
|
-6.06667 micrograms/dL
Standard Deviation 31.71553
|
-3.09 micrograms/dL
Standard Deviation 29.31886
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 24 hrs
|
21.62233 micrograms/dL
Standard Deviation 19.48729
|
-10.2333 micrograms/dL
Standard Deviation 35.97225
|
-20.0617 micrograms/dL
Standard Deviation 26.62087
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 30 hrs
|
31.485 micrograms/dL
Standard Deviation 48.38732
|
-30.225 micrograms/dL
Standard Deviation 27.25856
|
-25.6333 micrograms/dL
Standard Deviation 29.99492
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 36 hrs
|
-0.52333 micrograms/dL
Standard Deviation 21.42192
|
-23.15 micrograms/dL
Standard Deviation 40.39885
|
-34.6333 micrograms/dL
Standard Deviation 41.33162
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 48 hrs
|
34.03333 micrograms/dL
Standard Deviation 13.70632
|
36.02 micrograms/dL
Standard Deviation 26.44139
|
19.95 micrograms/dL
Standard Deviation 39.70616
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 2 hrs
|
24.9325 micrograms/dL
Standard Deviation 17.2084
|
77.62 micrograms/dL
Standard Deviation 17.82826
|
107.6333 micrograms/dL
Standard Deviation 43.33413
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 9 hrs
|
17.6 micrograms/dL
Standard Deviation 41.26835
|
167.2 micrograms/dL
Standard Deviation 42.3757
|
228.8333 micrograms/dL
Standard Deviation 44.96851
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 0 hrs
|
22.575 micrograms/dL
Standard Deviation 8.144272
|
15.55 micrograms/dL
Standard Deviation 11.59451
|
7.888333 micrograms/dL
Standard Deviation 33.94121
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 0.5 hrs
|
21.7 micrograms/dL
Standard Deviation 13.11602
|
26.25 micrograms/dL
Standard Deviation 13.70631
|
29.97167 micrograms/dL
Standard Deviation 33.57264
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 1 hr
|
23 micrograms/dL
Standard Deviation 11.37629
|
49.46667 micrograms/dL
Standard Deviation 12.52576
|
68.23333 micrograms/dL
Standard Deviation 44.6479
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 4 hrs
|
41.16667 micrograms/dL
Standard Deviation 32.85869
|
140.2 micrograms/dL
Standard Deviation 19.84187
|
197.6667 micrograms/dL
Standard Deviation 46.28031
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 6 hrs
|
42.975 micrograms/dL
Standard Deviation 36.03807
|
168.8 micrograms/dL
Standard Deviation 35.75891
|
232 micrograms/dL
Standard Deviation 48.90808
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
t = 12 hrs
|
2.175 micrograms/dL
Standard Deviation 29.20575
|
176 micrograms/dL
Standard Deviation 43.28972
|
214.5 micrograms/dL
Standard Deviation 49.31835
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 0 hrs
|
15.81588 micrograms/dL
Standard Deviation 15.29313
|
27.45 micrograms/dL
Standard Deviation 10.6442
|
24.76667 micrograms/dL
Standard Deviation 12.58438
|
18.03333 micrograms/dL
Standard Deviation 13.6192
|
34.47833 micrograms/dL
Standard Deviation 22.29513
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 0.5 hrs
|
16.12875 micrograms/dL
Standard Deviation 16.956
|
36.86667 micrograms/dL
Standard Deviation 8.992145
|
46.41667 micrograms/dL
Standard Deviation 11.35067
|
48.3 micrograms/dL
Standard Deviation 16.06275
|
62.93333 micrograms/dL
Standard Deviation 20.16231
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 1 hr
|
24.04125 micrograms/dL
Standard Deviation 23.55888
|
51.73333 micrograms/dL
Standard Deviation 10.18797
|
70.8 micrograms/dL
Standard Deviation 14.34489
|
81.31667 micrograms/dL
Standard Deviation 21.66614
|
102.8 micrograms/dL
Standard Deviation 22.60044
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 2 hrs
|
26.3875 micrograms/dL
Standard Deviation 17.3591
|
69.25 micrograms/dL
Standard Deviation 11.37853
|
112.55 micrograms/dL
Standard Deviation 17.88449
|
142.9 micrograms/dL
Standard Deviation 27.52417
|
166.6667 micrograms/dL
Standard Deviation 22.00606
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 3 hrs
|
36.7375 micrograms/dL
Standard Deviation 24.39203
|
96.06667 micrograms/dL
Standard Deviation 17.22355
|
1148.3333 micrograms/dL
Standard Deviation 26.3717
|
194.3333 micrograms/dL
Standard Deviation 39.70222
|
223.6667 micrograms/dL
Standard Deviation 21.58394
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 4 hrs
|
42.5375 micrograms/dL
Standard Deviation 27.70637
|
111.4167 micrograms/dL
Standard Deviation 21.85437
|
179.1667 micrograms/dL
Standard Deviation 35.79618
|
229.8333 micrograms/dL
Standard Deviation 58.21483
|
247.8333 micrograms/dL
Standard Deviation 28.47045
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 4.5 hrs
|
46.3125 micrograms/dL
Standard Deviation 26.86966
|
113 micrograms/dL
Standard Deviation 10.55936
|
183.5 micrograms/dL
Standard Deviation 37.35639
|
230.5 micrograms/dL
Standard Deviation 54.47844
|
259.1667 micrograms/dL
Standard Deviation 36.66833
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 5 hrs
|
47.8375 micrograms/dL
Standard Deviation 31.67153
|
105.95 micrograms/dL
Standard Deviation 21.48299
|
171.3333 micrograms/dL
Standard Deviation 34.4248
|
240.6667 micrograms/dL
Standard Deviation 42.41541
|
241.8333 micrograms/dL
Standard Deviation 21.80291
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 6 hrs
|
39.7125 micrograms/dL
Standard Deviation 23.02839
|
95.5 micrograms/dL
Standard Deviation 21.20547
|
149 micrograms/dL
Standard Deviation 31.89357
|
188.95 micrograms/dL
Standard Deviation 53.37429
|
222.8333 micrograms/dL
Standard Deviation 26.60388
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 7.5 hrs
|
21.84125 micrograms/dL
Standard Deviation 16.90949
|
62.58333 micrograms/dL
Standard Deviation 27.26891
|
95.25 micrograms/dL
Standard Deviation 18.04658
|
158.2667 micrograms/dL
Standard Deviation 63.67312
|
175.8333 micrograms/dL
Standard Deviation 27.83822
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 8 hrs
|
16.7375 micrograms/dL
Standard Deviation 14.66799
|
50.58333 micrograms/dL
Standard Deviation 27.42418
|
84.1 micrograms/dL
Standard Deviation 23.7459
|
125.1 micrograms/dL
Standard Deviation 50.25754
|
154.1667 micrograms/dL
Standard Deviation 30.0494
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 9 hrs
|
3.245 micrograms/dL
Standard Deviation 9.291451
|
30.23833 micrograms/dL
Standard Deviation 30.05141
|
52.21667 micrograms/dL
Standard Deviation 17.32494
|
104.1883 micrograms/dL
Standard Deviation 51.15559
|
125.35 micrograms/dL
Standard Deviation 23.78098
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 10 hrs
|
-5.4175 micrograms/dL
Standard Deviation 8.513109
|
4.028333 micrograms/dL
Standard Deviation 21.84233
|
25.38333 micrograms/dL
Standard Deviation 18.08142
|
67.95 micrograms/dL
Standard Deviation 42.27547
|
87.16667 micrograms/dL
Standard Deviation 31.49366
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 12 hrs
|
-18.8714 micrograms/dL
Standard Deviation 17.95569
|
-22.0445 micrograms/dL
Standard Deviation 14.59163
|
-7.33333 micrograms/dL
Standard Deviation 19.53363
|
28.65 micrograms/dL
Standard Deviation 22.83486
|
32.745 micrograms/dL
Standard Deviation 29.99864
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 12.5 hrs
|
-22.8429 micrograms/dL
Standard Deviation 22.18268
|
-27.4617 micrograms/dL
Standard Deviation 12.8595
|
-10.2667 micrograms/dL
Standard Deviation 22.21894
|
15.68333 micrograms/dL
Standard Deviation 19.74056
|
24.82833 micrograms/dL
Standard Deviation 38.29261
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 14 hrs
|
-25.4481 micrograms/dL
Standard Deviation 27.93334
|
-33.9617 micrograms/dL
Standard Deviation 16.56204
|
-14.85 micrograms/dL
Standard Deviation 28.31902
|
3.167167 micrograms/dL
Standard Deviation 13.43837
|
-6.195 micrograms/dL
Standard Deviation 29.40307
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 16 hrs
|
-29.4667 micrograms/dL
Standard Deviation 32.86135
|
-35.8 micrograms/dL
Standard Deviation 16.87637
|
-23.4283 micrograms/dL
Standard Deviation 26.12766
|
-12.0333 micrograms/dL
Standard Deviation 33.63212
|
-28.2167 micrograms/dL
Standard Deviation 30.50996
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 20 hrs
|
-20.7163 micrograms/dL
Standard Deviation 31.3054
|
-27.7 micrograms/dL
Standard Deviation 30.14558
|
-24.7233 micrograms/dL
Standard Deviation 22.46531
|
-18.1717 micrograms/dL
Standard Deviation 16.19425
|
-40.4883 micrograms/dL
Standard Deviation 27.31494
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 24 hrs
|
14.05 micrograms/dL
Standard Deviation 14.51925
|
21.505 micrograms/dL
Standard Deviation 37.16592
|
0.116667 micrograms/dL
Standard Deviation 16.23887
|
7.605 micrograms/dL
Standard Deviation 22.55452
|
-16.455 micrograms/dL
Standard Deviation 21.98194
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 36 hrs
|
-15.6767 micrograms/dL
Standard Deviation 31.81849
|
-39.8117 micrograms/dL
Standard Deviation 31.90823
|
-16.6567 micrograms/dL
Standard Deviation 16.39093
|
-11.74 micrograms/dL
Standard Deviation 14.89775
|
-37.3 micrograms/dL
Standard Deviation 14.24949
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 48 hrs
|
25.4875 micrograms/dL
Standard Deviation 16.85459
|
26.68333 micrograms/dL
Standard Deviation 51.62024
|
35.36667 micrograms/dL
Standard Deviation 12.16251
|
40.945 micrograms/dL
Standard Deviation 32.03071
|
42.94 micrograms/dL
Standard Deviation 12.77861
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 0 hrs
|
26.675 micrograms/dL
Standard Deviation 10.10095
|
17.13333 micrograms/dL
Standard Deviation 13.10836
|
22.31167 micrograms/dL
Standard Deviation 25.13075
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 0.5 hrs
|
24.6 micrograms/dL
Standard Deviation 12.80989
|
32.36667 micrograms/dL
Standard Deviation 14.44322
|
46.76667 micrograms/dL
Standard Deviation 25.7235
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 1 hr
|
31.35 micrograms/dL
Standard Deviation 14.11772
|
56.01667 micrograms/dL
Standard Deviation 12.43309
|
80.48333 micrograms/dL
Standard Deviation 26.35234
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 2 hrs
|
35.75 micrograms/dL
Standard Deviation 16.21532
|
93.36667 micrograms/dL
Standard Deviation 16.01058
|
136.3333 micrograms/dL
Standard Deviation 27.94041
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 4 hrs
|
50.9 micrograms/dL
Standard Deviation 26.83927
|
152 micrograms/dL
Standard Deviation 14.02854
|
222.5 micrograms/dL
Standard Deviation 41.28801
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 6 hrs
|
55 micrograms/dL
Standard Deviation 38.45179
|
186.8 micrograms/dL
Standard Deviation 27.12379
|
255.5 micrograms/dL
Standard Deviation 51.20059
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 9 hrs
|
24.285 micrograms/dL
Standard Deviation 43.9688
|
181.3333 micrograms/dL
Standard Deviation 34.92659
|
254.5 micrograms/dL
Standard Deviation 60.24201
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 12 hrs
|
-0.975 micrograms/dL
Standard Deviation 28.42761
|
178.5 micrograms/dL
Standard Deviation 47.26415
|
236.8333 micrograms/dL
Standard Deviation 62.58887
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 12.5 hrs
|
-3.86667 micrograms/dL
Standard Deviation 28.73436
|
157.6667 micrograms/dL
Standard Deviation 47.00496
|
237.8333 micrograms/dL
Standard Deviation 68.42051
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 14 hrs
|
-7.03333 micrograms/dL
Standard Deviation 19.74369
|
117.3333 micrograms/dL
Standard Deviation 45.18808
|
180.65 micrograms/dL
Standard Deviation 69.86598
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 16 hrs
|
-12.1867 micrograms/dL
Standard Deviation 10.43401
|
57.75 micrograms/dL
Standard Deviation 41.30815
|
114.3117 micrograms/dL
Standard Deviation 73.84014
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 18 hrs
|
-11.52 micrograms/dL
Standard Deviation 11.5913
|
17.705 micrograms/dL
Standard Deviation 33.84819
|
58.51667 micrograms/dL
Standard Deviation 63.66288
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 20 hrs
|
-0.67667 micrograms/dL
Standard Deviation 20.99592
|
-8.81667 micrograms/dL
Standard Deviation 25.93025
|
12.61167 micrograms/dL
Standard Deviation 53.50657
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 24 hrs
|
30.39 micrograms/dL
Standard Deviation 23.14673
|
-12.0567 micrograms/dL
Standard Deviation 25.6596
|
-9.53833 micrograms/dL
Standard Deviation 41.94388
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 30 hrs
|
26.44667 micrograms/dL
Standard Deviation 41.6933
|
-18.8283 micrograms/dL
Standard Deviation 30.65685
|
-22.9778 micrograms/dL
Standard Deviation 23.78139
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 36 hrs
|
-5.4 micrograms/dL
Standard Deviation 27.97803
|
-28.1672 micrograms/dL
Standard Deviation 32.82391
|
-28.35 micrograms/dL
Standard Deviation 35.19118
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
t = 48 hrs
|
40.46667 micrograms/dL
Standard Deviation 15.25036
|
41.026 micrograms/dL
Standard Deviation 34.08901
|
30.78333 micrograms/dL
Standard Deviation 48.96756
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 1 hr
|
345 micrograms/dL
Standard Deviation 51.6
|
318 micrograms/dL
Standard Deviation 29.5
|
334 micrograms/dL
Standard Deviation 22.8
|
348 micrograms/dL
Standard Deviation 53.9
|
352 micrograms/dL
Standard Deviation 35.7
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 4 hrs
|
348 micrograms/dL
Standard Deviation 41.1
|
312 micrograms/dL
Standard Deviation 29.4
|
328 micrograms/dL
Standard Deviation 23.4
|
340 micrograms/dL
Standard Deviation 51.2
|
341 micrograms/dL
Standard Deviation 37.4
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 4.5 hrs
|
359 micrograms/dL
Standard Deviation 45.1
|
324 micrograms/dL
Standard Deviation 35.7
|
339 micrograms/dL
Standard Deviation 22.3
|
337 micrograms/dL
Standard Deviation 46.9
|
352 micrograms/dL
Standard Deviation 35.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 5 hrs
|
358 micrograms/dL
Standard Deviation 43.6
|
318 micrograms/dL
Standard Deviation 27.6
|
338 micrograms/dL
Standard Deviation 24.4
|
352 micrograms/dL
Standard Deviation 42.6
|
350 micrograms/dL
Standard Deviation 37.9
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 8 hrs
|
359 micrograms/dL
Standard Deviation 38.6
|
319 micrograms/dL
Standard Deviation 27.7
|
339 micrograms/dL
Standard Deviation 25.2
|
356 micrograms/dL
Standard Deviation 54.4
|
348 micrograms/dL
Standard Deviation 34.6
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 0 hrs
|
350 micrograms/dL
Standard Deviation 44.2
|
318 micrograms/dL
Standard Deviation 28.3
|
334 micrograms/dL
Standard Deviation 23.8
|
352 micrograms/dL
Standard Deviation 53.1
|
352 micrograms/dL
Standard Deviation 35.9
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 0.5 hrs
|
344 micrograms/dL
Standard Deviation 41.6
|
312 micrograms/dL
Standard Deviation 27.3
|
328 micrograms/dL
Standard Deviation 24.9
|
344 micrograms/dL
Standard Deviation 54.5
|
348 micrograms/dL
Standard Deviation 37.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 2 hrs
|
346 micrograms/dL
Standard Deviation 45.6
|
312 micrograms/dL
Standard Deviation 31.9
|
330 micrograms/dL
Standard Deviation 29.9
|
347 micrograms/dL
Standard Deviation 56.6
|
342 micrograms/dL
Standard Deviation 36.6
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 3 hrs
|
348 micrograms/dL
Standard Deviation 43
|
313 micrograms/dL
Standard Deviation 28.5
|
329 micrograms/dL
Standard Deviation 26.6
|
344 micrograms/dL
Standard Deviation 52.8
|
342 micrograms/dL
Standard Deviation 38.4
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 6 hrs
|
356 micrograms/dL
Standard Deviation 44
|
315 micrograms/dL
Standard Deviation 26
|
338 micrograms/dL
Standard Deviation 24.8
|
356 micrograms/dL
Standard Deviation 53.6
|
348 micrograms/dL
Standard Deviation 37.8
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 7.5 hrs
|
347 micrograms/dL
Standard Deviation 56.1
|
318 micrograms/dL
Standard Deviation 27
|
332 micrograms/dL
Standard Deviation 29.3
|
355 micrograms/dL
Standard Deviation 52.8
|
348 micrograms/dL
Standard Deviation 36.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 9 hrs
|
348 micrograms/dL
Standard Deviation 51.6
|
324 micrograms/dL
Standard Deviation 27
|
338 micrograms/dL
Standard Deviation 29.6
|
351 micrograms/dL
Standard Deviation 47.2
|
349 micrograms/dL
Standard Deviation 34.9
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 10 hrs
|
352 micrograms/dL
Standard Deviation 41.4
|
317 micrograms/dL
Standard Deviation 26.7
|
338 micrograms/dL
Standard Deviation 28.8
|
355 micrograms/dL
Standard Deviation 52.4
|
347 micrograms/dL
Standard Deviation 34.6
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 12 hrs
|
351 micrograms/dL
Standard Deviation 43
|
319 micrograms/dL
Standard Deviation 26.3
|
333 micrograms/dL
Standard Deviation 29.5
|
360 micrograms/dL
Standard Deviation 53.5
|
344 micrograms/dL
Standard Deviation 33.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 12.5 hrs
|
344 micrograms/dL
Standard Deviation 52.7
|
316 micrograms/dL
Standard Deviation 30.7
|
336 micrograms/dL
Standard Deviation 23.5
|
351 micrograms/dL
Standard Deviation 46.3
|
350 micrograms/dL
Standard Deviation 25.8
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 14 hrs
|
340 micrograms/dL
Standard Deviation 61.9
|
316 micrograms/dL
Standard Deviation 31.1
|
335 micrograms/dL
Standard Deviation 31.8
|
356 micrograms/dL
Standard Deviation 48.4
|
344 micrograms/dL
Standard Deviation 39.6
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 16 hrs
|
341 micrograms/dL
Standard Deviation 41.1
|
304 micrograms/dL
Standard Deviation 46.8
|
327 micrograms/dL
Standard Deviation 27.1
|
353 micrograms/dL
Standard Deviation 27.5
|
344 micrograms/dL
Standard Deviation 36.9
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 20 hrs
|
342 micrograms/dL
Standard Deviation 48.8
|
301 micrograms/dL
Standard Deviation 40.8
|
326 micrograms/dL
Standard Deviation 23.4
|
350 micrograms/dL
Standard Deviation 52.3
|
338 micrograms/dL
Standard Deviation 32.4
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 24 hrs
|
355 micrograms/dL
Standard Deviation 43.4
|
314 micrograms/dL
Standard Deviation 30.8
|
346 micrograms/dL
Standard Deviation 22.6
|
362 micrograms/dL
Standard Deviation 50
|
353 micrograms/dL
Standard Deviation 35
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 36 hrs
|
362 micrograms/dL
Standard Deviation 39.4
|
318 micrograms/dL
Standard Deviation 24.8
|
344 micrograms/dL
Standard Deviation 24.6
|
364 micrograms/dL
Standard Deviation 50.4
|
357 micrograms/dL
Standard Deviation 38.4
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
t = 48 hrs
|
364 micrograms/dL
Standard Deviation 43.2
|
320 micrograms/dL
Standard Deviation 30.5
|
346 micrograms/dL
Standard Deviation 19.3
|
370 micrograms/dL
Standard Deviation 54.4
|
352 micrograms/dL
Standard Deviation 36.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 1 hr
|
340 micrograms/dL
Standard Deviation 15.9
|
338 micrograms/dL
Standard Deviation 42
|
336 micrograms/dL
Standard Deviation 40.4
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 30 hrs
|
344 micrograms/dL
Standard Deviation 28.3
|
339 micrograms/dL
Standard Deviation 42.2
|
350 micrograms/dL
Standard Deviation 35.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 0 hrs
|
345 micrograms/dL
Standard Deviation 22.3
|
346 micrograms/dL
Standard Deviation 49.8
|
340 micrograms/dL
Standard Deviation 41.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 0.5 hrs
|
332 micrograms/dL
Standard Deviation 18.8
|
328 micrograms/dL
Standard Deviation 41.8
|
328 micrograms/dL
Standard Deviation 36.6
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 2 hrs
|
337 micrograms/dL
Standard Deviation 17.6
|
336 micrograms/dL
Standard Deviation 43.8
|
335 micrograms/dL
Standard Deviation 36.6
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 4 hrs
|
338 micrograms/dL
Standard Deviation 19.1
|
336 micrograms/dL
Standard Deviation 42.4
|
335 micrograms/dL
Standard Deviation 43.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 6 hrs
|
334 micrograms/dL
Standard Deviation 22.9
|
338 micrograms/dL
Standard Deviation 40.8
|
317 micrograms/dL
Standard Deviation 41.3
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 9 hrs
|
330 micrograms/dL
Standard Deviation 19.5
|
324 micrograms/dL
Standard Deviation 37.8
|
318 micrograms/dL
Standard Deviation 37.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 12 hrs
|
334 micrograms/dL
Standard Deviation 33.3
|
319 micrograms/dL
Standard Deviation 40.2
|
308 micrograms/dL
Standard Deviation 35.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 12.5 hrs
|
333 micrograms/dL
Standard Deviation 20.8
|
325 micrograms/dL
Standard Deviation 37.1
|
323 micrograms/dL
Standard Deviation 35.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 14 hrs
|
339 micrograms/dL
Standard Deviation 19.3
|
328 micrograms/dL
Standard Deviation 41.7
|
325 micrograms/dL
Standard Deviation 31.8
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 16 hrs
|
338 micrograms/dL
Standard Deviation 21.4
|
340 micrograms/dL
Standard Deviation 37.8
|
325 micrograms/dL
Standard Deviation 32.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 18 hrs
|
342 micrograms/dL
Standard Deviation 13.9
|
337 micrograms/dL
Standard Deviation 40.2
|
330 micrograms/dL
Standard Deviation 34.3
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 20 hrs
|
337 micrograms/dL
Standard Deviation 18.9
|
329 micrograms/dL
Standard Deviation 40.4
|
325 micrograms/dL
Standard Deviation 39
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 24 hrs
|
346 micrograms/dL
Standard Deviation 31.2
|
344 micrograms/dL
Standard Deviation 43.3
|
342 micrograms/dL
Standard Deviation 39.4
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 36 hrs
|
346 micrograms/dL
Standard Deviation 33.7
|
344 micrograms/dL
Standard Deviation 46.4
|
345 micrograms/dL
Standard Deviation 35.4
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
t = 48 hrs
|
352 micrograms/dL
Standard Deviation 20.8
|
337 micrograms/dL
Standard Deviation 42.6
|
343 micrograms/dL
Standard Deviation 38.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 4.5 hrs
|
0.0952 micrograms/dL
Standard Deviation 13.2
|
-9.79 micrograms/dL
Standard Deviation 26.5
|
-32.9 micrograms/dL
Standard Deviation 16.5
|
-27 micrograms/dL
Standard Deviation 22
|
0.744 micrograms/dL
Standard Deviation 13.3
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 7.5 hrs
|
3.3 micrograms/dL
Standard Deviation 14.5
|
-6.01 micrograms/dL
Standard Deviation 10.1
|
-13.9 micrograms/dL
Standard Deviation 13.6
|
-27.4 micrograms/dL
Standard Deviation 44.4
|
-5.09 micrograms/dL
Standard Deviation 16.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 8 hrs
|
3.37 micrograms/dL
Standard Deviation 10.6
|
-2.43 micrograms/dL
Standard Deviation 9.75
|
-24 micrograms/dL
Standard Deviation 20.1
|
-7.72 micrograms/dL
Standard Deviation 25.1
|
-5.74 micrograms/dL
Standard Deviation 11.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 0 hrs
|
2.98 micrograms/dL
Standard Deviation 7.07
|
-5.44 micrograms/dL
Standard Deviation 5.35
|
-4.66 micrograms/dL
Standard Deviation 6.42
|
-4.74 micrograms/dL
Standard Deviation 7.01
|
-1.42 micrograms/dL
Standard Deviation 5.22
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 0.5 hrs
|
5.93 micrograms/dL
Standard Deviation 11.5
|
-7.54 micrograms/dL
Standard Deviation 8.74
|
-13.2 micrograms/dL
Standard Deviation 9.7
|
-7.65 micrograms/dL
Standard Deviation 21.8
|
-4.92 micrograms/dL
Standard Deviation 6.33
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 1 hr
|
-0.554 micrograms/dL
Standard Deviation 11.6
|
-2.51 micrograms/dL
Standard Deviation 10.1
|
-23.4 micrograms/dL
Standard Deviation 9
|
-13.9 micrograms/dL
Standard Deviation 35.8
|
-7.54 micrograms/dL
Standard Deviation 3.74
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 2 hrs
|
5.07 micrograms/dL
Standard Deviation 19.6
|
12 micrograms/dL
Standard Deviation 53.5
|
-24.5 micrograms/dL
Standard Deviation 11.9
|
-26.9 micrograms/dL
Standard Deviation 29.5
|
-13.8 micrograms/dL
Standard Deviation 6.34
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 3 hrs
|
4.5 micrograms/dL
Standard Deviation 15.9
|
-11.9 micrograms/dL
Standard Deviation 10.3
|
-35.6 micrograms/dL
Standard Deviation 9.85
|
-23.7 micrograms/dL
Standard Deviation 30.1
|
-9.69 micrograms/dL
Standard Deviation 6.81
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 4 hrs
|
1.17 micrograms/dL
Standard Deviation 12.6
|
-13.2 micrograms/dL
Standard Deviation 19.8
|
-35.7 micrograms/dL
Standard Deviation 16.4
|
-24.3 micrograms/dL
Standard Deviation 23.5
|
-6.96 micrograms/dL
Standard Deviation 5.75
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 5 hrs
|
1.01 micrograms/dL
Standard Deviation 15.4
|
-10.7 micrograms/dL
Standard Deviation 11.5
|
-32.7 micrograms/dL
Standard Deviation 15
|
-34 micrograms/dL
Standard Deviation 19.7
|
-2.92 micrograms/dL
Standard Deviation 15.3
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 6 hrs
|
6.55 micrograms/dL
Standard Deviation 20.1
|
-10.1 micrograms/dL
Standard Deviation 11.3
|
-30.4 micrograms/dL
Standard Deviation 13.4
|
-11 micrograms/dL
Standard Deviation 28
|
-7.16 micrograms/dL
Standard Deviation 13.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 9 hrs
|
6.31 micrograms/dL
Standard Deviation 20.8
|
7.69 micrograms/dL
Standard Deviation 26.8
|
-8.02 micrograms/dL
Standard Deviation 7.3
|
-27 micrograms/dL
Standard Deviation 36
|
-2.44 micrograms/dL
Standard Deviation 16.2
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 10 hrs
|
5.16 micrograms/dL
Standard Deviation 12.8
|
1.51 micrograms/dL
Standard Deviation 6.03
|
-1.37 micrograms/dL
Standard Deviation 4.46
|
-4.22 micrograms/dL
Standard Deviation 31.2
|
-5.56 micrograms/dL
Standard Deviation 11.3
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 12 hrs
|
9.52 micrograms/dL
Standard Deviation 14.9
|
-3.11 micrograms/dL
Standard Deviation 9.14
|
1.43 micrograms/dL
Standard Deviation 5.26
|
-6.32 micrograms/dL
Standard Deviation 42.9
|
-0.472 micrograms/dL
Standard Deviation 16.2
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 12.5 hrs
|
12.7 micrograms/dL
Standard Deviation 21.2
|
1.17 micrograms/dL
Standard Deviation 9.66
|
-0.139 micrograms/dL
Standard Deviation 6.84
|
-1.3 micrograms/dL
Standard Deviation 30.4
|
2.66 micrograms/dL
Standard Deviation 11.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 14 hrs
|
11 micrograms/dL
Standard Deviation 12.8
|
2.82 micrograms/dL
Standard Deviation 12.6
|
-3.44 micrograms/dL
Standard Deviation 17.9
|
-3.15 micrograms/dL
Standard Deviation 28.3
|
-1.01 micrograms/dL
Standard Deviation 6.73
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 16 hrs
|
6.32 micrograms/dL
Standard Deviation 11.1
|
4.85 micrograms/dL
Standard Deviation 12.7
|
3.51 micrograms/dL
Standard Deviation 10.3
|
-1.2 micrograms/dL
Standard Deviation 32.5
|
4.08 micrograms/dL
Standard Deviation 10.7
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 20 hrs
|
3.92 micrograms/dL
Standard Deviation 9.3
|
0.353 micrograms/dL
Standard Deviation 22.2
|
1.06 micrograms/dL
Standard Deviation 6.27
|
6.22 micrograms/dL
Standard Deviation 25.3
|
4.29 micrograms/dL
Standard Deviation 6.91
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 24 hrs
|
-3.37 micrograms/dL
Standard Deviation 4.87
|
-6.39 micrograms/dL
Standard Deviation 12.5
|
5.47 micrograms/dL
Standard Deviation 5.98
|
-6.43 micrograms/dL
Standard Deviation 31.1
|
4.16 micrograms/dL
Standard Deviation 9.23
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 36 hrs
|
2.97 micrograms/dL
Standard Deviation 10
|
1.51 micrograms/dL
Standard Deviation 15.2
|
6.93 micrograms/dL
Standard Deviation 5.2
|
-1.4 micrograms/dL
Standard Deviation 23.6
|
9.36 micrograms/dL
Standard Deviation 8.63
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 48 hrs
|
-6.73 micrograms/dL
Standard Deviation 14.6
|
-7.56 micrograms/dL
Standard Deviation 11.7
|
-13.6 micrograms/dL
Standard Deviation 19.7
|
-1.65 micrograms/dL
Standard Deviation 24.3
|
4.74 micrograms/dL
Standard Deviation 14.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 0 hrs
|
-4.08 micrograms/dL
Standard Deviation 2.22
|
-1.58 micrograms/dL
Standard Deviation 2.45
|
-13.9 micrograms/dL
Standard Deviation 25.8
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 0.5 hrs
|
-7.44 micrograms/dL
Standard Deviation 8.71
|
-5.95 micrograms/dL
Standard Deviation 7.54
|
-14.8 micrograms/dL
Standard Deviation 26.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 1 hr
|
-6.63 micrograms/dL
Standard Deviation 4.35
|
-5.93 micrograms/dL
Standard Deviation 8.93
|
-9.99 micrograms/dL
Standard Deviation 38.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 2 hrs
|
-10.4 micrograms/dL
Standard Deviation 7.52
|
-12.9 micrograms/dL
Standard Deviation 23.4
|
-20.7 micrograms/dL
Standard Deviation 28.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 4 hrs
|
-6.57 micrograms/dL
Standard Deviation 4.26
|
-10.1 micrograms/dL
Standard Deviation 8.65
|
-17.6 micrograms/dL
Standard Deviation 28.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 6 hrs
|
-10.8 micrograms/dL
Standard Deviation 12.3
|
-15.8 micrograms/dL
Standard Deviation 16.4
|
-18.1 micrograms/dL
Standard Deviation 28.6
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 9 hrs
|
-6.53 micrograms/dL
Standard Deviation 13.2
|
-10.1 micrograms/dL
Standard Deviation 18.3
|
-19.8 micrograms/dL
Standard Deviation 28.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 12 hrs
|
3.17 micrograms/dL
Standard Deviation 2.29
|
-11.7 micrograms/dL
Standard Deviation 12.8
|
-18.4 micrograms/dL
Standard Deviation 22.4
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 12.5 hrs
|
-1.63 micrograms/dL
Standard Deviation 1.54
|
-16.3 micrograms/dL
Standard Deviation 15.5
|
-20.2 micrograms/dL
Standard Deviation 28.3
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 14 hrs
|
0.0167 micrograms/dL
Standard Deviation 1.39
|
-3.38 micrograms/dL
Standard Deviation 7.01
|
-14.2 micrograms/dL
Standard Deviation 33.5
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 16 hrs
|
-6.97 micrograms/dL
Standard Deviation 13.6
|
-6.93 micrograms/dL
Standard Deviation 9.07
|
-17.9 micrograms/dL
Standard Deviation 29.5
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 18 hrs
|
-0.767 micrograms/dL
Standard Deviation 9.7
|
1.81 micrograms/dL
Standard Deviation 8.29
|
-8.14 micrograms/dL
Standard Deviation 28
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 20 hrs
|
-4.6 micrograms/dL
Standard Deviation 14.9
|
2.75 micrograms/dL
Standard Deviation 8.15
|
-14.4 micrograms/dL
Standard Deviation 31
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 24 hrs
|
-8.63 micrograms/dL
Standard Deviation 8.31
|
1.83 micrograms/dL
Standard Deviation 16.3
|
-10.8 micrograms/dL
Standard Deviation 27.5
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 30 hrs
|
-3.68 micrograms/dL
Standard Deviation 3.09
|
1.22 micrograms/dL
Standard Deviation 9.34
|
-2.87 micrograms/dL
Standard Deviation 35.6
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 36 hrs
|
4.9 micrograms/dL
Standard Deviation 9.01
|
5.32 micrograms/dL
Standard Deviation 20.5
|
-6.44 micrograms/dL
Standard Deviation 29.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
t = 48 hrs
|
-4.63 micrograms/dL
Standard Deviation 1.7
|
-4.03 micrograms/dL
Standard Deviation 22.1
|
-8.46 micrograms/dL
Standard Deviation 36.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 16 hrs
|
21 micrograms/dL
Standard Deviation 24.1
|
22.5 micrograms/dL
Standard Deviation 21.5
|
18.5 micrograms/dL
Standard Deviation 30.1
|
10.8 micrograms/dL
Standard Deviation 10.6
|
16.5 micrograms/dL
Standard Deviation 33.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 20 hrs
|
11.8 micrograms/dL
Standard Deviation 19.4
|
11.9 micrograms/dL
Standard Deviation 28.5
|
19 micrograms/dL
Standard Deviation 25.4
|
15.3 micrograms/dL
Standard Deviation 15.5
|
23.1 micrograms/dL
Standard Deviation 26.3
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 12.5 hrs
|
17.1 micrograms/dL
Standard Deviation 10.6
|
26 micrograms/dL
Standard Deviation 13.6
|
14 micrograms/dL
Standard Deviation 32
|
-16.7 micrograms/dL
Standard Deviation 33.7
|
-30.6 micrograms/dL
Standard Deviation 34.4
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 0 hrs
|
-15.7 micrograms/dL
Standard Deviation 16.3
|
-27 micrograms/dL
Standard Deviation 9.55
|
-22.9 micrograms/dL
Standard Deviation 10.7
|
-17.9 micrograms/dL
Standard Deviation 13.9
|
-37.4 micrograms/dL
Standard Deviation 24
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 0.5 hrs
|
-22.4 micrograms/dL
Standard Deviation 19.4
|
-41.5 micrograms/dL
Standard Deviation 7.97
|
-50.2 micrograms/dL
Standard Deviation 10.7
|
-56.8 micrograms/dL
Standard Deviation 17.3
|
-70.7 micrograms/dL
Standard Deviation 23.8
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 1 hr
|
-29.1 micrograms/dL
Standard Deviation 34.7
|
-51.1 micrograms/dL
Standard Deviation 9.91
|
-68.7 micrograms/dL
Standard Deviation 10.6
|
-85.9 micrograms/dL
Standard Deviation 19.2
|
-106 micrograms/dL
Standard Deviation 22.6
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 2 hrs
|
-30.3 micrograms/dL
Standard Deviation 24.2
|
-74.1 micrograms/dL
Standard Deviation 10.9
|
-115 micrograms/dL
Standard Deviation 22.9
|
-148 micrograms/dL
Standard Deviation 25.9
|
-179 micrograms/dL
Standard Deviation 25.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 3 hrs
|
-38.9 micrograms/dL
Standard Deviation 26.7
|
-100 micrograms/dL
Standard Deviation 21.4
|
-152 micrograms/dL
Standard Deviation 26.2
|
-201 micrograms/dL
Standard Deviation 39.2
|
-229 micrograms/dL
Standard Deviation 30.6
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 4 hrs
|
-44.8 micrograms/dL
Standard Deviation 31.2
|
-117 micrograms/dL
Standard Deviation 22.6
|
-182 micrograms/dL
Standard Deviation 36.1
|
-242 micrograms/dL
Standard Deviation 58.8
|
-246 micrograms/dL
Standard Deviation 29.4
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 4.5 hrs
|
-37.9 micrograms/dL
Standard Deviation 33.2
|
-103 micrograms/dL
Standard Deviation 10.6
|
-175 micrograms/dL
Standard Deviation 34.5
|
-222 micrograms/dL
Standard Deviation 59.4
|
-243 micrograms/dL
Standard Deviation 30.8
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 5 hrs
|
-39.9 micrograms/dL
Standard Deviation 37.8
|
-105 micrograms/dL
Standard Deviation 25.5
|
-166 micrograms/dL
Standard Deviation 35.9
|
-237 micrograms/dL
Standard Deviation 60.6
|
-239 micrograms/dL
Standard Deviation 30.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 6 hrs
|
-34.5 micrograms/dL
Standard Deviation 29.7
|
-97.3 micrograms/dL
Standard Deviation 25.8
|
-143 micrograms/dL
Standard Deviation 31.4
|
-185 micrograms/dL
Standard Deviation 50.9
|
-228 micrograms/dL
Standard Deviation 33.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 7.5 hrs
|
-25.1 micrograms/dL
Standard Deviation 35.4
|
-61.8 micrograms/dL
Standard Deviation 28.7
|
-95.3 micrograms/dL
Standard Deviation 26.9
|
-156 micrograms/dL
Standard Deviation 68.9
|
-183 micrograms/dL
Standard Deviation 32.3
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 8 hrs
|
-8.54 micrograms/dL
Standard Deviation 15.5
|
-48.9 micrograms/dL
Standard Deviation 26.6
|
-77.4 micrograms/dL
Standard Deviation 26.2
|
-121 micrograms/dL
Standard Deviation 52.5
|
-161 micrograms/dL
Standard Deviation 34.8
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 9 hrs
|
-5.54 micrograms/dL
Standard Deviation 23.6
|
-23.6 micrograms/dL
Standard Deviation 22.9
|
-46.5 micrograms/dL
Standard Deviation 25.5
|
-106 micrograms/dL
Standard Deviation 56.4
|
-132 micrograms/dL
Standard Deviation 29.7
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 10 hrs
|
7 micrograms/dL
Standard Deviation 12
|
-3.71 micrograms/dL
Standard Deviation 18.1
|
-20 micrograms/dL
Standard Deviation 23.6
|
-65.7 micrograms/dL
Standard Deviation 50.1
|
-95.5 micrograms/dL
Standard Deviation 34.9
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 12 hrs
|
19.4 micrograms/dL
Standard Deviation 10.5
|
24.4 micrograms/dL
Standard Deviation 13.7
|
8.56 micrograms/dL
Standard Deviation 26.4
|
-21.5 micrograms/dL
Standard Deviation 33.7
|
-43.7 micrograms/dL
Standard Deviation 32
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 14 hrs
|
16 micrograms/dL
Standard Deviation 8.71
|
32.8 micrograms/dL
Standard Deviation 11.5
|
17.7 micrograms/dL
Standard Deviation 37.1
|
0.667 micrograms/dL
Standard Deviation 20
|
-5.4 micrograms/dL
Standard Deviation 34.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 24 hrs
|
-9.1 micrograms/dL
Standard Deviation 13.8
|
-24.7 micrograms/dL
Standard Deviation 32.2
|
13.8 micrograms/dL
Standard Deviation 22.8
|
1.57 micrograms/dL
Standard Deviation 23
|
14 micrograms/dL
Standard Deviation 16.5
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 36 hrs
|
28.1 micrograms/dL
Standard Deviation 28.6
|
41.1 micrograms/dL
Standard Deviation 30.1
|
28.6 micrograms/dL
Standard Deviation 19.5
|
23.1 micrograms/dL
Standard Deviation 15.1
|
38.7 micrograms/dL
Standard Deviation 21.1
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 48 hrs
|
-12.2 micrograms/dL
Standard Deviation 25.3
|
-23.4 micrograms/dL
Standard Deviation 46.3
|
-21.1 micrograms/dL
Standard Deviation 16
|
-23.8 micrograms/dL
Standard Deviation 38.3
|
-44.4 micrograms/dL
Standard Deviation 18.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 48 hrs
|
-26.2 micrograms/dL
Standard Deviation 25.3
|
-35.8 micrograms/dL
Standard Deviation 36.2
|
-24.5 micrograms/dL
Standard Deviation 54.8
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 0 hrs
|
-19.7 micrograms/dL
Standard Deviation 8.82
|
-12.4 micrograms/dL
Standard Deviation 17.6
|
-19.4 micrograms/dL
Standard Deviation 29.5
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 0.5 hrs
|
-30.4 micrograms/dL
Standard Deviation 11.6
|
-46.5 micrograms/dL
Standard Deviation 9.79
|
-56.3 micrograms/dL
Standard Deviation 29.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 1 hr
|
-29.7 micrograms/dL
Standard Deviation 16.2
|
-59.8 micrograms/dL
Standard Deviation 8.85
|
-81.3 micrograms/dL
Standard Deviation 29.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 2 hrs
|
-37.1 micrograms/dL
Standard Deviation 19.2
|
-99.2 micrograms/dL
Standard Deviation 14
|
-138 micrograms/dL
Standard Deviation 32.9
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 4 hrs
|
-51.2 micrograms/dL
Standard Deviation 25.8
|
-158 micrograms/dL
Standard Deviation 21.6
|
-216 micrograms/dL
Standard Deviation 27.9
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 6 hrs
|
-58.7 micrograms/dL
Standard Deviation 41.6
|
-189 micrograms/dL
Standard Deviation 38.5
|
-247 micrograms/dL
Standard Deviation 37.5
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 9 hrs
|
-32.4 micrograms/dL
Standard Deviation 46.3
|
-199 micrograms/dL
Standard Deviation 41.6
|
-246 micrograms/dL
Standard Deviation 44.2
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 12 hrs
|
-3.59 micrograms/dL
Standard Deviation 30.8
|
-201 micrograms/dL
Standard Deviation 51.9
|
-241 micrograms/dL
Standard Deviation 51.8
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 12.5 hrs
|
-1.21 micrograms/dL
Standard Deviation 29.8
|
-174 micrograms/dL
Standard Deviation 66.1
|
-236 micrograms/dL
Standard Deviation 60.7
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 14 hrs
|
8.29 micrograms/dL
Standard Deviation 17.2
|
-131 micrograms/dL
Standard Deviation 52.9
|
-193 micrograms/dL
Standard Deviation 76.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 16 hrs
|
11.8 micrograms/dL
Standard Deviation 11.2
|
-59.7 micrograms/dL
Standard Deviation 58.2
|
-126 micrograms/dL
Standard Deviation 76.4
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 18 hrs
|
15.4 micrograms/dL
Standard Deviation 20.3
|
-22.3 micrograms/dL
Standard Deviation 44.6
|
-65.7 micrograms/dL
Standard Deviation 65.6
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 20 hrs
|
-0.0778 micrograms/dL
Standard Deviation 30.5
|
-3.63 micrograms/dL
Standard Deviation 33.6
|
-24.7 micrograms/dL
Standard Deviation 52.8
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 24 hrs
|
-22.8 micrograms/dL
Standard Deviation 33.3
|
14.6 micrograms/dL
Standard Deviation 24.6
|
14.3 micrograms/dL
Standard Deviation 49.4
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 30 hrs
|
-20.9 micrograms/dL
Standard Deviation 53.3
|
15.9 micrograms/dL
Standard Deviation 35.5
|
35.8 micrograms/dL
Standard Deviation 28.1
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
t = 36 hrs
|
13.7 micrograms/dL
Standard Deviation 39.4
|
30.1 micrograms/dL
Standard Deviation 37.7
|
36.6 micrograms/dL
Standard Deviation 34.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (1 day)Population: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=12 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
|
306.583 mg/dL
Standard Deviation 35.1606
|
283.500 mg/dL
Standard Deviation 29.9850
|
315.500 mg/dL
Standard Deviation 40.7909
|
348.333 mg/dL
Standard Deviation 59.9956
|
303.833 mg/dL
Standard Deviation 47.2966
|
314.571 mg/dL
Standard Deviation 52.6841
|
304.167 mg/dL
Standard Deviation 53.2143
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 0 hrs
|
25.70875 percentage of saturation
Standard Deviation 18.521548
|
41.85 percentage of saturation
Standard Deviation 12.577559
|
27.466667 percentage of saturation
Standard Deviation 13.091626
|
26.383333 percentage of saturation
Standard Deviation 10.936986
|
39.066667 percentage of saturation
Standard Deviation 10.129495
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 0.5 hrs
|
26.375 percentage of saturation
Standard Deviation 19.6707
|
45.583333 percentage of saturation
Standard Deviation 12.795533
|
34.5 percentage of saturation
Standard Deviation 12.94805
|
35.716667 percentage of saturation
Standard Deviation 11.168781
|
47.85 percentage of saturation
Standard Deviation 10.774368
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 1 hr
|
29.4125 percentage of saturation
Standard Deviation 23.073141
|
49.533333 percentage of saturation
Standard Deviation 13.224019
|
41.266667 percentage of saturation
Standard Deviation 14.069921
|
45.016667 percentage of saturation
Standard Deviation 11.995902
|
58.583333 percentage of saturation
Standard Deviation 11.177373
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 2 hrs
|
29.5625 percentage of saturation
Standard Deviation 21.098337
|
56.15 percentage of saturation
Standard Deviation 13.052624
|
54.75 percentage of saturation
Standard Deviation 15.895377
|
63.05 percentage of saturation
Standard Deviation 13.895719
|
79.45 percentage of saturation
Standard Deviation 14.417039
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 3 hrs
|
32.1875 percentage of saturation
Standard Deviation 21.176904
|
64.666667 percentage of saturation
Standard Deviation 16.043898
|
65.866667 percentage of saturation
Standard Deviation 17.335128
|
78.15 percentage of saturation
Standard Deviation 14.831015
|
96.066667 percentage of saturation
Standard Deviation 12.873176
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 4 hrs
|
33.9625 percentage of saturation
Standard Deviation 22.445867
|
69.883333 percentage of saturation
Standard Deviation 16.560002
|
75.233333 percentage of saturation
Standard Deviation 19.819048
|
88.8 percentage of saturation
Standard Deviation 11.348128
|
102.83333 percentage of saturation
Standard Deviation 7.5210815
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 4.5 hrs
|
34.1 percentage of saturation
Standard Deviation 21.703917
|
64.6 percentage of saturation
Standard Deviation 12.73185
|
74.25 percentage of saturation
Standard Deviation 20.471614
|
88.24 percentage of saturation
Standard Deviation 13.994034
|
102.93333 percentage of saturation
Standard Deviation 10.715721
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 5 hrs
|
34.825 percentage of saturation
Standard Deviation 24.362251
|
66.8 percentage of saturation
Standard Deviation 16.702934
|
70.983333 percentage of saturation
Standard Deviation 19.212227
|
89.516667 percentage of saturation
Standard Deviation 12.587679
|
98.716667 percentage of saturation
Standard Deviation 9.4961922
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 6 hrs
|
32.75 percentage of saturation
Standard Deviation 21.835816
|
64 percentage of saturation
Standard Deviation 16.355427
|
64.116667 percentage of saturation
Standard Deviation 18.901896
|
74.133333 percentage of saturation
Standard Deviation 19.031938
|
93.966667 percentage of saturation
Standard Deviation 11.727688
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 7.5 hrs
|
29.375 percentage of saturation
Standard Deviation 24.115659
|
53.083333 percentage of saturation
Standard Deviation 16.412973
|
49.316667 percentage of saturation
Standard Deviation 16.104089
|
65.2 percentage of saturation
Standard Deviation 18.721218
|
80.483333 percentage of saturation
Standard Deviation 13.813532
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 8 hrs
|
25.38625 percentage of saturation
Standard Deviation 17.277825
|
49.183333 percentage of saturation
Standard Deviation 15.874182
|
44.9 percentage of saturation
Standard Deviation 17.190579
|
56.15 percentage of saturation
Standard Deviation 19.282298
|
74.316667 percentage of saturation
Standard Deviation 15.067902
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 9 hrs
|
23.18875 percentage of saturation
Standard Deviation 18.870984
|
41.866667 percentage of saturation
Standard Deviation 14.993421
|
35.533333 percentage of saturation
Standard Deviation 15.038972
|
50.483333 percentage of saturation
Standard Deviation 18.139506
|
65.816667 percentage of saturation
Standard Deviation 13.489613
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 10 hrs
|
19.4325 percentage of saturation
Standard Deviation 13.439108
|
34.466667 percentage of saturation
Standard Deviation 13.005794
|
27.416667 percentage of saturation
Standard Deviation 13.433453
|
40.133333 percentage of saturation
Standard Deviation 17.189842
|
55.366667 percentage of saturation
Standard Deviation 15.617127
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 12 hrs
|
16.518571 percentage of saturation
Standard Deviation 9.4347451
|
25.916667 percentage of saturation
Standard Deviation 9.637306
|
17.828333 percentage of saturation
Standard Deviation 11.615611
|
28.783333 percentage of saturation
Standard Deviation 13.911925
|
39.866667 percentage of saturation
Standard Deviation 13.873812
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 12.5 hrs
|
15.968571 percentage of saturation
Standard Deviation 9.7540546
|
24.566667 percentage of saturation
Standard Deviation 8.6832406
|
16.771667 percentage of saturation
Standard Deviation 11.701778
|
25.618333 percentage of saturation
Standard Deviation 12.537496
|
36.866667 percentage of saturation
Standard Deviation 14.673196
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 14 hrs
|
15.332857 percentage of saturation
Standard Deviation 7.8527208
|
22.483333 percentage of saturation
Standard Deviation 8.5307483
|
15.301667 percentage of saturation
Standard Deviation 8.8581091
|
21.486667 percentage of saturation
Standard Deviation 10.91862
|
28.716667 percentage of saturation
Standard Deviation 13.00514
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 16 hrs
|
13.305714 percentage of saturation
Standard Deviation 3.6857693
|
23.366667 percentage of saturation
Standard Deviation 10.372592
|
12.835 percentage of saturation
Standard Deviation 6.5323617
|
15.85 percentage of saturation
Standard Deviation 4.4440972
|
22.2 percentage of saturation
Standard Deviation 12.467879
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 20 hrs
|
14.835 percentage of saturation
Standard Deviation 4.4686303
|
25.916667 percentage of saturation
Standard Deviation 10.491981
|
12.386667 percentage of saturation
Standard Deviation 4.4342606
|
16.025 percentage of saturation
Standard Deviation 7.9655351
|
18.633333 percentage of saturation
Standard Deviation 10.414157
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 24 hrs
|
24.4125 percentage of saturation
Standard Deviation 10.022038
|
40 percentage of saturation
Standard Deviation 8.7824826
|
19 percentage of saturation
Standard Deviation 5.8845561
|
22.733333 percentage of saturation
Standard Deviation 8.7016474
|
24.483333 percentage of saturation
Standard Deviation 8.0759932
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 36 hrs
|
16.454286 percentage of saturation
Standard Deviation 5.1594536
|
19.883333 percentage of saturation
Standard Deviation 5.2162886
|
14.198333 percentage of saturation
Standard Deviation 6.6138655
|
17.441667 percentage of saturation
Standard Deviation 9.7067696
|
18.213333 percentage of saturation
Standard Deviation 5.4371561
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
t = 48 hrs
|
27.55 percentage of saturation
Standard Deviation 15.727683
|
40.533333 percentage of saturation
Standard Deviation 14.972864
|
29.383333 percentage of saturation
Standard Deviation 11.362291
|
31.766667 percentage of saturation
Standard Deviation 17.181928
|
41.58 percentage of saturation
Standard Deviation 8.2156558
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 0 hrs
|
30.95 percentage of saturation
Standard Deviation 3.2583227
|
26.5 percentage of saturation
Standard Deviation 10.784062
|
32.45 percentage of saturation
Standard Deviation 10.532379
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 16 hrs
|
18.833333 percentage of saturation
Standard Deviation 0.5507571
|
38.366667 percentage of saturation
Standard Deviation 13.245628
|
61.3 percentage of saturation
Standard Deviation 17.549473
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 18 hrs
|
18.766667 percentage of saturation
Standard Deviation 1.5821926
|
26.5 percentage of saturation
Standard Deviation 10.654201
|
43.433333 percentage of saturation
Standard Deviation 14.76383
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 0.5 hrs
|
31.55 percentage of saturation
Standard Deviation 4.2930176
|
32.6 percentage of saturation
Standard Deviation 11.667219
|
41.3 percentage of saturation
Standard Deviation 11.031591
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 1 hr
|
32.875 percentage of saturation
Standard Deviation 4.7422744
|
38.633333 percentage of saturation
Standard Deviation 11.449658
|
50.283333 percentage of saturation
Standard Deviation 10.526997
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 2 hrs
|
34.525 percentage of saturation
Standard Deviation 5.4267086
|
50 percentage of saturation
Standard Deviation 12.552928
|
67.266667 percentage of saturation
Standard Deviation 13.599069
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 4 hrs
|
38.95 percentage of saturation
Standard Deviation 7.485319
|
67.55 percentage of saturation
Standard Deviation 12.12151
|
92.833333 percentage of saturation
Standard Deviation 14.211498
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 6 hrs
|
40.625 percentage of saturation
Standard Deviation 11.092452
|
73.56 percentage of saturation
Standard Deviation 12.108179
|
108.86667 percentage of saturation
Standard Deviation 16.846325
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 9 hrs
|
31.925 percentage of saturation
Standard Deviation 12.673956
|
78.7 percentage of saturation
Standard Deviation 16.428025
|
107.55 percentage of saturation
Standard Deviation 6.8625797
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 12 hrs
|
23.7 percentage of saturation
Standard Deviation 7.7948701
|
78.816667 percentage of saturation
Standard Deviation 17.543935
|
104.9 percentage of saturation
Standard Deviation 10.529008
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 12.5 hrs
|
21.766667 percentage of saturation
Standard Deviation 6.7337459
|
71.483333 percentage of saturation
Standard Deviation 20.245238
|
100.31667 percentage of saturation
Standard Deviation 12.198429
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 14 hrs
|
20.333333 percentage of saturation
Standard Deviation 3.6855574
|
57.733333 percentage of saturation
Standard Deviation 15.467471
|
82.15 percentage of saturation
Standard Deviation 15.394902
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 20 hrs
|
22.133333 percentage of saturation
Standard Deviation 5.0895317
|
19.238333 percentage of saturation
Standard Deviation 7.7310036
|
29.966667 percentage of saturation
Standard Deviation 11.375178
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 24 hrs
|
30.766667 percentage of saturation
Standard Deviation 4.5763887
|
17.683333 percentage of saturation
Standard Deviation 4.5845029
|
22.783333 percentage of saturation
Standard Deviation 7.0024043
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 30 hrs
|
30.266667 percentage of saturation
Standard Deviation 11.83737
|
15.983333 percentage of saturation
Standard Deviation 3.8012717
|
18.45 percentage of saturation
Standard Deviation 5.9949145
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 36 hrs
|
20.7 percentage of saturation
Standard Deviation 7.2297994
|
13.403333 percentage of saturation
Standard Deviation 6.1446128
|
17.383333 percentage of saturation
Standard Deviation 8.9302669
|
—
|
—
|
—
|
—
|
—
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
t = 48 hrs
|
33.133333 percentage of saturation
Standard Deviation 3.1817186
|
32.44 percentage of saturation
Standard Deviation 17.400661
|
34.633333 percentage of saturation
Standard Deviation 12.038383
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
AUC 0 - 12
|
289 h*microgram/dL
Standard Deviation 235
|
334 h*microgram/dL
Standard Deviation 412
|
546 h*microgram/dL
Standard Deviation 312
|
890 h*microgram/dL
Standard Deviation 258
|
1420 h*microgram/dL
Standard Deviation 316
|
1590 h*microgram/dL
Standard Deviation 336
|
2210 h*microgram/dL
Standard Deviation 402
|
1770 h*microgram/dL
Standard Deviation 222
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
AUC 0 - 4
|
126 h*microgram/dL
Standard Deviation 103
|
107 h*microgram/dL
Standard Deviation 68.8
|
235 h*microgram/dL
Standard Deviation 104
|
329 h*microgram/dL
Standard Deviation 84.8
|
471 h*microgram/dL
Standard Deviation 97.7
|
305 h*microgram/dL
Standard Deviation 56
|
426 h*microgram/dL
Standard Deviation 151
|
590 h*microgram/dL
Standard Deviation 76.7
|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
AUC last
|
340 h*microgram/dL
Standard Deviation 206
|
277 h*microgram/dL
Standard Deviation 409
|
579 h*microgram/dL
Standard Deviation 265
|
903 h*microgram/dL
Standard Deviation 261
|
1460 h*microgram/dL
Standard Deviation 340
|
2070 h*microgram/dL
Standard Deviation 639
|
3000 h*microgram/dL
Standard Deviation 677
|
1820 h*microgram/dL
Standard Deviation 263
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
|
675 h*microgram/dL
Standard Deviation 270
|
1010 h*microgram/dL
Standard Deviation 190
|
1650 h*microgram/dL
Standard Deviation 172
|
2340 h*microgram/dL
Standard Deviation 565
|
3150 h*microgram/dL
Standard Deviation 657
|
1840 h*microgram/dL
Standard Deviation 263
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
|
4.06 dL/hour
Standard Deviation 1.2
|
5.11 dL/hour
Standard Deviation 0.99
|
4.59 dL/hour
Standard Deviation 0.464
|
6.72 dL/hour
Standard Deviation 1.63
|
6.61 dL/hour
Standard Deviation 1.5
|
5.56 dL/hour
Standard Deviation 0.938
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=8 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
|
62.6 microgram/dL
Standard Deviation 32.4
|
44.3 microgram/dL
Standard Deviation 34.8
|
113 microgram/dL
Standard Deviation 44.5
|
151 microgram/dL
Standard Deviation 33.9
|
228 microgram/dL
Standard Deviation 19.7
|
177 microgram/dL
Standard Deviation 38.2
|
251 microgram/dL
Standard Deviation 51.7
|
261 microgram/dL
Standard Deviation 30.3
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=12 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=4 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
|
4.5 hours
Interval 0.5 to 6.0
|
6 hours
Interval 4.0 to 6.0
|
4.5 hours
Interval 2.0 to 9.0
|
4.5 hours
Interval 4.0 to 4.5
|
4.75 hours
Interval 4.0 to 6.0
|
7.5 hours
Interval 6.0 to 12.0
|
6 hours
Interval 4.0 to 12.1
|
4.5 hours
Interval 4.0 to 4.5
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
|
45.3 micrograms/dL/mg
Standard Deviation 17.8
|
30.2 micrograms/dL/mg
Standard Deviation 6.78
|
30.4 micrograms/dL/mg
Standard Deviation 2.63
|
11.8 micrograms/dL/mg
Standard Deviation 2.55
|
12.5 micrograms/dL/mg
Standard Deviation 2.59
|
26.1 micrograms/dL/mg
Standard Deviation 3.03
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
|
0.544 1/hour
Standard Deviation 0.0788
|
0.668 1/hour
Standard Deviation 0.281
|
0.711 1/hour
Standard Deviation 0.423
|
0.475 1/hour
Standard Deviation 0.262
|
0.337 1/hour
Standard Deviation 0.114
|
0.917 1/hour
Standard Deviation 0.688
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
|
1.3 hours
Standard Deviation 0.187
|
1.19 hours
Standard Deviation 0.476
|
1.29 hours
Standard Deviation 0.721
|
1.87 hours
Standard Deviation 1.08
|
2.21 hours
Standard Deviation 0.549
|
1.04 hours
Standard Deviation 0.505
|
—
|
—
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.
Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP). There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Outcome measures
| Measure |
Cohorts 1 - 3, 6 Placebo
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
|
Cohort 1 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 6 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 Participants
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
|
7.65 dL
Standard Deviation 2.84
|
8.43 dL
Standard Deviation 2.94
|
8.59 dL
Standard Deviation 4.79
|
16.6 dL
Standard Deviation 6.33
|
20.8 dL
Standard Deviation 6.8
|
8.33 dL
Standard Deviation 4.05
|
—
|
—
|
Adverse Events
Cohorts 1 - 6 Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1 SFP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 SFP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 SFP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 SFP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5 SFP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 6 SFP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohorts 1 - 6 Placebo
n=12 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
|
Cohort 1 SFP
n=6 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
|
Cohort 2 SFP
n=6 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
|
Cohort 3 SFP
n=6 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
|
Cohort 4 SFP
n=6 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
|
Cohort 5 SFP
n=6 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
|
Cohort 6 SFP
n=6 participants at risk
A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
headache
|
0.00%
0/12
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
Vascular disorders
flushing
|
0.00%
0/12
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
dizziness
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
sensation of foreign body
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
infusion site pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
vessel puncture site hemorrhage
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
infusion site swelling
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
abdominal discomfort
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
diarrhoea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Reproductive system and breast disorders
dysmenorrhoea
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Senior Director, Clinical Research & Operations
Rockwell Medical
Phone: 248-960-9009
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60