Iron-refractory, Iron-deficiency Anemia (IRIDA)Phase 1NCT02767128

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

A Phase 1 study testing Triferic, Fer-In-Sol and Shohl's solution in people with Iron-refractory, Iron-deficiency Anemia (IRIDA), run by Rockwell Medical Technologies, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Iron-refractory, Iron-deficiency Anemia (IRIDA)
What is being tested?: Triferic, Fer-In-Sol and Shohl's solution
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Apr 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The patient must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures.
The patient has hemoglobin, MCV and reticulocyte values within the reference range for gender. (Male: Hgb ≥13.0 g/dL; Female Hgb ≥ 12.0 g/dL) at Screening.
The patient must have transferrin saturation (TSAT) of ≥20% at Screening.
The patient must have a total iron binding capacity (TIBC) of ≥250 ug/dL at Screening.
The patient must have a serum ferritin within the following reference range for gender at Screening: (Males: 23-336 ng/mL; Females: 11-306 ng/mL).
The patient must agree to discontinue all iron preparations for 14 days prior to Baseline.

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If the patient is female, she must be non-pregnant and non-lactating, and be at least 90 days post-partum (if applicable) at Screening. Women of childbearing potential must be willing to use appropriate birth control during the entire duration of the study.
The patient must be willing and able to comply with all study procedures and restrictions.
The patient must have no clinically significant abnormal findings on medical history, vital signs, physical examination, or clinical laboratory results during Screening.
The patient must have a body mass index (BMI) of ≤35.0 kg/m2 at Screening.

Who cannot join

The patient has had administration of oral iron supplements within 14 days prior to Baseline.
The patient has received IV iron within 6 months prior to Screening.
The patient has a serum CRP concentration above the upper limit of normal at Screening or Baseline (> 6.0 mg/L).
The patient has concurrent or recurrent disease (e.g., cardiovascular, renal, hepatic, gastrointestinal, malignant, etc.) that could affect the action or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
The patient has an acute illness within 14 days prior to Baseline.
The patient is currently using any medication (including prescription, over-the-counter (OTC), herbal, or homeopathic preparations) within 14 days prior to Baseline. Exceptions are contraceptives, hormone replacement therapy, acetaminophen, and non-steroidal anti-inflammatory drugs.

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The patient has known or suspected intolerance or hypersensitivity to iron-containing products.
The patient has a history of alcohol or substance abuse within the past year.
The patient has a positive screen for cotinine or drugs of abuse.
The patient is positive for HIV, hepatitis B, or hepatitis C by history.
The patient donated blood or blood products (e.g., plasma or platelets) within 30 days prior to Screening.
The patient has participated in an investigational drug study within 30 days prior to Screening.
The patient is pregnant or intends to become pregnant before completing the study.
The patient's current medical status, in the investigator's opinion, would preclude participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Jasper Clinic
Kalamazoo, Michigan, 49071

Other trials in United States

About this study

Official title: Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol (Ferrous Sulfate) and Triferic (Ferric Pyrophosphate Citrate) Administered Orally With Shohl's Solution in Healthy Volunteers

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.

Read the detailed description

This is a Phase 1/2, randomized multiple treatments, single dose study assessing the pharmacokinetics (PK) and absolute bioavailability of Fer-In-Sol ( Ferrous Sulfate) and Triferic (ferric pyrophosphate citrate, or FPC) administered orally with Shohl's solution in healthy volunteers.

Total participation in the study is approximately six weeks and is comprised of a screening visit, 6 treatment periods, and a follow-up visit.

The study will be conducted over a 13 day period:

Day 1 will used to determine the baseline serum iron profile for each subject.

Each subject will subsequently receive in a randomized sequence between Day 2 and 10:

A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw
a single oral dose of Triferic PO at 3 mg Fe/kg bw
a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.

All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic the 4 hour iron tolerance test) on Day 12.

Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Conditions: Iron-refractory, Iron-deficiency Anemia (IRIDA)
Being tested: Triferic, Fer-In-Sol, Shohl's solution
Keywords: pharmacokinetics, healthy adult volunteer
Medical subject headings: Iron-Refractory Iron Deficiency Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrifericDrug
Also called ferric pyrophosphate citrate, FPC
Fer-In-SolDrug
Also called Ferrous Sulfate
Shohl's solutionDrug
Also called Oracit

Study groups in NCT02767128
Study group	Role	What they receive
Fer-In-Sol Orally	Experimental	Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw). Receives: Drug: Fer-In-Sol
Shohl's solution followed by Fer-In-Sol Orally	Experimental	Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw. Receives: Drug: Fer-In-Sol; Drug: Shohl's solution
Triferic Orally	Experimental	Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw. Receives: Drug: Triferic
Shohl's solution followed by Triferic Orally	Experimental	Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw. Receives: Drug: Triferic; Drug: Shohl's solution
Shohl's solution followed immediately by Triferic	Experimental	Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw. Receives: Drug: Triferic; Drug: Shohl's solution
Triferic via IV	Experimental	Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours. Receives: Drug: Triferic
Baseline	No intervention	baseline serum iron profile will be determined for each patient. no study drug will be administered.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax
The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)
Measured: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours

Secondary outcomes (2)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
The number of participants in each treatment group who experienced treatment emergent adverse events will be quantified.
Measured: 13 days
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
The number of participants in each treatment group who experienced treatment emergent serious adverse events will be quantified.
Measured: 13 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Apr 2016

First posted10 May 2016 (estimated)
Study startApr 2016
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Iron-refractory, Iron-deficiency Anemia (IRIDA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02767128
Sponsor's protocol ID: RMFPC-18
Status last verified: Aug 2018
First submitted: 5 May 2016
Last updated: 1 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol (Ferrous Sulfate) and Triferic (Ferric Pyrophosphate Citrate) Administered Orally With Shohl's Solution in Healthy Volunteers
ClinicalTrials.gov ID: NCT02767128
Acronym / sponsor ID: RMFPC-18
Conditions: Iron-refractory, Iron-deficiency Anemia (IRIDA)
Keywords: pharmacokinetics, healthy adult volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 10 May 2016 (estimated)
Results: Posted 1 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.

Detailed description

Total participation in the study is approximately six weeks and is comprised of a screening visit, 6 treatment periods, and a follow-up visit.

The study will be conducted over a 13 day period:

Day 1 will used to determine the baseline serum iron profile for each subject.

Each subject will subsequently receive in a randomized sequence between Day 2 and 10:

A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw
a single oral dose of Triferic PO at 3 mg Fe/kg bw
a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.

All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic the 4 hour iron tolerance test) on Day 12.

Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Fer-In-Sol Orally	Experimental	Drug: Fer-In-SolPatients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
Shohl's solution followed by Fer-In-Sol Orally	Experimental	Drug: Fer-In-Sol, Drug: Shohl's solutionPatients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw.
Triferic Orally	Experimental	Drug: TrifericPatients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.
Shohl's solution followed by Triferic Orally	Experimental	Drug: Triferic, Drug: Shohl's solutionPatients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
Shohl's solution followed immediately by Triferic	Experimental	Drug: Triferic, Drug: Shohl's solutionPatients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.
Triferic via IV	Experimental	Drug: TrifericPatients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours.
Baseline	No intervention	–baseline serum iron profile will be determined for each patient. no study drug will be administered.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The patient must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures.
The patient has hemoglobin, MCV and reticulocyte values within the reference range for gender. (Male: Hgb ≥13.0 g/dL; Female Hgb ≥ 12.0 g/dL) at Screening.
The patient must have transferrin saturation (TSAT) of ≥20% at Screening.
The patient must have a total iron binding capacity (TIBC) of ≥250 ug/dL at Screening.
The patient must have a serum ferritin within the following reference range for gender at Screening: (Males: 23-336 ng/mL; Females: 11-306 ng/mL).

Key exclusion criteria (14 listed)

The patient has had administration of oral iron supplements within 14 days prior to Baseline.
The patient has received IV iron within 6 months prior to Screening.
The patient has a serum CRP concentration above the upper limit of normal at Screening or Baseline (> 6.0 mg/L).
The patient has concurrent or recurrent disease (e.g., cardiovascular, renal, hepatic, gastrointestinal, malignant, etc.) that could affect the action or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
The patient has an acute illness within 14 days prior to Baseline.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TrifericAlso: ferric pyrophosphate citrate, FPC	Drug	Shohl's solution followed by Triferic Orally, Shohl's solution followed immediately by Triferic, Triferic Orally, Triferic via IV
Fer-In-SolAlso: Ferrous Sulfate	Drug	Fer-In-Sol Orally, Shohl's solution followed by Fer-In-Sol Orally
Shohl's solutionAlso: Oracit	Drug	Shohl's solution followed by Fer-In-Sol Orally, Shohl's solution followed by Triferic Orally, Shohl's solution followed immediately by Triferic

Primary outcome

Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax
Time frame: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours
The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)

2 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 13 days
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: 13 days

Results and safety

Results posted to the registry on 1 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	14	14

Primary outcome: Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax

Time frame: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours. Geometric mean (Geometric Coefficient of Variation). Unit: microgram/deciliter

Measure	Treatment A n = 14	Treatment B n = 13	Treatment C n = 7	Treatment D n = 11	Treatment E n = 10	Treatment F n = 13
Value	140 (39.4)	62.0 (78.7)	32.4 (93.9)	51.9 (82.2)	52.0 (71.8)	100 (91.5)

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fer-In-Sol Orally	0 of 14 (0%)	7 of 14 (50%)	0 of 14
Shohl's Solution Followed by Fer-In-Sol Orally	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14
Triferic Orally	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Shohl's Solution Followed by Triferic Orally	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Shohl's Solution Followed Immediately by Triferic	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Triferic Via IV	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond D Pratt, MD, FACP study director

Rockwell Medical, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax (time frame: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.