- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767128
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol (Ferrous Sulfate) and Triferic (Ferric Pyrophosphate Citrate) Administered Orally With Shohl's Solution in Healthy Volunteers
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Kalamazoo, Michigan, United States, 49071
- Jasper Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fer-In-Sol Orally
Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
|
Other Names:
|
EXPERIMENTAL: Shohl's solution followed by Fer-In-Sol Orally
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.
|
Other Names:
Other Names:
|
EXPERIMENTAL: Triferic Orally
Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw.
|
Other Names:
|
EXPERIMENTAL: Shohl's solution followed by Triferic Orally
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.
|
Other Names:
Other Names:
|
EXPERIMENTAL: Shohl's solution followed immediately by Triferic
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.
|
Other Names:
Other Names:
|
EXPERIMENTAL: Triferic via IV
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.
|
Other Names:
|
NO_INTERVENTION: Baseline
baseline serum iron profile will be determined for each patient.
no study drug will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0, 1, 2, 4, 6, 8, 12, 16, and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: 13 days
|
The number of participants in each treatment group who experienced treatment emergent adverse events will be quantified.
|
13 days
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: 13 days
|
The number of participants in each treatment group who experienced treatment emergent serious adverse events will be quantified.
|
13 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMFPC-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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