Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With… (NCT02767128) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
United States14 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax
. 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.