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 range18 Years – 65 Years
SexALL
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
✕. 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.
✕
What they're measuring
1
Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax
. 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.