Bioequivalence Study Assessing Iron Sucrose or Venofer® in Healthy Adult Subjects

NCT04155814 | Completed Phase 1 FDA Drug

• 2 other identifiers: BXU537298QSC202208
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the bioequivalence, pharmacokinetic (PK) profile, and safety and tolerability of Iron Sucrose (Test Product) relative to that of Venofer® in healthy subjects.

Conditions

Bioequivalance

Outcome Measures

Primary Outcomes (2)

• Cmax(delta)

  Maximum concentration (Cmax) across all time points for the delta difference between Total Iron (TI) and Transferrin Bound Iron (TBI). This is a PK test parameter to compare bioequivalence of two drug products.

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

• AUC0-t(delta)

  Area under the concentration curve (AUC) from time zero to last time of quantifiable concentration (Tlast) for the delta difference in AUC0-t between TI and TBI. This is a PK test parameter to compare bioequivalence of two plasma drug products.

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

Secondary Outcomes (13)

• Cmax

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

• AUC0-t

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

• AUC0-inf

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

• Tmax

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

• t1/2

  Hours before injection (24, 12, 0.25); Minutes after end of injection (1, 5, 10, 15, 30, 45); Hours after end of injection (1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36)

Study Arms (2)

Iron Sucrose Injection

EXPERIMENTAL

IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours.

Drug: Iron Sucrose Injection

Venofer Injection

ACTIVE COMPARATOR

IV injection (5 mL), delivered over 5 minutes to subjects that have been fasted for a minimum of 10 hours.

Drug: Venofer Injection

Interventions

Iron Sucrose Injection DRUG

USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength

Iron Sucrose Injection

Venofer Injection DRUG

(Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength

Venofer Injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or non-pregnant, non-lactating healthy females
• Age 18 to 55 years of age (both inclusive)
• Must, in the opinion of the investigator, be in good health based upon medical history, physical examination (including vital signs and ECGs) and clinical laboratory tests assessed at the time of screening
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 and a minimum body weight of 40 kg, or if outside the range, considered not clinically significant by the investigator
• Ferritin levels not less than the lower limit of normal as defined by clinical laboratory reference ranges for female and male subjects at screening only
• Transferrin Saturation (TSAT) not less than the lower limit of normal as defined by clinical laboratory reference ranges for female and male subjects at screening only
• Hemoglobin levels not less than the lower limit of normal as defined by clinical laboratory reference ranges for male and female subjects
• Must agree to use an adequate method of contraception:
• For male subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence. Subjects should also not donate sperm during this time.
• For female subjects: Female subjects of childbearing potential, defined as a woman \< 55 years of age who has not had a partial or full hysterectomy or oophorectomy, must have a negative urine pregnancy test at screening and a negative beta human chorionic gonadotropin (β-hCG) pregnancy test at admission. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study
• Non-smoker, defined as: Non-smoker for \> 12 months (i.e., subject has not smoked or used any tobacco product, e-cigarettes, and nicotine replacement products for the 12 months prior to the start of the study) based on subject report.
• Must be willing and able to comply with all study requirements
• Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures

You may not qualify if:

• Hypersensitivity to iron sucrose or iron products
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
• History of iron deficiency within 6 months prior to screening
• History of anemia within 6 months prior to screening
• Suspicion of iron overload as evidenced by both elevated serum TSAT and serum ferritin levels
• History of hemochromatosis
• Bleeding disorders, acute bleeding or recently documented hemorrhage
• Females with history of hypermenorrhea or menorrhagia
• History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, as judged by the investigator
• Must not have significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria
• Female subjects who are currently pregnant, lactating, or planning to become pregnant during the study period
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• Positive drugs of abuse test result or history of drug abuse in the past 6 months based on subject report

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Quotient Sciences: collaborator

Study Sites (1)

Baxter Investigational Site

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: September 19, 2019
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

US (1)