A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia

NCT03399084 | Completed Phase 1 FDA Drug

• 1 other identifier: 1637 FCM_1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate bioequivalence of two formulations of Ferric Carboxymaltose as measured by serum total iron, in adult patients with iron deficiency anemia.

Conditions

Iron Deficiency Anemia

Keywords

Ferric carboxymaltose; Anemia

Outcome Measures

Primary Outcomes (2)

• Bioequivalence assessed by maximum serum concentration (Cmax)of serum total iron.

  Measured by Cmax - The maximum plasma concentration of iron

  Up to 7 days

• Bioequivalence assessed by area under the serum concentration-time curve (AUC) of serum total iron.

  Plasma Pharmacokinetics (PK) of study medication: Area Under the Plasma Concentration-time Curve (AUC)

  Up to 7 Days

Secondary Outcomes (8)

• Maximum serum concentration (Cmax) of serum transferrin-bound iron.

  Up to 7 days

• Time of Cmax (Tmax) of serum total iron and transferrin-bound iron

  Up to 7 Days

• Area under the serum concentration-time curve (AUC) of serum transferrin-bound iron

  Up to 7 Days

• Apparent terminal rate constant of serum total iron and transferrin-bound iron

  Up to 7 Days

• Apparent terminal half-life of serum total iron and transferrin-bound iron

  Up to 7 Days

Study Arms (2)

Ferric carboxymaltose (test)

EXPERIMENTAL

Patients will receive a single dose of Ferric carboxymaltose

Drug: Ferric carboxymaltose

Ferric carboxymaltose (reference)

ACTIVE COMPARATOR

Patients will receive a single dose of Ferric carboxymaltose

Drug: Ferric carboxymaltose

Interventions

Ferric carboxymaltose DRUG

750 mg/15 mL

Ferric carboxymaltose (reference); Ferric carboxymaltose (test)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients at least 18 - 65 years of age;
• Patients with a body mass index (BMI) between 18.5 - 35 and with a body weight of ≥50 kg - ≤130 kg;

You may not qualify if:

• Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product
• Patients with chronic kidney disease who are on dialysis of any kind.
• If female, is pregnant or nursing.
• Patients with blood loss leading to hemodynamic instability
• Patients with recent parenteral iron within 3 months prior to screening.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigative Site

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Anemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sandoz Sandoz

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: January 16, 2018
• Study Start: November 29, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)