A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects

NCT03398473 | Completed Phase 1 FDA Drug

• 1 other identifier: C3461009
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.

Conditions

Healthy

Keywords

Epoetin Hospira; Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Maximum serum concentration (C max) of PF-06946151 SDV

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

• Maximum serum concentration (C max) of PF-06946151 MDV

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

• Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

• Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

• Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

• Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]

Secondary Outcomes (10)

• Time to reach maximum concentration (T max) of PF-06946151 SDV

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]

• Time to reach maximum concentration (T max) of PF-06946151 MDV

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]

• Elimination half life (T 1/2) of PF-06946151 SDV

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]

• Elimination half life (T 1/2) of PF-06946151 MDV

  [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]

• Number of subjects with adverse events (AEs) by severity and relationship to treatment

  Day 1 through approximately Day 30 after Period 2

Study Arms (2)

Epoetin Hospira SDV

EXPERIMENTAL

Epoetin Hospira Single Dose Vial (SDV)

Drug: Epoetin Hospira SDV

Epoetin Hospira MDV

EXPERIMENTAL

Epoetin Hospira Multi-Dose Vial (MDV)

Drug: Epoetin Hospira MDV

Interventions

Epoetin Hospira SDV DRUG

Epoetin Hospira Single Dose Vial

Epoetin Hospira SDV

Epoetin Hospira MDV DRUG

Epoetin Hospira Multi-Dose Vial

Epoetin Hospira MDV

Eligibility Criteria

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

You may qualify if:

• Healthy female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead electrocardiogram, or clinical laboratory tests.
• Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
• Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.
• Have undergone a documented hysterectomy and/or bilateral oophorectomy;
• Have medically confirmed ovarian failure.
• Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), cancer, (except for basal cell carcinoma of skin), erythrocytosis, or seizures.
• Any condition possibly affecting drug absorption (e.g. gastrectomy).
• History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
• A positive urine drug screen.
• Use of tobacco or nicotine-containing products within 3 months of Screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).
• Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including benzyl alcohol and any other related drugs).
• Any previous use of epoetin.
• History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 oz. \[150 mL\] of wine or as oz. \[360 mL\] of beer or 1.5 oz. \[45 mL\] of hard liquor) within 6 months before Screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceeding the fits dose of investigational product (whichever is longer).
• Screening supine BP \>= 140 mmHg (systolic) or \>=90 mmHg (Diastolic), following at least 5 minutes of supine rest. If BP \>= 140 mmHg (systolic) or \>= 90 mmHg (Diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
• Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval\> 450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
• Subject's with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
• Aspartate aminotransferase (AST) OR alanine aminotransferase (ALT) leve l\>= 1.5 X upper limit of normal (ULN);
• Total bilirubin level 1.5 X ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= ULN.
• Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outline in the protocol for the duration of the study and for at least 30 days after the last dose of investigational product.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 12, 2018
• Study Start: January 25, 2018
• Primary Completion: April 11, 2018
• Study Completion: May 7, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)