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Completed

NCT Number: NCT02564497

A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C

The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects

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Key information

Conditions

Renal Transplantation

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • Target population: Healthy males and females.
  • Males and females, ages 18 to 55 years, inclusive.
  • Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
  • Women must not be breastfeeding
  • Men and WOCBP must agree to follow instructions for contraception

Exclusion criteria

  • History of TB, malignancy, any other chronic or acute infecton or disease.
  • History of acute or chronic medical illness
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
  • History of allergy to belatacept or related compounds -

Treatment and study plan

Process E Belatacept

Biological

Process C Belatacept

Biological

Primary outcomes

  1. Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.

    Time frame: Day 1 to Day 71

    (AUC[INF]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng*h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)

  2. Maximum Observed Serum Concentration (Cmax) of Belatacept

    Time frame: Day 1 to Day 71

    Cmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in nanograms per milliliter.

Secondary outcomes

  1. Time of Maximum Observed Serum Concentration (Tmax)

    Time frame: Day 1 to Day 71

    Tmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Tmax was measured in hours (h).

  2. Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)

    Time frame: Day 1 to Day 71

    (AUC[0-T]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng.h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)

  3. Total Body Clearance (CLT)

    Time frame: Day 1 to Day 71

    CLT was the volume of belatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). CLT was measured in liters per hour.

  4. Volume of Distribution at Steady State (Vss)

    Time frame: Day 1 to Day 71

  5. Half Life (T-HALF)

    Time frame: Day 1 to Day 71

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Subjects

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2015
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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