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OpenTrials
Completed

NCT Number: NCT03375138

A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Clinic, Austin, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed informed consent form.
  • Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
  • Weight between 60.0 to 100.0 kg, inclusive.
  • Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.
  • Women must not be breastfeeding.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.

Exclusion criteria

  • Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
  • History of shingles (herpes zoster).
  • Personal or strong family history of cancer.
  • Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
  • Any known or suspected autoimmune disorder.

Other protocol defined inclusion/exclusion criteria could apply.

Treatment and study plan

Belatacept

Drug

Specified dose on specified days

Primary outcomes

  1. Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).

    Time frame: Up to day 57

    Measured by plasma concentration.

  2. Maximum observed serum concentration (Cmax).

    Time frame: Up to day 57

    Measured by plasma concentration.

Secondary outcomes

  1. Incidence of non-serious Adverse Events (AEs).

    Time frame: Up to 71 days.

    Safety and tolerability as measured by incidence of non-serious AEs.

  2. Incidence of Serious Adverse Events (SAEs).

    Time frame: Up to 71 days.

    Safety and tolerability as measured by incidence of SAEs.

  3. Incidence of Adverse Events (AEs) leading to discontinuation.

    Time frame: Up to 71 days.

    Safety and tolerability as measured by incidence of AEs leading to discontinuation.

  4. Number of participants with vital sign abnormalities.

    Time frame: Up to 71 days.

  5. Number of participants with physical examination abnormalities.

    Time frame: Up to 71 days.

  6. Number of participants with clinical laboratory abnormalities.

    Time frame: Up to 71 days.

  7. Number of participants with electrocardiogram (ECG) abnormalities.

    Time frame: Up to 71 days.

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 PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Jul 24, 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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