Clinical trial NCT03375138: A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).
timeFrame: Up to day 57
measure: Maximum observed serum concentration (Cmax).
timeFrame: Up to day 57
Secondary outcomes:
measure: Incidence of non-serious Adverse Events (AEs).
timeFrame: Up to 71 days.
measure: Incidence of Serious Adverse Events (SAEs).
timeFrame: Up to 71 days.
measure: Incidence of Adverse Events (AEs) leading to discontinuation.
timeFrame: Up to 71 days.
measure: Number of participants with vital sign abnormalities.
timeFrame: Up to 71 days.
measure: Number of participants with physical examination abnormalities.
timeFrame: Up to 71 days.
measure: Number of participants with clinical laboratory abnormalities.
timeFrame: Up to 71 days.
measure: Number of participants with electrocardiogram (ECG) abnormalities.
timeFrame: Up to 71 days.
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Austin Clinic
state: Texas
city: Dallas
country: United States
facility: Covance, Inc.
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: