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CompletedNCT02564497Updated Apr 17, 2019Results posted

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

A Phase 1 interventional study of Process E Belatacept and Process C Belatacept in Renal Transplantation, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
491
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Renal Transplantation
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. History of TB, malignancy, any other chronic or acute infecton or disease.
  2. History of acute or chronic medical illness
  3. 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.
  4. History of allergy to belatacept or related compounds -
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
491 participants (actual)

Study arms

  • Other
    Process E Belatacept

    Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E

    Biological: Process E Belatacept

  • Other
    Process C Belatacept

    Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C

    Biological: Process C Belatacept

Interventions

  • BiologicalProcess E Belatacept
  • BiologicalProcess C Belatacept
06

What researchers measure

Primary outcomes

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

    (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)

    Time frame: Day 1 to Day 71

  2. Maximum Observed Serum Concentration (Cmax) of Belatacept

    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.

    Time frame: Day 1 to Day 71

Secondary outcomes

  1. Time of Maximum Observed Serum Concentration (Tmax)

    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).

    Time frame: Day 1 to Day 71

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

    (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)

    Time frame: Day 1 to Day 71

  3. Total Body Clearance (CLT)

    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.

    Time frame: Day 1 to Day 71

  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

07

Results

Posted Apr 17, 2019

Participant flow

Participant flow — Overall Study
MilestoneProcess E BelataceptProcess C Belatacept
Started7472
Completed7472
Not completed00

Outcome measures

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

(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)

Time frame:
Day 1 to Day 71
Reported as:
Geometric mean · ng.h/mL
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.
ng.h/mLProcess E BelataceptProcess C Belatacept
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.17084539 ± 1721579398 ± 17
PrimaryMaximum Observed Serum Concentration (Cmax) of Belatacept

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.

Time frame:
Day 1 to Day 71
Reported as:
Geometric mean · ng/mL
Maximum Observed Serum Concentration (Cmax) of Belatacept
ng/mLProcess E BelataceptProcess C Belatacept
Maximum Observed Serum Concentration (Cmax) of Belatacept269305 ± 16255169 ± 16
SecondaryTime of Maximum Observed Serum Concentration (Tmax)

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).

Time frame:
Day 1 to Day 71
Reported as:
Median · h
Time of Maximum Observed Serum Concentration (Tmax)
hProcess E BelataceptProcess C Belatacept
Time of Maximum Observed Serum Concentration (Tmax)1.00 (0.467 to 2.00)1.00 (0.467 to 2.00)
SecondaryArea Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)

(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)

Time frame:
Day 1 to Day 71
Reported as:
Geometric mean · ng.h/mL
Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)
ng.h/mLProcess E BelataceptProcess C Belatacept
Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)17020284 ± 1621422168 ± 16
SecondaryTotal Body Clearance (CLT)

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.

Time frame:
Day 1 to Day 71
Reported as:
Geometric mean · L/h
Total Body Clearance (CLT)
L/hProcess E BelataceptProcess C Belatacept
Total Body Clearance (CLT)0.0433 ± 180.0343 ± 19
SecondaryVolume of Distribution at Steady State (Vss)
Time frame:
Day 1 to Day 71
Reported as:
Geometric mean · L
Volume of Distribution at Steady State (Vss)
LProcess E BelataceptProcess C Belatacept
Volume of Distribution at Steady State (Vss)7.89 ± 157.35 ± 19
SecondaryHalf Life (T-HALF)
Time frame:
Day 1 to Day 71
Reported as:
Mean · h
Half Life (T-HALF)
hProcess E BelataceptProcess C Belatacept
Half Life (T-HALF)160 ± 39.5183 ± 47.7

Adverse events

Collected over From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Belatacept Process E0/74 (0%)0/74 (0%)25/74 (33.8%)
Belatacept Process C0/72 (0%)1/72 (1.4%)27/72 (37.5%)
Most frequent serious events
Most frequent serious events
EventBelatacept Process EBelatacept Process C
Nasal injuryInjury, poisoning and procedural complications0/741/72
Most frequent other events
Most frequent other events
EventBelatacept Process EBelatacept Process C
HeadacheNervous system disorders11/7421/72
Upper respiratory tract infectionInfections and infestations2/746/72
NasopharyngitisInfections and infestations6/740/72
NauseaGastrointestinal disorders1/744/72
Oropharyngeal painRespiratory, thoracic and mediastinal disorders4/744/72
Nasal congestionRespiratory, thoracic and mediastinal disorders4/742/72
RhinorrhoeaRespiratory, thoracic and mediastinal disorders4/742/72

Baseline characteristics

Age, Continuous
Age, Continuous(years)Process E BelataceptProcess C BelataceptTotal
Mean33.6 ± 9.6035.4 ± 10.4834.5 ± 10.05
Sex: Female, Male
Sex: Female, Male(Participants)Process E BelataceptProcess C BelataceptTotal
Female373168
Male374178
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Process E BelataceptProcess C BelataceptTotal
Hispanic or Latino494291
Not Hispanic or Latino253055
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Process E BelataceptProcess C BelataceptTotal
Overall Participants — White5856114
Overall Participants — Black or African American141428
Overall Participants — American Indian or Alaskan Native101
Overall Participants — Asian011
Overall Participants — Native Hawaiian or Other Pacific Islander011
Overall Participants — Other101
08

Study locations

1 site
  • PPD Development
    Austin, Texas, United States
09

References and documents

Study documents

  • Study protocol · Sep 27, 2016
  • Statistical analysis plan · Jan 18, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02564497
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 30, 2015
Start date
Oct 2, 2015
Primary completion
Jan 27, 2017
Completion
Jan 27, 2017
Results posted
Apr 17, 2019
Last update
Apr 17, 2019

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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