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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02564497

Enrollment

491

Registered

2015-09-30

Start date

2015-10-02

Completion date

2017-01-27

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Brief summary

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

Interventions

BIOLOGICALProcess E Belatacept

BIOLOGICALProcess C Belatacept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

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 -

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.	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)
Maximum Observed Serum Concentration (Cmax) of Belatacept	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

Measure	Time frame	Description
Total Body Clearance (CLT)	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.
Time of Maximum Observed Serum Concentration (Tmax)	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).
Half Life (T-HALF)	Day 1 to Day 71	—
Volume of Distribution at Steady State (Vss)	Day 1 to Day 71	—
Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)	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)

Countries

United States

Participant flow

Pre-assignment details

491 participants were enrolled; 146 were randomized and treated. 232 participants were enrolled but not randomized because they no longer met study criteria, 1 participant withdrew consent and 112 participants were not randomized for other reasons.

Participants by arm

Arm	Count
Process E Belatacept Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E	74
Process C Belatacept Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C	72
Total	146

Baseline characteristics

Characteristic	Process C Belatacept	Total	Process E Belatacept
Age, Continuous	35.4 years STANDARD_DEVIATION 10.48	34.5 years STANDARD_DEVIATION 10.05	33.6 years STANDARD_DEVIATION 9.6
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants	91 Participants	49 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants	55 Participants	25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Overall Participants American Indian or Alaskan Native	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Overall Participants Asian	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Overall Participants Black or African American	14 Participants	28 Participants	14 Participants
Race/Ethnicity, Customized Overall Participants Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Overall Participants Other	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Overall Participants White	56 Participants	114 Participants	58 Participants
Sex: Female, Male Female	31 Participants	68 Participants	37 Participants
Sex: Female, Male Male	41 Participants	78 Participants	37 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 74	0 / 72
other Total, other adverse events	25 / 74	27 / 72
serious Total, serious adverse events	0 / 74	1 / 72

Outcome results

Primary

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