Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C (NCT NCT02564497)
NCT ID: NCT02564497
Last Updated: 2019-04-17
Results Overview
(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)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
491 participants
Primary outcome timeframe
Day 1 to Day 71
Results posted on
2019-04-17
Participant Flow
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.
Participant milestones
| Measure |
Process E Belatacept
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
72
|
|
Overall Study
COMPLETED
|
74
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
Baseline characteristics by cohort
| Measure |
Process E Belatacept
n=74 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
34.5 years
STANDARD_DEVIATION 10.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Overall Participants · White
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Overall Participants · Black or African American
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Overall Participants · American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Overall Participants · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Overall Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Overall Participants · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
(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)
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.
|
17084539 ng.h/mL
Geometric Coefficient of Variation 17
|
21579398 ng.h/mL
Geometric Coefficient of Variation 17
|
PRIMARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
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.
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of Belatacept
|
269305 ng/mL
Geometric Coefficient of Variation 16
|
255169 ng/mL
Geometric Coefficient of Variation 16
|
SECONDARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
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).
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax)
|
1.00 h
Interval 0.467 to 2.0
|
1.00 h
Interval 0.467 to 2.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
(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)
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)
|
17020284 ng.h/mL
Geometric Coefficient of Variation 16
|
21422168 ng.h/mL
Geometric Coefficient of Variation 16
|
SECONDARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
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.
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Total Body Clearance (CLT)
|
0.0433 L/h
Geometric Coefficient of Variation 18
|
0.0343 L/h
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
7.89 L
Geometric Coefficient of Variation 15
|
7.35 L
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Day 1 to Day 71Population: All randomized, treated participants with evaluable PK data
Outcome measures
| Measure |
Process E Belatacept
n=73 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Process C Belatacept
n=72 Participants
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Half Life (T-HALF)
|
160 h
Standard Deviation 39.5
|
183 h
Standard Deviation 47.7
|
Adverse Events
Belatacept Process E
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Belatacept Process C
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belatacept Process E
n=74 participants at risk
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Belatacept Process C
n=72 participants at risk
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
1.4%
1/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
Other adverse events
| Measure |
Belatacept Process E
n=74 participants at risk
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
|
Belatacept Process C
n=72 participants at risk
Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
5.6%
4/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
6/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
0.00%
0/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
2/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
8.3%
6/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
|
Nervous system disorders
Headache
|
14.9%
11/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
29.2%
21/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.4%
4/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
2.8%
2/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.4%
4/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
5.6%
4/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.4%
4/74 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
2.8%
2/72 • From initiation of study drug to 101 days of dosing discontinuation (assessed up to March 2017, approximately 16 months)
The collection of nonserious AE information began at initiation of the study drug, and continued until Day 71. Monitoring of SAEs began from the date of the subject's written consent to participate in the study until Day 101. Nonserious AEs were followed to resolution or stabilization or reported as SAEs if they became serious. All SAEs that occurred with 101 days of dosing discontinuation were collected.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER