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The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Process E Belatacept | Other | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E |
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| Process C Belatacept | Other | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Process E Belatacept | Biological |
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| Process C Belatacept |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 to Day 71 |
| 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. | Day 1 to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development | Austin | Texas | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Process E Belatacept | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E |
| FG001 | Process C Belatacept | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2016 | Jan 22, 2018 |
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| Biological |
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(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) |
| Day 1 to Day 71 |
| 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. | Day 1 to Day 71 |
| Volume of Distribution at Steady State (Vss) | Day 1 to Day 71 |
| Half Life (T-HALF) | Day 1 to Day 71 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Process E Belatacept | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E |
| BG001 | Process C Belatacept | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | All randomized, treated participants with evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng.h/mL | Day 1 to Day 71 |
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| Primary | 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. | All randomized, treated participants with evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 to Day 71 |
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| Secondary | 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). | All randomized, treated participants with evaluable PK data | Posted | Median | 90% Confidence Interval | h | Day 1 to Day 71 |
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| Secondary | 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) | All randomized, treated participants with evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng.h/mL | Day 1 to Day 71 |
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| Secondary | 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. | All randomized, treated participants with evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 1 to Day 71 |
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| Secondary | Volume of Distribution at Steady State (Vss) | All randomized, treated participants with evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Day 1 to Day 71 |
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| Secondary | Half Life (T-HALF) | All randomized, treated participants with evaluable PK data | Posted | Mean | Standard Deviation | h | Day 1 to Day 71 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belatacept Process E | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E | 0 | 74 | 0 | 74 | 25 | 74 |
| EG001 | Belatacept Process C | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C | 0 | 72 | 1 | 72 | 27 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email: | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2017 | Jan 22, 2018 | SAP_001.pdf |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| American Indian or Alaskan Native |
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| Native Hawaiian or Other Pacific Islander |
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