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

Phase 1

Completed

• Conditions: Renal Transplantation
• Interventions: Biological: Process E Belatacept; Biological: Process C Belatacept

• Registration Number: NCT02564497
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Study Start: 2015-10-02
• Primary Completion: 2017-01-27
• Study Completion: 2017-01-27
• Results First Submitted: 2018-01-22
• Status Verified: 2018-12
• Results First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-16
• Results First Posted: 2019-04-17
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 491

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

Read More

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 -

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Process E Belatacept	Process E Belatacept	Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E
Process C Belatacept	Process C Belatacept	Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C

Primary Outcome Measures

Name	Time	Method
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.
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)

Secondary Outcome Measures

Name	Time	Method
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)
Half Life (T-HALF)	Day 1 to Day 71
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).
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.
Volume of Distribution at Steady State (Vss)	Day 1 to Day 71

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States