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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564497
• Other study ID #: IM103-349
• Status: Completed
• Phase: Phase 1
• Start date: October 2, 2015
• Est. completion date: January 27, 2017

Study information

• Verified date: December 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: January 27, 2017
• Est. primary completion date: January 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Biological:
• Process E Belatacept

• Process C Belatacept

Locations

Country	Name	City	State
United States	PPD Development	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Day 1 to Day 71
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.	Day 1 to Day 71
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).	Day 1 to Day 71
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)	Day 1 to Day 71
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.	Day 1 to Day 71
Secondary	Volume of Distribution at Steady State (Vss)		Day 1 to Day 71
Secondary	Half Life (T-HALF)		Day 1 to Day 71

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