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

NCT02564497 | Completed Phase 1 Results

• 1 other identifier: IM103-349
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Time of Maximum Observed Serum Concentration (Tmax)

  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

• Total Body Clearance (CLT)

  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

Study Arms (2)

Process E Belatacept

OTHER

Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E

Biological: Process E Belatacept

Process C Belatacept

OTHER

Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C

Biological: Process C Belatacept

Interventions

Process E Belatacept BIOLOGICAL

Process E Belatacept

Process C Belatacept BIOLOGICAL

Process C Belatacept

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent
• Target population: Healthy males and females.
• Males and females, ages 18 to 55 years, inclusive.
• Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
• Women must not be breastfeeding
• Men and WOCBP must agree to follow instructions for contraception

You may not qualify if:

• History of TB, malignancy, any other chronic or acute infecton or disease.
• History of acute or chronic medical illness
• 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.
• History of allergy to belatacept or related compounds -

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development

Austin, Texas, United States

Location

Related Links

• BMS Clinical Trial Education Resource
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: September 30, 2015
• Study Start: October 2, 2015
• Primary Completion: January 27, 2017
• Study Completion: January 27, 2017
• Last Updated: April 17, 2019
• Results First Posted: April 17, 2019

Record last verified: 2018-12

Locations

US (1)