A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

Healthy Volunteers 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 PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375138
• Other study ID #: IM103-399
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2017
• Est. completion date: April 2, 2019

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2, 2019
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Signed informed consent form.

• Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.

• Weight between 60.0 to 100.0 kg, inclusive.

• Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.

• Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.

• WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.

• Women must not be breastfeeding.

• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.

Exclusion Criteria:

• Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.

• History of shingles (herpes zoster).

• Personal or strong family history of cancer.

• Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.

• Any known or suspected autoimmune disorder.

Other protocol defined inclusion/exclusion criteria could apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• belatacept
Specified dose on specified days

Locations

Country	Name	City	State
United States	PPD Austin Clinic	Austin	Texas
United States	Covance, Inc.	Dallas	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 (AUC(INF)).	Measured by plasma concentration.	Up to day 57
Primary	Maximum observed serum concentration (Cmax).	Measured by plasma concentration.	Up to day 57
Secondary	Incidence of non-serious Adverse Events (AEs).	Safety and tolerability as measured by incidence of non-serious AEs.	Up to 71 days.
Secondary	Incidence of Serious Adverse Events (SAEs).	Safety and tolerability as measured by incidence of SAEs.	Up to 71 days.
Secondary	Incidence of Adverse Events (AEs) leading to discontinuation.	Safety and tolerability as measured by incidence of AEs leading to discontinuation.	Up to 71 days.
Secondary	Number of participants with vital sign abnormalities.		Up to 71 days.
Secondary	Number of participants with physical examination abnormalities.		Up to 71 days.
Secondary	Number of participants with clinical laboratory abnormalities.		Up to 71 days.
Secondary	Number of participants with electrocardiogram (ECG) abnormalities.		Up to 71 days.

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form