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

Completed · Phase 1

Conditions studied: Renal Transplantation

In brief

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

Key facts

Study ID

NCT02564497

Run by

Bristol-Myers Squibb

People needed

491

Starts

2015-10-02

Expected to finish

2017-01-27

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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 -

Where it is running

• PPD Development — Austin, Texas, United States

Full record on ClinicalTrials.gov

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