A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/5/2016 |
| Start Date: | October 2015 |
| End Date: | May 2016 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: |
| Email: | Clinical.Trials@bms.com |
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
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept
relative to Process C belatacept in Healthy subjects
relative to Process C belatacept in Healthy subjects
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 -
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