Phase 1
Completed N=146
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
Renal Transplantation
Source: ClinicalTrials.gov NCT02564497 ↗
Enrolled (actual)
146
Serious AEs
0.7%
Results posted
Apr 2019
Primary outcomePrimary: Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept. — 17084539; 21579398 ng.h/mL
Summary
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept. |
17084539; 21579398 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Belatacept |
269305; 255169 | — |
| SECONDARY Time of Maximum Observed Serum Concentration (Tmax) |
1.00; 1.00 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T) |
17020284; 21422168 | — |
| SECONDARY Total Body Clearance (CLT) |
0.0433; 0.0343 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) |
7.89; 7.35 | — |
| SECONDARY Half Life (T-HALF) |
160; 183 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 -
Data sourced from ClinicalTrials.gov (NCT02564497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.