Renal TransplantationPhase 1NCT02564497
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
A Phase 1 study testing Process E Belatacept and Process C Belatacept in people with Renal Transplantation, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Process E Belatacept and Process C Belatacept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2015to 27 Jan 2017
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
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 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
- Conditions
- Renal Transplantation
- Being tested
- Process E Belatacept, Process C Belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process E BelataceptBiological
Process C BelataceptBiological
| Study group | Role | What they receive |
|---|---|---|
| Process E Belatacept | Other | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process E Receives: Biological: Process E Belatacept |
| Process C Belatacept | Other | Active Pharmaceutical Ingredient (API) of Belatacept manufactured by Process C Receives: Biological: Process C Belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Day 1 to Day 71
Secondary outcomes (5)
Time of Maximum Observed Serum Concentration (Tmax)
Tmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Tmax was measured in hours (h).
Measured: 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)
(AUC[0-T]) 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)
Measured: Day 1 to Day 71
Total Body Clearance (CLT)
CLT was the volume of belatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). CLT was measured in liters per hour.
Measured: Day 1 to Day 71
Volume of Distribution at Steady State (Vss)
Measured: Day 1 to Day 71
Half Life (T-HALF)
Measured: Day 1 to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start2 Oct 2015
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564497
- Sponsor's protocol ID
- IM103-349
- Status last verified
- Dec 2018
- First submitted
- 29 Sep 2015
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No