Clinical trial NCT00569803: Subcutaneous Pharmacokinetics of Belatacept
Official title: Pharmacokinetics, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Transplantation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Men and women ages 18 to 65 years old
* Subjects must weigh less than or equal to 100 kg

Exclusion Criteria:

* Inability to tolerate injections or IV infusions
* autoimmune disorders
* TB
* herpes
* HCV
* HBV
* HIV
* bacterial or viral infection
* history of cancer

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Time of Maximum Observed Serum Concentration (Tmax) of Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-T)) for Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Serum Half-life (T-HALF) of Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Apparent Total Body Clearance (CLT/F) of SC Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Total Body Clearance (CLT) of IV Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Volume of Distribution at Steady State (VSS) for IV Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
Secondary outcomes:
measure: Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption
timeFrame: Immediately before dose, 0.5, 2, 6, 12, 24, 36, 48, 60, 72, 84 hours post-dose, Days 5, 6, 7, 8, 14, 21, 28, 35, 42, 56, 86 and 116
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: 1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116
measure: Number of Participants With Injection Site Reactions
timeFrame: 0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Days 1, 2, 5, 14, 28, 42, 86, 116
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Days 1 and 116
measure: Number of Participants With Marked Hematology Laboratory Abnormalities
timeFrame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
measure: Number of Participants With Marked Serum Chemistry Abnormalities
timeFrame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
measure: Number of Participants With Marked Laboratory Abnormalities
timeFrame: Day 1 Pre-dose, Days 2, 5, 14, 28, 42, 86, 116
measure: Number of Participants With Positive Immunogenicity to Belatacept
timeFrame: Days 1, 14, 28, 42, 56, 86, 116
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: