Subcutaneous Pharmacokinetics of Belatacept

NCT00569803 | Completed Phase 1 Results

• 1 other identifier: IM103-046
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transplantation

Outcome Measures

Primary Outcomes (9)

• Maximum Observed Serum Concentration (Cmax) of Belatacept

  Maximum observed serum concentration (Cmax) values were derived from serum concentration versus time data and reported in micrograms per milliliter (ug/mL).

  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

• Time of Maximum Observed Serum Concentration (Tmax) of Belatacept

  Time of maximum observed serum concentration (Tmax) values were derived from serum concentration versus time data for all participants treated with Belatacept.

  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

• 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

  Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\*h/mL).

  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

• Adjusted Geometric Means of Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) for Belatacept

  Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was derived from serum concentration versus time data. Adjusted geometric means were reported in microgram hours per milliliter (ug\*h/mL)

  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

• Serum Half-life (T-HALF) of Belatacept

  Serum half-life (T-HALF) was determined from serum concentration versus time data and was reported in hours.

  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

• Apparent Total Body Clearance (CLT/F) of SC Belatacept

  Apparent total body clearance (CLT/F) was derived from serum concentration versus time data for all participants who received subcutaneous (SC) Belatacept injections. Units reported in milliliters per hour (mL/h).

  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

• Total Body Clearance (CLT) of IV Belatacept

  Total body clearance (CLT) was derived from serum concentration versus time data for all participants that were treated with IV Belatacept. Units reported in milliliters per hour (mL/h)

  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

• Volume of Distribution at Steady State (VSS) for IV Belatacept

  Volume of distribution at steady state (VSS) was derived from serum concentration versus time data for all participants treated with IV Belatacept.

  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

• Apparent Volume of Distribution at Steady State (Vss/F) for SC Belatacept

  Apparent volume of distribution at steady state (Vss/F) was derived from concentration versus time data for all participants treated with subcutaneous (SC) Belatacept.

  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 (9)

• Effect of Number of Injection Sites on Subcutaneous Belatacept Absorption

  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

• Number of Participants With Vital Sign Abnormalities

  1 day pre-dose, Days 1, 2, 5, 14, 28, 42, 86 and 116

• Number of Participants With Injection Site Reactions

  0.5, 2, 6 and 24 hours post-dose, Days 3, 4, 5, 6, 7, 8, 14, 21 and 116

• Number of Participants With Physical Examination Abnormalities

  Days 1, 2, 5, 14, 28, 42, 86, 116

• Number of Participants With Electrocardiogram (ECG) Abnormalities

  Days 1 and 116

Study Arms (8)

Belatacept 50 mg Subcutaneous Injection

ACTIVE COMPARATOR

Belatacept 50 mg subcutaneous (SC) injection

Drug: belatacept

Belatacept 100 mg Subcutaneous Injection

ACTIVE COMPARATOR

Belatacept 100 mg SC injection

Drug: belatacept

Belatacept 125 mg Subcutaneous Injection

ACTIVE COMPARATOR

Belatacept 125 mg SC injection

Drug: belatacept

Belatacept 150 mg Subcutaneous Injections

ACTIVE COMPARATOR

2 SC injections of 75 mg Belatacept

Drug: belatacept

Belatacept 200 mg Subcutaneous Injections

ACTIVE COMPARATOR

2 SC injections of 100 mg Belatacept

Drug: belatacept

Belatacept 250 mg Subcutaneous Injections

ACTIVE COMPARATOR

2 SC injections of 125 mg Belatacept

Drug: belatacept

Belatacept 125 mg Intravenous Infusion

ACTIVE COMPARATOR

125 mg Belatacept intravenous (IV) injection

Drug: belatacept

Placebo

PLACEBO COMPARATOR

SC injection of placebo solution

Drug: Placebo

Interventions

belatacept DRUG

single dose, 116 days

Belatacept 100 mg Subcutaneous Injection; Belatacept 125 mg Intravenous Infusion; Belatacept 125 mg Subcutaneous Injection; Belatacept 150 mg Subcutaneous Injections; Belatacept 200 mg Subcutaneous Injections; Belatacept 250 mg Subcutaneous Injections; Belatacept 50 mg Subcutaneous Injection

Placebo DRUG

Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Ppd Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 7, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: September 22, 2016
• Results First Posted: August 15, 2016

Record last verified: 2016-08

Locations

US (1)