A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes

Bristol-Myers Squibb140 enrolled

Overview

The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept drug product converted from drug substance by a new drug substance process (Treatment A) relative to the current drug substance process (Treatment B) following a single dose (750 mg) intravenous (IV) infusion in healthy participants.

Participants will be admitted to the clinical facility the day prior to dosing (Day -1) and will be confined until at least 24 hours post-dose. On Day 1, eligible participants will be randomized in a 1:1 ratio to either Treatment A or Treatment B. The randomization will be stratified by weight categories: \>= 60 to \< 70 kg, \>= 70 to \< 80 kg, \>= 80 to \< 90 kg, and \>= 90 to \<= 100 kg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Rheumatoid Arthritis

Interventions

AbataceptDRUG

Participants will receive abatacept at a single dose 750 mg as IV infusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight will be between 60 and 100 kg, inclusive. * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study treatment. * Women must not be breastfeeding. * WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus 30 days (duration of ovulatory cycle) for a total of 115 days post-treatment completion. * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus the duration of spermatogenesis (90 days) for a total of 175 days after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time. Exclusion Criteria: * Participants who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Participants who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations. * Participants with a history of herpes zoster. * Donation of blood to a blood bank or in a clinical study (except a screening visit or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks of study treatment administration for plasma only). * Blood transfusion within 4 weeks of study treatment administration. * Recent (within 6 months of study treatment administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges, or nicotine gum. * History of allergy to abatacept or related compounds.

Locations (2)

Qps-Mra, Llc

South Miami, Florida, United States

PPD Development, LP

Austin, Texas, United States

Outcomes

Primary Outcomes

Maximum Observed Serum Concentration (Cmax)

Maximum Observed Serum Concentration

Time frame: From drug administration to 70 days following drug administration

Area Under the Curve AUC(INF)

Area under the serum concentration-time curve from time zero extrapolated to infinity

Time frame: From drug administration to 70 days following drug administration

Secondary Outcomes

Time of Maximum Observed Serum Concentration (Tmax)

Time of maximum observed serum concentration

Time frame: From drug administration to 70 days following drug administration

Area Under the Curve AUC(0-T)

Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration

Time frame: From drug administration to 70 days following drug administration

Area Under the Curve AUC(0-28)

Area under the serum concentration-time curve from time zero to 28 days after dosing

Time frame: From drug administration to 70 days following drug administration

Total Body Clearance (CLT)

Total body clearance

Time frame: From drug administration to 70 days following drug administration

Volume of Distribution at Steady-State (Vss)

Volume of distribution at steady-state

Time frame: From drug administration to 70 days following drug administration

Data from ClinicalTrials.gov

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Terminal Phase Elimination Half-life (T-HALF)

Terminal phase elimination half-life in serum

Time frame: From drug administration to 70 days following drug administration

Number of Participants Experiencing Positive Immunogenicity Response to Abatacept

Positive immunogenicity response to Abatacept was defined if one of the following criteria was met: 1. missing baseline immunogenicity measurement and a positive, post-baseline, laboratory-reported immunogenicity response; 2. a negative laboratory-reported baseline immunogenicity response and a positive, post-baseline, laboratory-reported response; 3. a positive, laboratory-reported, baseline immunogenicity response and a positive, post-baseline, laboratory-reported immunogenicity response with a titer value greater than the baseline titer value.

Time frame: From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71

Number of Participants Experiencing Adverse Events

Number of participants experiencing different types of Adverse Events (AEs). Peri-infusional AEs: occurring during the 30 minute study drug infusion period Post-infusional AEs: occurring within 24 hours post drug infusion

Time frame: From drug administration to 56 days following drug administration

Change From Baseline in Blood Pressure

Mean Change from Baseline in systolic and diastolic blood pressure values