Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants
Verified date | January 2021 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | April 2, 2019 |
Est. primary completion date | April 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | PPD Development, LP | Austin | Texas |
United States | Qps-Mra, Llc | South Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Observed Serum Concentration (Cmax) | Maximum Observed Serum Concentration | From drug administration to 70 days following drug administration | |
Primary | Area Under the Curve AUC(INF) | Area under the serum concentration-time curve from time zero extrapolated to infinity | From drug administration to 70 days following drug administration | |
Secondary | Time of Maximum Observed Serum Concentration (Tmax) | Time of maximum observed serum concentration | From drug administration to 70 days following drug administration | |
Secondary | 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 | From drug administration to 70 days following drug administration | |
Secondary | Area Under the Curve AUC(0-28) | Area under the serum concentration-time curve from time zero to 28 days after dosing | From drug administration to 70 days following drug administration | |
Secondary | Total Body Clearance (CLT) | Total body clearance | From drug administration to 70 days following drug administration | |
Secondary | Volume of Distribution at Steady-State (Vss) | Volume of distribution at steady-state | From drug administration to 70 days following drug administration | |
Secondary | Terminal Phase Elimination Half-life (T-HALF) | Terminal phase elimination half-life in serum | From drug administration to 70 days following drug administration | |
Secondary | Number of Participants Experiencing Positive Immunogenicity Response to Abatacept | Positive immunogenicity response to Abatacept was defined if one of the following criteria was met:
missing baseline immunogenicity measurement and a positive, post-baseline, laboratory-reported immunogenicity response; a negative laboratory-reported baseline immunogenicity response and a positive, post-baseline, laboratory-reported response; 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. |
From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71 | |
Secondary | 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 | From drug administration to 56 days following drug administration | |
Secondary | Change From Baseline in Blood Pressure | Mean Change from Baseline in systolic and diastolic blood pressure values | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Heart Rate | Mean Change from Baseline in heart rate values | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Respiration Rate | Mean Change from Baseline in respiration rate values | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Body Temperature | Mean Change from Baseline in body temperature values | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Electrocardiogram (ECG) Parameters | Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities | Number of participants experiencing clinically significant physical examination abnormal findings | From the pre-treatment period to 70 days after start of study medication (approximately 100 days) | |
Secondary | Change From Baseline in Laboratory Test Results - Hematology 1 | Mean Change from Baseline in laboratory test results - Hematology parameters 1 | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Laboratory Test Results - Hematology 2 | Mean Change from Baseline in laboratory test results - Hematology parameters 2 | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Laboratory Test Results - Hematology 3 | Mean Change from Baseline in laboratory test results - Hematocrit | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Laboratory Test Results - Chemistry 1 | Mean Change from Baseline in laboratory test results - Chemistry parameters 1 | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Laboratory Test Results - Chemistry 2 | Mean Change from Baseline in laboratory test results - Chemistry parameters 2 | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Laboratory Test Results - Chemistry 3 | Mean Change from Baseline in laboratory test results - Chemistry parameters 3 | From baseline (last result before start of study medication) to 70 days after start of study medication | |
Secondary | Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 | Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4 | From baseline (last result before start of study medication) to 70 days after start of study medication |
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