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Completed

NCT Number: NCT03714022

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qps-Mra, Llc, South Miami, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abatacept

Drug

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

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

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

    Maximum Observed Serum Concentration

  2. Area Under the Curve AUC(INF)

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

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

Secondary outcomes

  1. Time of Maximum Observed Serum Concentration (Tmax)

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

    Time of maximum observed serum concentration

  2. Area Under the Curve AUC(0-T)

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

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

  3. Area Under the Curve AUC(0-28)

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

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

  4. Total Body Clearance (CLT)

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

    Total body clearance

  5. Volume of Distribution at Steady-State (Vss)

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

    Volume of distribution at steady-state

  6. Terminal Phase Elimination Half-life (T-HALF)

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

    Terminal phase elimination half-life in serum

  7. Number of Participants Experiencing Positive Immunogenicity Response to Abatacept

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

    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.

  8. Number of Participants Experiencing Adverse Events

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

    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

  9. Change From Baseline in Blood Pressure

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in systolic and diastolic blood pressure values

  10. Change From Baseline in Heart Rate

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in heart rate values

  11. Change From Baseline in Respiration Rate

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in respiration rate values

  12. Change From Baseline in Body Temperature

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in body temperature values

  13. Change From Baseline in Electrocardiogram (ECG) Parameters

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia

  14. Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities

    Time frame: From the pre-treatment period to 70 days after start of study medication (approximately 100 days)

    Number of participants experiencing clinically significant physical examination abnormal findings

  15. Change From Baseline in Laboratory Test Results - Hematology 1

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - Hematology parameters 1

  16. Change From Baseline in Laboratory Test Results - Hematology 2

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - Hematology parameters 2

  17. Change From Baseline in Laboratory Test Results - Hematology 3

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - Hematocrit

  18. Change From Baseline in Laboratory Test Results - Chemistry 1

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - Chemistry parameters 1

  19. Change From Baseline in Laboratory Test Results - Chemistry 2

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - Chemistry parameters 2

  20. Change From Baseline in Laboratory Test Results - Chemistry 3

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - Chemistry parameters 3

  21. Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4

    Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication

    Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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