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

NCT03714022 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IM101-682
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Serum Concentration (Cmax)

  Maximum Observed Serum Concentration

  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

  From drug administration to 70 days following drug administration

Secondary Outcomes (21)

• Time of Maximum Observed Serum Concentration (Tmax)

  From drug administration to 70 days following drug administration

• Area Under the Curve AUC(0-T)

  From drug administration to 70 days following drug administration

• Area Under the Curve AUC(0-28)

  From drug administration to 70 days following drug administration

• Total Body Clearance (CLT)

  From drug administration to 70 days following drug administration

• Volume of Distribution at Steady-State (Vss)

  From drug administration to 70 days following drug administration

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will receive abatacept at a single dose of 750 mg as IV infusion on Day 1 converted from drug substance by a new process.

Drug: Abatacept

Treatment B

ACTIVE COMPARATOR

Participants will receive abatacept at a single dose 750 mg as IV infusion on Day 1 converted from drug substance by converted from drug substance by the current process.

Drug: Abatacept

Interventions

Abatacept DRUG

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

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

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

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

Please email

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: November 9, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: January 7, 2021
• Results First Posted: January 7, 2021

Record last verified: 2021-01

Locations

US (2)