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Compare Bioavailability of BMS-986089 After Subcutaneous Injection

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ClinicalTrials.gov Identifier: NCT03100630
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
Randomized study in healthy men and women. Assess the similarity of BMS-986089 when injected into the arm, thigh, or the stomach. Collect data on safety of BMS-986089.

Condition or disease Intervention/treatment Phase
Healthy Drug: BMS-986089 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BMS-986089 in Healthy Participants
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : September 30, 2017

Arm Intervention/treatment
Active Comparator: Treatment A: BMS-986089
BMS-986089 subcutaneous injections on specified days; abdomen
Drug: BMS-986089
Specified dose on specified days

Active Comparator: Treatment B: BMS-986089
BMS-986089 subcutaneous injections on specified days; arm
Drug: BMS-986089
Specified dose on specified days

Active Comparator: Treatment C: BMS-986089
BMS-986089 subcutaneous injections on specified days; thigh
Drug: BMS-986089
Specified dose on specified days




Primary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) [ Time Frame: Up to 92 days ]
  2. AUC from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to 92 days ]
  3. AUC from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 92 days ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events ( AEs) [ Time Frame: Up to 92 days ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 92 days ]
  3. Change from baseline in electrocardiogram findings [ Time Frame: Up to 92 days ]
  4. Change from baseline in physical examination findings [ Time Frame: Up to 92 days ]
  5. Change from baseline in clinical laboratory test findings [ Time Frame: Up to 92 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
  • Body Mass Index 18 kg/m2 to 32 kg/m2
  • females must be of non-childbearing potential

Exclusion Criteria:

  • tattoos or other skin findings on any of the potential injection sites
  • history of chronic muscle pain within 30 days prior to study treatment
  • prior history of IgG1 therapy

Other protocol defined inclusion and exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100630


Contacts
Contact: Reference Study ID Number: WP40225 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
United States, California
WCCT Global, LLC Recruiting
Cypress, California, United States, 90630
Contact: , Site 0001         
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Additional Information:
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03100630     History of Changes
Other Study ID Numbers: CN001-023
WP40225 ( Other Identifier: Hoffman LaRoche Protocol ID )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No