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Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02145234
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Adults Drug: BMS-986089 Drug: Placebo matching with BMS-986089 Phase 1

Detailed Description:

Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects

Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96

Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
Actual Study Start Date : June 30, 2014
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : February 29, 2016

Arm Intervention/treatment
Experimental: SAD Panel 1:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: SAD Panel 2:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: SAD Panel 3:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: SAD Panel 4:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: SAD Panel 5:BMS-986089/Placebo

BMS-986089 in a single subcutaneous administration

OR

Placebo matching with BMS-986089 in a single subcutaneous administration

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 1:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 multiple subcutaneous administrations weekly

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 2:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 3:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 4:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 5:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administration every 2 weeks

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 6:BMS-986089/Placebo

BMS-986089 in multiple subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly

Drug: BMS-986089
Drug: Placebo matching with BMS-986089
Experimental: MAD Panel 7:BMS-986089/Placebo

BMS-986089 a single subcutaneous administrations weekly

OR

Placebo matching with BMS-986089 a single subcutaneous administration every 2 weeks

Drug: BMS-986089
Drug: Placebo matching with BMS-986089



Primary Outcome Measures :
  1. Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations [ Time Frame: Single Ascending Dose (SAD) Phase 119 days ]
  2. Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations [ Time Frame: Multiple Ascending Dose (MAD) phase 148 days ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) for SAD and MAD [ Time Frame: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 ]
  2. Time of maximum observed serum concentration (Tmax) for SAD and MAD [ Time Frame: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 ]
  3. Serum concentration 168 h post dose (C(168H)) for SAD and MAD [ Time Frame: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 ]
  4. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD [ Time Frame: SAD phase: Day1 to Day 91 ]
  5. Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD [ Time Frame: SAD phase: Day1 to Day 91 ]
  6. Apparent total body clearance (CLT/F) for SAD [ Time Frame: SAD phase: Day1 to Day 91 ]
  7. Volume of distribution of terminal phase (if IV and if multi-exponential decline) (Vz/F) for SAD [ Time Frame: SAD phase: Day1 to Day 91 ]
  8. Half life (T-Half) for SAD and MAD [ Time Frame: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 ]
  9. Serum concentration 336 h post dose (C(336H)) for SAD and MAD [ Time Frame: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120 ]
  10. Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  11. Area under the concentration-time curve in one dosing interval (AUC(TAU)) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  12. Degree of Fluctuation or Fluctuation Index (DF) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  13. Average concentration over a dosing interval (Css-Avg) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  14. AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI AUC) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  15. Cmax Accumulation Index; ratio of Cmax at steady-state to Cmax after the first dose (AI Cmax) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  16. C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  17. C(336H) Accumulation Index; ratio of C(336H) at steady-state to C(336H) after the first dose (AI 336H) for MAD [ Time Frame: MAD phase: Day 1 to Day 120 ]
  18. Immunogenicity of single and multiple doses of BMS-986089 will be measured by testing for the presence of ADAs for SAD and MAD [ Time Frame: 30 days ]
  19. The pharmacodynamic effect of single and multiple doses of BMS-986089 on free myostatin, total myostatin (pre-dose only), and myostatin-drug complex will be assessed by measuring these biomarkers for SAD and MAD [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
  • Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years
  • Women must not be breastfeeding
  • Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year

Exclusion Criteria:

  • Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration
  • Any condition that will clearly require medical or surgical treatment during the period of study participation
  • Any bone trauma or bone surgery within 3 months of study drug administration
  • Known or suspected autoimmune disorder
  • Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study

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): NCT02145234


Locations
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United States, California
Wcct Global, Llc
Cypress, California, United States, 90630
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

Additional Information:
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02145234    
Other Study ID Numbers: CN001-001
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017