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Completed

NCT Number: NCT02145234

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 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.

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Key information

Conditions

Healthy Adults

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wcct Global, Llc

Cypress, California, 90630, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

BMS-986089

Drug

Placebo matching with BMS-986089

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 22, 2014
Registry last updated
Sep 7, 2017

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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