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

Healthy Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145234
• Other study ID #: CN001-001
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2014
• Last updated: September 5, 2017
• Start date: June 30, 2014
• Est. completion date: February 29, 2016

Study information

• Verified date: September 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• BMS-986089

• Placebo matching with BMS-986089

Locations

Country	Name	City	State
United States	Wcct Global, Llc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Single Ascending Dose (SAD) Phase 119 days
Primary	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		Multiple Ascending Dose (MAD) phase 148 days
Secondary	Maximum observed serum concentration (Cmax) for SAD and MAD		SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Secondary	Time of maximum observed serum concentration (Tmax) for SAD and MAD		SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Secondary	Serum concentration 168 h post dose (C(168H)) for SAD and MAD		SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD		SAD phase: Day1 to Day 91
Secondary	Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD		SAD phase: Day1 to Day 91
Secondary	Apparent total body clearance (CLT/F) for SAD		SAD phase: Day1 to Day 91
Secondary	Volume of distribution of terminal phase (if IV and if multi-exponential decline) (Vz/F) for SAD		SAD phase: Day1 to Day 91
Secondary	Half life (T-Half) for SAD and MAD		SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Secondary	Serum concentration 336 h post dose (C(336H)) for SAD and MAD		SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Secondary	Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) for MAD		MAD phase: Day 1 to Day 120
Secondary	Area under the concentration-time curve in one dosing interval (AUC(TAU)) for MAD		MAD phase: Day 1 to Day 120
Secondary	Degree of Fluctuation or Fluctuation Index (DF) for MAD		MAD phase: Day 1 to Day 120
Secondary	Average concentration over a dosing interval (Css-Avg) for MAD		MAD phase: Day 1 to Day 120
Secondary	AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI AUC) for MAD		MAD phase: Day 1 to Day 120
Secondary	Cmax Accumulation Index; ratio of Cmax at steady-state to Cmax after the first dose (AI Cmax) for MAD		MAD phase: Day 1 to Day 120
Secondary	C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD		MAD phase: Day 1 to Day 120
Secondary	C(336H) Accumulation Index; ratio of C(336H) at steady-state to C(336H) after the first dose (AI 336H) for MAD		MAD phase: Day 1 to Day 120
Secondary	Immunogenicity of single and multiple doses of BMS-986089 will be measured by testing for the presence of ADAs for SAD and MAD		30 days
Secondary	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		30 days

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