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Trial record 1 of 1 for:    NCT02593331
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Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance

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ClinicalTrials.gov Identifier: NCT02593331
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE November 1, 2015
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE October 29, 2015
Actual Primary Completion Date March 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
Percentage of Participants With Adverse Events [ Time Frame: From baseline up to 20 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • Percentage of Participants With Adverse Events [ Time Frame: From baseline up to 20 weeks ]
  • Percentage of Participants With Clinically Significant Changes in Safety Measurements Following BFKB8488A Administration, Including Vital Signs, Physical Findings, and Clinical Laboratory Results [ Time Frame: Up to 20 weeks following first dose administration ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
Serum BFKB8488A Concentration [ Time Frame: SC Cohort: predose (Hour 0), 4, 24, 72 hours post Day 1 dose, Days 6, 8, 11, 15, 22, 29, 36, 43, 57, 85, 113; IV Cohort: end of infusion on Day 1, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post Day 1 dose, Days 6, 8, 15, 22, 29, 36, 43 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • Serum BFKB8488A Concentration [ Time Frame: On multiple days during the follow-up period that is up to 20 weeks. ]
  • Percentage of participants with confirmed anti-BFKB8488A antibodies [ Time Frame: From baseline to end of study up to approximately 20 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance
Official Title  ICMJE A Phase Ia, Randomized, Blinded, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous BFKB8488A in Otherwise Healthy Overweight and Obese Volunteers With Likely Insulin Resistance
Brief Summary This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI] greater than [>] 27 to less than or equal to [</=] 40 kilograms per square meter [kg/m^2]) with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose cohorts. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will open to evaluate the PK of BFKB8488A after intravenous (IV) administration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Insulin Resistance
Intervention  ICMJE
  • Drug: BFKB8488A
    Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1.
  • Other: Placebo
    Participants will receive a single dose of placebo on Day 1.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive placebo matching to BFKB8488A.
    Intervention: Other: Placebo
  • Experimental: BFKB8488A SC
    Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort.
    Intervention: Drug: BFKB8488A
  • Experimental: BFKB8488A IV
    Participants will receive single IV dose of BFKB8488A.
    Intervention: Drug: BFKB8488A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
79
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2015)
56
Actual Study Completion Date  ICMJE March 28, 2017
Actual Primary Completion Date March 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with BMI >/=30 kg/m^2 and </=40 kg/m^2 or BMI >27 kg/m^2 and <30 kg/m^2 and Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) >3.60 or waist circumference >100 centimeters (cm) (males) or 88 cm (females) or fasting plasma insulin >/=15 milli international unit per liter (mIU/L) or fasting plasma glucose >/=100 milligrams per deciliter (mg/dL) and <126 mg/dL or hemoglobin A1c (HbA1c) >5.6 percent (%) and <6.5%
  • Negative pregnancy test

Exclusion Criteria:

  • A diagnosis of Type 2 diabetes mellitus at any time
  • Pregnant, lactating or intending to become pregnant during the study or within 3 months after the study dose is administered
  • Uncontrolled intercurrent illness or any psychiatric illness
  • Participants actively involved in a weight loss or dietary program within the last 6 months
  • History of surgical procedures for weight loss
  • History of eating disorder
  • Uncontrolled hypertension (systolic >/=140 millimeter of mercury [mmHg] or diastolic blood pressure >/=90 mmHg) either on or off therapy at screening or Day -2
  • Fasting triglycerides >500 mg/dL (5.64 millimoles per liter [mmol/L]) or low density lipoprotein (LDL) >160 mg/dL (4.14 mmol/L) at screening
  • Any serious medical condition or abnormality in clinical laboratory tests
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02593331
Other Study ID Numbers  ICMJE GC29819
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP