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Trial record 4 of 4 for:    LY3361237

A Study of LY3361237 in Healthy Participants

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: NCT03695198
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 4, 2018
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE October 26, 2018
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Week 12 ]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 [ Time Frame: Predose through Week 12 ]
    PK: Cmax of LY3361237
  • PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237 [ Time Frame: Predose through Week 12 ]
    PK: AUC of LY3361237
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3361237 in Healthy Participants
Official Title  ICMJE A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects
Brief Summary

The purposes of this study are to determine:

  • The safety of LY3361237 and any side effects that might be associated with it.
  • How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants.

Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.

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: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LY3361237 - SC
    LY3361237 administered SC
  • Drug: LY3361237 - IV
    LY3361237 administered IV
  • Drug: Placebo - SC
    Placebo administered SC
  • Drug: Placebo - IV
    Placebo administered IV
Study Arms  ICMJE
  • Experimental: LY3361237 - Subcutaneous (SC)
    LY3361237 administered SC
    Intervention: Drug: LY3361237 - SC
  • Placebo Comparator: Placebo - SC
    Placebo administered SC
    Intervention: Drug: Placebo - SC
  • Experimental: LY3361237 - Intravenous (IV)
    LY3361237 administered IV
    Intervention: Drug: LY3361237 - IV
  • Placebo Comparator: Placebo - IV
    Placebo administered IV
    Intervention: Drug: Placebo - IV
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: September 2, 2019)
64
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2018)
85
Actual Study Completion Date  ICMJE August 29, 2019
Actual Primary Completion Date August 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males or females, as determined by medical history and physical examination.
  • To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
  • Between 18 (20 for Japanese participants) and 65 years of age.
  • Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms.

Exclusion Criteria:

  • Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing
  • Are immunocompromised
  • Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening
  • Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
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 NCT03695198
Other Study ID Numbers  ICMJE 16969
I9S-MC-BTAA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date September 1, 2019

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