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A Study of LY3154885 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: NCT04014361
Recruitment Status : Suspended (Enrollment suspended pending business decision.)
First Posted : July 10, 2019
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date April 27, 2020
Actual Study Start Date  ICMJE August 9, 2019
Estimated Primary Completion Date January 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
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 Study Completion (up to 70 days) ]
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: July 9, 2019)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 [ Time Frame: Predose up to 96 hours postdose ]
    PK: Cmax of LY3154885
  • PK: Time to Cmax (Tmax) of LY3154885 [ Time Frame: Predose up to 96 hours postdose ]
    PK: Tmax of LY3154885
  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3154885 [ Time Frame: Predose up to 96 hours postdose ]
    PK: AUC of LY3154885
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 LY3154885 in Healthy Participants
Official Title  ICMJE Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects
Brief Summary The main purpose of this study is to learn more about the safety and side effects of LY3154885 when given by mouth to healthy participants. The study will have up to four parts. Each participant will enroll in only one part. The study will last up to 70 days for each participant, including screening and follow-up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Part D will be open-label.
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LY3154885 - Capsule
    Administered orally.
  • Drug: Placebo - Capsule
    Administered orally.
  • Drug: Itraconazole
    Administered orally.
  • Drug: LY3154885 - Tablet
    Administered orally.
Study Arms  ICMJE
  • Experimental: LY3154885 - Part A
    LY3154885 administered orally in two of three study periods.
    Intervention: Drug: LY3154885 - Capsule
  • Placebo Comparator: Placebo - Part A
    Placebo administered orally in one of three study periods.
    Intervention: Drug: Placebo - Capsule
  • Experimental: LY3154885 - Part B
    LY3154885 administered orally alone.
    Intervention: Drug: LY3154885 - Capsule
  • Placebo Comparator: Placebo - Part B
    Placebo administered orally alone.
    Intervention: Drug: Placebo - Capsule
  • Experimental: LY3154885 + Itraconazole - Part B
    LY3154885 administered alone, orally, once. Itraconazole administered alone, orally, on consecutive days. LY3154885 co-administered with itraconazole, orally, once.
    Interventions:
    • Drug: LY3154885 - Capsule
    • Drug: Itraconazole
  • Placebo Comparator: Placebo + Itraconazole - Part B
    Placebo administered alone, orally, once. Itraconazole administered alone, orally, on consecutive days. Placebo co-administered with itraconazole, orally, once.
    Interventions:
    • Drug: Placebo - Capsule
    • Drug: Itraconazole
  • Experimental: LY3154885 - Part C
    LY3154885 administered orally on consecutive days.
    Intervention: Drug: LY3154885 - Capsule
  • Placebo Comparator: Placebo - Part C
    Placebo administered orally on consecutive days.
    Intervention: Drug: Placebo - Capsule
  • Experimental: LY3154885 - Part D
    LY3154885 administered orally once in each of three study periods.
    Interventions:
    • Drug: LY3154885 - Capsule
    • Drug: LY3154885 - Tablet
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 Suspended
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 27, 2021
Estimated Primary Completion Date January 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Male participants:

    • Men, regardless of their fertility status, with partners who are nonpregnant women of childbearing potential, must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms with spermicide as well as 1 additional highly effective (<1% failure rate) method of contraception or effective method of contraception (such as diaphragms with spermicide) for 3 months following dosing
    • Men with pregnant partners should use condoms with spermicide during intercourse for the duration of the study or for 3 months following dosing, whichever is longer
    • Men who are in exclusively same-sex relationships (as their preferred and usual lifestyle) or with female partners of nonchildbearing potential are not required to use contraception
    • Men should refrain from sperm donation for the duration of the study or for 3 months following the last dose of study drug, whichever is longer
  • Female participants of nonchildbearing potential, including those who are:

    • Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, confirmed tubal ligation, or tubal occlusion) or congenital anomaly such as Müllerian agenesis; or
    • Postmenopausal, defined as 1 of the following:

      • A woman at least 50 years of age with an intact uterus, not on hormone replacement therapy, who has had either:

        • Cessation of menses for at least 1 year; or
        • At least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone level ≥40 milli-international units per milliliter (mIU/mL) at screening
      • A woman at least 55 years of age, not on hormone replacement therapy, who has had at least 6 months of spontaneous amenorrhea; or
      • A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy
  • Have a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

  • Have a marked baseline prolongation of/corrected QT (QTc) interval (for example, repeated demonstration of a QTcB interval >450 milliseconds [msec] for males or >470 msec for females);

    • A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome);
    • The use of concomitant medications that prolong the QT/QTc interval
  • Have an abnormal blood pressure (BP) (taken after the participant has been in a supine position for at least 5 minutes) for the population, as determined by a systolic BP >140 millimeters of mercury (mmHg) or a diastolic BP >90 mmHg at screening or a preexisting history of hypertension. Up to 2 additional measurements may be taken after an appropriate resting interval at screening to confirm eligibility
  • Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism, hyperaldosteronism), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product (IMP); or of interfering with the interpretation of data
  • Have a history of or current significant psychiatric disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 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 NCT04014361
Other Study ID Numbers  ICMJE 17051
J1Z-MC-HUAA ( 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
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
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 April 2020

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