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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3154885 - Capsule Drug: Placebo - Capsule Drug: Itraconazole Drug: LY3154885 - Tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Part D will be open-label.
Primary Purpose: Basic Science
Official Title: Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : January 27, 2021
Estimated Study Completion Date : January 27, 2021

Arm Intervention/treatment
Experimental: LY3154885 - Part A
LY3154885 administered orally in two of three study periods.
Drug: LY3154885 - Capsule
Administered orally.

Placebo Comparator: Placebo - Part A
Placebo administered orally in one of three study periods.
Drug: Placebo - Capsule
Administered orally.

Experimental: LY3154885 - Part B
LY3154885 administered orally alone.
Drug: LY3154885 - Capsule
Administered orally.

Placebo Comparator: Placebo - Part B
Placebo administered orally alone.
Drug: Placebo - Capsule
Administered orally.

Experimental: LY3154885 + Itraconazole - Part B
LY3154885 administered alone, orally, once. Itraconazole administered alone, orally, on consecutive days. LY3154885 co-administered with itraconazole, orally, once.
Drug: LY3154885 - Capsule
Administered orally.

Drug: Itraconazole
Administered orally.

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.
Drug: Placebo - Capsule
Administered orally.

Drug: Itraconazole
Administered orally.

Experimental: LY3154885 - Part C
LY3154885 administered orally on consecutive days.
Drug: LY3154885 - Capsule
Administered orally.

Placebo Comparator: Placebo - Part C
Placebo administered orally on consecutive days.
Drug: Placebo - Capsule
Administered orally.

Experimental: LY3154885 - Part D
LY3154885 administered orally once in each of three study periods.
Drug: LY3154885 - Capsule
Administered orally.

Drug: LY3154885 - Tablet
Administered orally.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 [ Time Frame: Predose up to 96 hours postdose ]
    PK: Cmax of LY3154885

  2. PK: Time to Cmax (Tmax) of LY3154885 [ Time Frame: Predose up to 96 hours postdose ]
    PK: Tmax of LY3154885

  3. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3154885 [ Time Frame: Predose up to 96 hours postdose ]
    PK: AUC of LY3154885



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014361


Locations
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United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04014361    
Other Study ID Numbers: 17051
J1Z-MC-HUAA ( Other Identifier: Eli Lilly and Company )
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Itraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors