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A Study of LY3526318 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: NCT03977974
Recruitment Status : Terminated (COVID-19 pandemic.)
First Posted : June 6, 2019
Last Update Posted : April 22, 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 LY3526318 when given by mouth to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 28 days and Part B will last up to 51 days, including screening and follow-up.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3526318 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Safety, Tolerability, Pharmacokinetic, and Pilot Food Effect Study of Single- and Multiple-Ascending Doses of LY3526318 in Healthy Participants
Actual Study Start Date : June 21, 2019
Actual Primary Completion Date : March 5, 2020
Actual Study Completion Date : March 5, 2020

Arm Intervention/treatment
Experimental: LY3526318 - Part A
LY3526318 administered orally once.
Drug: LY3526318
Administered orally

Placebo Comparator: Placebo - Part A
Placebo administered orally once.
Drug: Placebo
Administered orally

Experimental: LY3526318 - Part B
LY3526318 administered once orally on consecutive days.
Drug: LY3526318
Administered orally

Placebo Comparator: Placebo - Part B
Placebo administered once orally on consecutive days.
Drug: Placebo
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 (Part A: Day 38; Part B: Day 51) ]
    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): Area Under the Concentration Versus Time Curve (AUC) of LY3526318 [ Time Frame: Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15 ]
    PK: AUC of LY3526318

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 [ Time Frame: Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15 ]
    PK: Cmax of LY3526318

  3. PK: Time to Cmax (Tmax) of LY3526318 [ Time Frame: Part A: Predose on Day 1 through Day 3; Part B: Predose on Day 1 through Day 15 ]
    PK: Tmax of LY3526318



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

Inclusion Criteria:

Part A Cohorts:

- Healthy male participants (including self-reported surgically sterile males) must agree to the following:

  • When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration
  • Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug

All Part A and Part B Cohorts:

  • Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [e.g. tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months). Healthy female participants of child-bearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from admission to 30 days after the final visit. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:

    • Hormonal contraceptive (oral, transdermal patches, vaginal or injectable)
    • Intrauterine device with or without hormones
    • Condom ('barrier' method)
    • Diaphragm or cervical cap
    • Sexual abstinence
  • Have a body mass index 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

  • Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
  • In the opinion of the investigator are considered to be a danger to themselves
  • Have an abnormality in the 12-lead electrocardiogram (ECG)
  • Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions
  • Have donated blood of more than 500 milliliter (mL) within the previous month
  • Are unwilling to stop alcohol and caffeinated beverage consumption and smoking/use of tobacco while resident in the CRU
  • Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits
  • Have an abnormal blood pressure
  • Participants with a history of drug abuse
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
  • Are unwilling to comply with the required dietary restrictions

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): NCT03977974


Locations
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Netherlands
PRA Health Sciences
Groningen, Netherlands, 9728
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: NCT03977974    
Other Study ID Numbers: 17426
J2D-MC-CVAA ( Other Identifier: Eli Lilly and Company )
2019-001902-80 ( EudraCT Number )
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: April 22, 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: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No