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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
NCT03099148 |
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Date of registration:
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30/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of LY3337641 in Healthy Participants
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Scientific title:
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Relative Bioavailability and the Effect of Food on the Bioavailability of LY3337641 in Healthy Subjects |
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Date of first enrolment:
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April 4, 2017 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03099148 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Singapore
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Are overtly healthy males or females, as determined by medical history and physical
examination
- Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²)
inclusive
- Have clinical laboratory test results within normal reference range for the population
or investigative site
- Are able and willing to give signed informed consent
Exclusion Criteria:
- Have participated, within the last 30 days, in a clinical trial involving an
investigational product. If the previous investigational product has a long half-life,
3 months or 5 half-lives (whichever is longer) should have passed
- Have significant history of or current cardiovascular, dermatological (such as eczema,
psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy
is not acceptable), endocrine, hematological, or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs; of
constituting a risk when taking the investigational product; or of interfering with
the interpretation of data
- Have used or intend to use over-the-counter or prescription medication, including
herbal medications, within 14 days prior to planned dosing
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the
study
Age minimum:
21 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: LY3337641 (T1)
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Drug: Reference Formulation (R)
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Drug: LY3337641 (T2)
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Primary Outcome(s)
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
[Time Frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose]
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Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of LY3337641
[Time Frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose]
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Secondary ID(s)
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16298
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I8K-MC-JPDF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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