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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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16 December 2017 |
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Main ID: |
NCT02963779 |
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Date of registration:
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10/11/2016 |
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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 LY2775240 in Healthy Participants
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Scientific title:
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A 2-Part, Safety, Tolerability, and Pharmacokinetic Study of LY2775240 in Healthy Subjects |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02963779 |
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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: Double (Participant, Investigator).
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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:
- Overtly healthy adult male or a female who cannot get pregnant
- Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32
kilograms per meter square (kg/m²), inclusive
- Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test
results that are acceptable for the study
Exclusion Criteria:
- Are currently participating in or completed a clinical trial within the last 30 days
from a clinical trial or any other type of medical research judged to be incompatible
with this study
- Have known allergies to compounds or drugs similar to LY2775240 or apremilast
- Have previously participated or withdrawn from this study
- Have or used to have health problems or medical test results or ECG readings that, in
the opinion of the doctor, could make it unsafe to participate, or could interfere
with understanding the results of 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: Apremilast
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Drug: LY2775240
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Drug: Placebo
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Primary Outcome(s)
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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 to final follow-up at approximately Week 14]
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Secondary Outcome(s)
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Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240
[Time Frame: Baseline through Day 5]
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Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240
[Time Frame: Baseline through Day 5]
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Pharmacokinetics: Maximum Concentration of LY2775240 in Blood
[Time Frame: Baseline through Day 5]
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Secondary ID(s)
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16450
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I8W-MC-PDBA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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