A Study of LY3451838 in Healthy Participants
Sponsor:
Eli Lilly and Company
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | December 2018 | ||
| Estimated Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Number of Participants with any Treatment Emergent Adverse Event[ Time Frame: Baseline through twenty weeks ] Serious and other non-serious adverse events will be reported in the Adverse Events Module Number of Participants with One or More Serious Adverse Events[ Time Frame: Baseline through twenty weeks ] Serious and other non-serious adverse events will be reported in the Adverse Events Module |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | A Study of LY3451838 in Healthy Participants |
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| Official Title ICMJE | A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects |
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| Brief Summary | The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin). |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 1 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Basic Science |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
80 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | November 2019 | ||
| Estimated Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Male participants must adhere to contraception restrictions - Female participants must be of non-childbearing potential due to: - Menopause: spontaneous amenorrhea for at least 12 months not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (e.g., oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) - Surgical sterilization - Have a body mass index of 18 to 32 kilograms per square meter (kg/m²) - Have clinical laboratory test results within normal reference range or with acceptable deviations - Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area - Have venous access sufficient to allow for blood sampling Exclusion Criteria: - Are currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study - Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, renal, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality - Have history of or presence of uncontrolled asthma, significant atopy, or significant rheumatological or autoimmune diseases - Have had lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years (with some exceptions) - Have used, or intend to use some prescription or over the counter medications, including herbal medications within 14 days prior to dosing - Have an abnormality in the 12-lead electrocardiogram (ECG) or Fridericia's corrected QT (QTcF) - Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen - Have donated blood of more than 450 milliliters (mL) within the last 3 months - Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit (CRU) - Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females (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) - Current smoker of more than 10 cigarettes or equivalent per day and unable to stop smoking while in the CRU - Have an abnormal blood pressure - Have clinically significant proteinuria or hematuria - Positive findings for known drugs of abuse - Have received treatment with biologic agents within 3 months or 5 half-lives (whichever is longer) - Have clinically significant allergies, or intolerance to corticosteroids, or severe post treatment hypersensitivity reactions | ||
| Sex/Gender |
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| Ages | 21 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Eli Lilly and Company | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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