Clinical trial NCT03692949: A Study of LY3451838 in Healthy Participants
Official title: A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 53
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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 35 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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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

Primary outcomes:
measure: Number of Participants with any Treatment Emergent Adverse Event
timeFrame: Baseline through twenty weeks
measure: Number of Participants with One or More Serious Adverse Events
timeFrame: Baseline through twenty weeks
Secondary outcomes:
measure: Area Under the Concentration Versus Time Curve (AUC) of LY3451838
timeFrame: Pre-dose through twenty weeks
measure: Maximum Concentration (Cmax) of LY3451838
timeFrame: Pre-dose through twenty weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: