A Study of LY3451838 in Healthy Participants

Healthy Clinical Trial

Official title:

A Safety, Tolerability, and Pharmacokinetics Study of LY3451838 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692949
• Other study ID #: 17123
• Secondary ID: J1H-MC-LAJA
• Status: Completed
• Phase: Phase 1
• Start date: December 11, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: March 1, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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currently enrolled in or discontinued from a clinical trial within the last 30 days, or have previously completed or withdrawn from this study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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3451838
One dose administered (IV)
• Placebo
Administered IV
• Placebo
Administered SC
• LY3451838
One dose administered SC

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with any Treatment Emergent Adverse Event	Serious and other non-serious adverse events will be reported in the Adverse Events Module	Baseline through twenty weeks
Primary	Number of Participants with One or More Serious Adverse Events	Serious and other non-serious adverse events will be reported in the Adverse Events Module	Baseline through twenty weeks
Secondary	Area Under the Concentration Versus Time Curve (AUC) of LY3451838	Pharmacokinetics (PK): AUC of LY3451838	Pre-dose through twenty weeks
Secondary	Maximum Concentration (Cmax) of LY3451838	PK: Cmax of LY3451838	Pre-dose through twenty weeks