A Study of Donanemab (LY3002813) in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567159
• Other study ID #: 18616
• Secondary ID: I5T-MC-AACP
• Status: Completed
• Phase: Phase 1
• Start date: October 4, 2022
• Est. completion date: July 14, 2023

Study information

• Verified date: August 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation
• Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.
• Females of childbearing potential will be excluded from the study.

Exclusion Criteria:

• Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
• Have a history within the past 5 years of a primary or recurrent malignant disease
• Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing
• Are pregnant or intend to become pregnant or to breastfeed during the study
• Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions
• Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Donanemab
Administered IV.

Locations

Country	Name	City	State
United States	ICON Early Phase Services Lenexa Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Four weeks (AUC[0-4 weeks]) of Donanemab	PK: AUC[0-4 weeks] of Donanemab	Predose up to 28 days postdose
Primary	PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab	PK: Cmax, ss of Donanemab	Predose up to 28 days postdose
Primary	PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCt,ss) of Donanemab	PK: AUCt,ss of Donanemab	Predose up to 28 days postdose