Skip to main content
OpenTrials
Completed

NCT Number: NCT05567159

A Study of Donanemab (LY3002813) in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services Lenexa Center

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donanemab

Drug

Administered IV.

Other names: LY3002813

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.

    Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71

    As per the prespecified analysis, AUC[0-4 weeks] will be calculated as the sum of AUC0-2weeks for:

    • treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2
    • treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4
    • treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.

  2. PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab

    Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71

    PK: Cmax, ss of Donanemab

  3. PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab

    Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71

    PK: AUCτ,ss of Donanemab

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2022
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.