A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053622
• Other study ID #: 16542
• Secondary ID: I6T-MC-AMAL2016-
• Status: Completed
• Phase: Phase 1
• Start date: April 24, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: February 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive

• Have medical test results that are acceptable for the study

• Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

• Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study

• Have known allergies to compounds or drugs similar to Mirikizumab

• Have previously participated or withdrawn from this study

• Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Mirikizumab Test
Administered SC
• Mirikizumab Test
Administered IV
• Mirikizumab Reference
Administered SC

Locations

Country	Name	City	State
United Kingdom	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-8]) of Mirikizumab	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC[0-8]) of Mirikizumab	0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Secondary	PK: Maximum Observed Concentration (Cmax) of Mirikizumab	PK: Maximum Observed Concentration (Cmax) of Mirikizumab	0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Secondary	PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab	PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab	0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose