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NCT03222427 Clinical Trial

A Study of LY3314814 in Healthy Participants

Healthy Clinical Trial

Official title:
An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03222427
Other study ID # 15993
Secondary ID I8D-MC-AZEP2017-
Status Completed
Phase Phase 1
First received
Last updated
Start date January 15, 2018
Est. completion date February 16, 2018

Study information
Verified date October 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date February 16, 2018
Est. primary completion date February 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Are overtly healthy males or females

- Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product

Exclusion Criteria:

- Have a history of significant ophthalmic disease

- Have vitiligo or any other clinically significant disorder of skin pigmentation

- Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY3314814
Administered orally
• [13C415N3] LY3314814
Administered as an IV infusion

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 (2)
Lead Sponsor Collaborator
AstraZeneca Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute Bioavailability of LY3314814 Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-8) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814. Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Secondary Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 8]) of LY3314814 and [13C415N3] LY3314814 Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 8]) of LY3314814 and [13C415N3] LY3314814 Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
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