A Study of LY3314814 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3314814; Drug: [13C415N3] LY3314814

• Registration Number: NCT03222427
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-19
• Study Start: 2018-01-15
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Results First Submitted: 2018-12-13
• Results First Submitted QC: 2018-12-13
• Results First Posted: 2019-03-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-18
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3314814	LY3314814	Single 50 milligram (mg) dose of LY3314814 administered orally
[13C415N3] LY3314814	[13C415N3] LY3314814	Single 100 micrograms (μg) intravenous (IV) dose of \[13C415N3\] LY3314814 administered as an IV infusion.

Primary Outcome Measures

Name	Time	Method
Absolute Bioavailability of 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	Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) 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	Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC\[0 ∞\]) of LY3314814 and \[13C415N3\] LY3314814

Trial Locations

Locations (1)

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, United Kingdom