A Study of LY3314814 in Healthy Participants

NCT03222427 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 15993I8D-MC-AZEP2017-001181-18
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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-∞) 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 Outcomes (1)

• 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

Study Arms (2)

LY3314814

EXPERIMENTAL

Single 50 milligram (mg) dose of LY3314814 administered orally

Drug: LY3314814

[13C415N3] LY3314814

EXPERIMENTAL

Single 100 micrograms (μg) intravenous (IV) dose of \[13C415N3\] LY3314814 administered as an IV infusion.

Drug: [13C415N3] LY3314814

Interventions

LY3314814 DRUG

Administered orally

LY3314814

[13C415N3] LY3314814 DRUG

Administered as an IV infusion

[13C415N3] LY3314814

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are overtly healthy males or females
• Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (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

Location

Related Links

• CSP
• SAP
• CSP
• SAP

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

Clinicaltrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: January 15, 2018
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2018
• Last Updated: October 31, 2019
• Results First Posted: March 22, 2019

Record last verified: 2019-10

Locations

GB (1)