Study of LY3039478 in Healthy Participants

Healthy Clinical Trial

Official title:

An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906618
• Other study ID #: 16344
• Secondary ID: I6F-MC-JJCG2016-
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2016
• Last updated: January 24, 2017
• Start date: October 4, 2016
• Est. completion date: November 11, 2016

Study information

• Verified date: January 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:

• How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV

• How long it takes the body to remove the study drug

• The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 11, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Exclusion Criteria:

• Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product

• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3039478
Administered orally
• 3C 15N 2H-LY3039478 IV
Administered IV

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

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: Area Under the Concentration versus Time Curve (AUC) from Time Zero to the Last Time Point with a Measurable Concentration (AUC[0 tlast]) of LY3039478 and 3C 15N 2H-LY3039478		Predose through 48 hours after administration of study drug
Primary	Pharmacokinetics: AUC from Zero to Infinity (AUC[0 - inf]) of LY3039478 and 3C 15N 2H-LY3039478		Predose through 48 hours after administration of study drug
Secondary	Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY3039478		Predose through 48 hours after administration of study drug
Secondary	Pharmacokinetics: Time of Cmax (tmax) of LY3039478		Predose through 48 hours after administration of study drug
Secondary	Pharmacokinetics: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478		Predose through 48 hours after administration of study drug