NCT02906618

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

October 4, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2016

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

September 15, 2016

Results QC Date

June 20, 2025

Last Update Submit

June 20, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): 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 13C 15N 2H-LY3039478

    Pharmacokinetics (PK) is the 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 13C 15N 2H-LY3039478.

    Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

  • PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478

    PK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.

    Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Secondary Outcomes (3)

  • PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV

    Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

  • PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478

    Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

  • PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478

    Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Study Arms (2)

LY3039478 - Oral

EXPERIMENTAL

LY3039478 given once, orally

Drug: LY3039478

13C 15N 2H-LY3039478 - IV

EXPERIMENTAL

13C 15N 2H-LY3039478 given once, IV

Drug: 13C 15N 2H-LY3039478 IV

Interventions

LY3039478DRUG

Administered orally

LY3039478 - Oral
13C 15N 2H-LY3039478 IVDRUG

Administered IV

13C 15N 2H-LY3039478 - IV

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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, United Kingdom

Location

MeSH Terms

Interventions

crenigacestat

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
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
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

October 4, 2016

Primary Completion

November 11, 2016

Study Completion

November 11, 2016

Last Updated

July 9, 2025

Results First Posted

July 9, 2025

Record last verified: 2025-06

Locations

GB(1)