NCT01640249

Brief Summary

The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal. This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

July 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

July 24, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2012

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

August 8, 2019

Completed
Last Updated

August 8, 2019

Status Verified

June 1, 2019

Enrollment Period

4 months

First QC Date

July 11, 2012

Results QC Date

April 3, 2019

Last Update Submit

June 28, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs

    AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.

    Baseline, up to 21 days

Secondary Outcomes (2)

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072

    Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose

  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072

    Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning.

Drug: Placebo

LY3006072

EXPERIMENTAL

Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg.

Drug: LY3006072

Interventions

PlaceboDRUG

Capsules administered orally

Placebo
LY3006072DRUG

Capsules administered orally

LY3006072

Eligibility Criteria

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

You may qualify if:

  • Overtly healthy males or females, as determined by medical history and physical examination
  • Male participants with a partner of childbearing potential must agree to use barrier protection during sexual intercourse while in the study and for 3 months after the last dose of study drug
  • Women must not be pregnant or nursing and must be of non-childbearing potential, due to either surgical sterilization or menopause
  • Body mass index between 19.0 and 30.0 kilograms per square meter (kg/m\^2), inclusive

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Evansville, Indiana, 47710, United States

Location

Limitations and Caveats

Part B was not initiated as study was terminated early due to technical factors.

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 13, 2012

Study Start

July 24, 2012

Primary Completion

November 26, 2012

Study Completion

November 26, 2012

Last Updated

August 8, 2019

Results First Posted

August 8, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)