A Study of How the Body Breaks Down and Eliminates LY2623091

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02242981
Collaborator
(none)
6
1
1
2
3

Study Details

Study Description

Brief Summary

This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Disposition of [14C]-LY2623091 Following Oral Administration in Healthy Subjects
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY2623091

Single oral dose of LY2623091

Drug: LY2623091
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)]

    Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.

Secondary Outcome Measures

  1. Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091 [Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)]

  2. Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091 [Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)]

  3. Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091 [Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)]

  4. Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces [Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).

  • With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
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. Madison Wisconsin United States

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02242981
Other Study ID Numbers:
  • 15517
  • I7T-MC-RMAA
First Posted:
Sep 17, 2014
Last Update Posted:
Jun 26, 2020
Last Verified:
Jun 1, 2020

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 milligrams (mg) LY2623091 containing carbon-14 [¹⁴C]-LY2623091 (approximately 100 microcuries [µCi]) administered orally.
Period Title: Overall Study
STARTED 6
Received Study Drug 6
COMPLETED 5
NOT COMPLETED 1

Baseline Characteristics

Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
Overall Participants 6
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
40
(14.0)
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
6
100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
Not Hispanic or Latino
6
100%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
1
16.7%
Black or African American
0
0%
White
5
83.3%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
6
100%

Outcome Measures

1. Primary Outcome
Title Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Description Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.
Time Frame Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)

Outcome Measure Data

Analysis Population Description
All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
Measure Participants 6
Feces
60.5
(4.27)
Urine
1.39
(0.454)
2. Secondary Outcome
Title Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091
Description
Time Frame Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

Outcome Measure Data

Analysis Population Description
All participants who received study drug and had evaluable AUC(0-tlast) values.
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
Measure Participants 6
Geometric Mean (Geometric Coefficient of Variation) [nanograms*hour/milliliter (ng*h/mL)]
11800
(38)
3. Secondary Outcome
Title Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091
Description
Time Frame Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

Outcome Measure Data

Analysis Population Description
All participants who received study drug and had evaluable AUC(0-inf) values.
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
Measure Participants 6
Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL]
11800
(38)
4. Secondary Outcome
Title Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091
Description
Time Frame Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)

Outcome Measure Data

Analysis Population Description
All participants who received study drug and had evaluable Cmax values.
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
Measure Participants 6
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
482
(15)
5. Secondary Outcome
Title Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces
Description
Time Frame Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose

Outcome Measure Data

Analysis Population Description
All participants who received study drug and had evaluable plasma, urine, and fecal samples.
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
Measure Participants 6
Plasma
7
Urine
NA
Feces
17

Adverse Events

Time Frame
Adverse Event Reporting Description Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
Arm/Group Title LY2623091
Arm/Group Description Single dose of 25 mg LY2623091 containing [¹⁴C]-LY2623091 (approximately 100 µCi) administered orally.
All Cause Mortality
LY2623091
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
LY2623091
Affected / at Risk (%) # Events
Total 0/6 (0%)
Other (Not Including Serious) Adverse Events
LY2623091
Affected / at Risk (%) # Events
Total 4/6 (66.7%)
Gastrointestinal disorders
Constipation 1/6 (16.7%) 1
Diarrhoea 1/6 (16.7%) 1
Proctalgia 1/6 (16.7%) 1
General disorders
Vessel puncture site bruise 1/6 (16.7%) 1
Injury, poisoning and procedural complications
Scratch 1/6 (16.7%) 1
Musculoskeletal and connective tissue disorders
Neck pain 1/6 (16.7%) 1
Nervous system disorders
Headache 1/6 (16.7%) 2
Skin and subcutaneous tissue disorders
Erythema 1/6 (16.7%) 2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Chief Medical Officer
Organization Eli Lilly and Company
Phone 800-545-5979
Email
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02242981
Other Study ID Numbers:
  • 15517
  • I7T-MC-RMAA
First Posted:
Sep 17, 2014
Last Update Posted:
Jun 26, 2020
Last Verified:
Jun 1, 2020