A Study of [14C]-LY3023703 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01965782
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

This type of study is called a radiolabeled study. For this study, LY3023703 (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 help understand how the drug appears in the blood, urine, and stool after it is administered to healthy men. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [^14C]-LY3023703	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Disposition of [14C]-LY3023703 Following Oral Administration in Healthy Subjects
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [^14C]-LY3023703 Single oral dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.	Drug: [^14C]-LY3023703; Administered orally

Outcome Measures

Primary Outcome Measures

1. Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to 168 hours post dose]

2. Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to 168 hours post dose]

Secondary Outcome Measures

1. Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax) [Predose up to 168 hours post dose]

2. Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax) [Predose up to 168 hours post dose]

3. Pharmacokinetics of LY3023703 and Radioactivity Area Under The Concentration-Time Curve From Time Zero to the Last Timepoint With a Measurable Concentration [AUC (0 to Tlast)] [Predose up to 168 hours post dose]

4. Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces [Predose up to 168 hours post dose]

5. Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma [One hour post-dose up to 72 hours post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants will either be sterile or, if sexually active, agree to use approved methods of contraception from the day before dosing until 3 months after the follow-up assessment

• Participants will refrain from sperm donation from the day before dosing until 3 months after the follow-up assessment

• Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m^2)

• Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

• Have given written informed consent approved by Lilly and the IRB governing the site

Exclusion Criteria:

• Are currently enrolled in, have participated, within the last 30 days, in a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

• Are participants who have previously completed or withdrawn from this study or any other study investigating LY3023703, and have previously received the investigational product

• Have known allergies to LY3023703, related compounds or any components of the formulation, or history of significant atopy

• Have recent or ongoing gastrointestinal (GI) symptoms or illnesses, have a history of GI bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) or cyclooxygenase (COX)2 inhibitor therapy or have active or history of recurrent peptic ulcer/hemorrhage (2 or more distinct episodes of proven ulceration or bleeding)

• Have a history of intolerance to NSAIDs or aspirin

• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

• Show evidence of alanine aminotransferase or aspartate aminotransferase levels above the normal ranges, confirmed on repeat, or a history of elevated and abnormal liver tests

• Have intended use of over-the-counter medications or prescription medication within 14 days prior to dosing. Also within 30 days prior to dosing, any drugs and dietary items that are known inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2J2 or other drugs that may affect the disposition of LY3023703 or increase risk for complications from the study

• Have consumed herbal supplements within 14 days prior to admission or grapefruit juice, grapefruits, grapefruit-containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study

• Have donated blood of more than 500 milliliter (mL) within the last month

• Have participated in a [14C]-study within the last 6 months prior to admission for this study

• Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

• A positive alcohol breathalyzer test

• A positive cotinine test

• Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until discharge from the Clinical Research Unit (CRU)

• Have a defecation pattern less than once per 2 days or acute constipation within 3 weeks of the day before dosing

• In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

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	53704

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: NCT01965782
• Other Study ID Numbers: 15097; I6H-MC-MCBD
• First Posted: Oct 18, 2013
• Last Update Posted: Aug 28, 2018
• Last Verified: Jul 1, 2018

Study Results

Participant Flow

Pre-assignment Detail	18 subjects were screened and enrolled but no drug was given or other data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Overall Participants	0
Age () []
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time Frame	Predose up to 168 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

2. Primary Outcome

Title	Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time Frame	Predose up to 168 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

3. Secondary Outcome

Title	Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax)
Time Frame	Predose up to 168 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

4. Secondary Outcome

Title	Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax)
Time Frame	Predose up to 168 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

5. Secondary Outcome

Title	Pharmacokinetics of LY3023703 and Radioactivity Area Under The Concentration-Time Curve From Time Zero to the Last Timepoint With a Measurable Concentration [AUC (0 to Tlast)]
Time Frame	Predose up to 168 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

6. Secondary Outcome

Title	Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces
Time Frame	Predose up to 168 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

7. Secondary Outcome

Title	Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma
Time Frame	One hour post-dose up to 72 hours post dose

Outcome Measure Data

Analysis Population Description

No drug was given or data collected due to the study being terminated.

Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	No drug was given or data collected due to the study being terminated.
Arm/Group Title	[^14C]-LY3023703
Arm/Group Description	Single dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution.
All Cause Mortality
	[^14C]-LY3023703
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	[^14C]-LY3023703
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	[^14C]-LY3023703
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

18 subjects were screened and enrolled but no drug was given or other data collected due to the study being terminated

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.