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Completed

NCT Number: NCT01746745

A Study of LY2940680 in Healthy Participants

This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and laboratory assessments
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive

Exclusion criteria

  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have consumed herbal supplements, 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 milliliters (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)
  • Have a pattern less than once per 2 days to expel feces from the bowel through the rectum or acute constipation within 3 weeks of the day prior to dose

Treatment and study plan

[^14C]-LY2940680

Drug

Administered as solution by mouth

Primary outcomes

  1. Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to 14 days postdose. Samples collected at 24-h intervals.

    The percentage of the total radioactive dose administered that was excreted in feces = [(amount of radioactivity recovered in feces)/(radioactive dose administered)]*100.

  2. Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Predose up to 14 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.

    The percentage of the total radioactive dose administered that was excreted in urine=[(amount of radioactivity recovered in urine)/(radioactive dose administered)]*100.

Secondary outcomes

  1. Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax)

    Time frame: Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter

    The Cmax of LY2940680 and its equipotent active metabolite in the free base form, LSN3185556, is reported.

  2. PK of Radioactivity: Cmax

    Time frame: Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.

  3. PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax)

    Time frame: Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.

    The Tmax of LY2940680, LSN3185556, and total radioactivity in plasma are reported, as well as the Tmax for total radioactivity in whole blood.

  4. Plasma PK of LY2940680 and LSN3185556: Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration [AUC(0 to Tlast)]

    Time frame: Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.

  5. PK of Radioactivity: AUC(0 to Tlast)

    Time frame: Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.

    AUC(0 to Tlast) of total radioactivity in plasma and whole blood are reported in nanograms*hour equivalents per gram (ng*h Eq/g).

  6. Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma

    Time frame: Day 1 up to 3 days postdose. Samples collected at 2, 3, 4, 6, and 8 h postdose on Day 1 and every 24 h thereafter.

    Relative abundance was expressed and calculated as the percentage of plasma sample radioactivity=[(radioactivity in peak)/(radioactivity in sample)]*100. Metabolites with a relative abundance ≤6% are not reported.

  7. Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine

    Time frame: Predose up to 4 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.

    Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported.

  8. Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces

    Time frame: Predose up to 8 days postdose. Samples collected at 24-h intervals.

    Relative abundance was expressed and calculated as the percentage of the administered dose excreted in feces=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Disposition of [14C]-LY2940680 Following Oral Administration in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2012
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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