NCT03616795

Brief Summary

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Aug 2018

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

August 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

August 1, 2018

Last Update Submit

November 21, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

    Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

    Baseline through 552 hours after administration of study drug

  • Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

    Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

    Baseline through 552 hours after administration of study drug

Secondary Outcomes (3)

  • Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207

    Predose through 144 hours after administration of study drug

  • Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞])

    Predose through 144 hours after administration of study drug

  • Total Number of Metabolites

    Baseline through 552 hours after administration of study drug

Study Arms (1)

LY3154207 and [14C]-LY3154207

EXPERIMENTAL

A single dose of LY3154207 and \[14C\]-LY3154207administered orally.

Drug: LY3154207Drug: [14C]-LY3154207

Interventions

LY3154207DRUG

Administered orally

LY3154207 and [14C]-LY3154207
[14C]-LY3154207DRUG

Administered orally

LY3154207 and [14C]-LY3154207

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have a body mass index (BMI) of 19 to 32.0 kilogram per meter square (kg/m²)
  • Are 18 to 50 years old, inclusive, at the time of screening

You may not qualify if:

  • Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
  • Are unwilling to refrain from consuming caffeine- or xanthine-containing food and drink from 48 hours prior to admission and while resident in the CRU
  • Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
  • Have participated in a \[14C\]-study within the last 4 to 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of 1 other previous \[14C\]-study within 6 to 12 months of this study (if the previous studies' radiation exposure is not known) or a maximum of 2 other previous \[14C\]-studies within 4 to 12 months of this study
  • Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

  • Wilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7.

    PMID: 33029934DERIVED

MeSH Terms

Interventions

LY3154207

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 6, 2018

Study Start

August 9, 2018

Primary Completion

November 5, 2018

Study Completion

November 5, 2018

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

US(1)