Clinical trial NCT03616795: Study of LY3154207 in Healthy Participants
Official title: Disposition of [14C]-LY3154207 Following Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through 552 hours after administration of study drug
measure: Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
timeFrame: Baseline through 552 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207
timeFrame: Predose through 144 hours after administration of study drug
measure: Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞])
timeFrame: Predose through 144 hours after administration of study drug
measure: Total Number of Metabolites
timeFrame: Baseline through 552 hours after administration of study drug
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.