Health TrialsbyHealthPanel

A Study of LY4515100 in Healthy Male Participants

ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to evaluate how the body handles \[¹⁴C\]-LY4515100. The study will investigate how much \[¹⁴C\]-LY4515100 enters the bloodstream from the stomach or intestines and is available to have an effect on the body, how the body changes \[¹⁴C\]-LY4515100 so that it can be used or removed, and how the body gets rid of \[¹⁴C\]-LY4515100. For each participant, the study will last about 9 weeks and will include a Clinical Research Unit (CRU) stay lasting between 10 and 30 days.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Are overtly healthy as determined by medical evaluation.

Have a body mass index (BMI) within the range of 18.0 to 35.0 kilograms per square meter (kg/m²), inclusive.

Disqualifiers

Have significant previous or current history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinal, hematological, neurological, thromboembolism, or bleeding disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study intervention; or of interfering with the interpretation of data.

Have a significant history of or current psychiatric disorders.

Have history of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs. Uncomplicated appendectomy and hernia repair will be allowed.

Have a history of constipation or have had acute constipation within 3 weeks prior to check-in.

Trial design

Design model

Parallel

Treatments tested in this trial

  • [¹⁴C]-LY4515100 Oral Solution

    Drug

    \[¹⁴C\]-LY4515100 administered orally

  • LY4515100 Tablet

    Drug

    LY4515100 administered orally

  • [¹⁴C]-LY4515100 IV

    Drug

    \[¹⁴C\]-LY4515100 administered IV

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: [¹⁴C]-LY4515100 Part 1Experimental treatment 1 intervention
Group B: LY4515100 + [¹⁴C]-LY4515100 Part 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: Urinary Excretion of [¹⁴C]-LY4515100 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame
Predose Up to Day 14
2

Part 1: Fecal Excretion of [¹⁴C]-LY4515100 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame
Predose Up to Day 14
3

Part 2: Dose Normalized Ratio of the Area Under the Concentration-Time Curve After Oral Administration (AUCpo) to Area Under the Concentration-Time Curve After Intravenous Administration (AUCiv) of LY4515100

Time frame
Predose Up to Day 14

Secondary outcomes

1

Part 1: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity

Time frame
Predose Up to Day 14
2

Part 1: PK: Maximum Concentration (Cmax) of Total Plasma Radioactivity

Time frame
Predose Up to Day 14
3

Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air

Time frame
Predose Up to Day 14
4

Part 1: Total Number of Metabolites of LY4515100 in Urine, Feces, and Plasma

Time frame
Predose Up to Day 14

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: