Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Phase I Study of LY3502970 in Healthy Participants

NCTNCT06085482Other id18596Other idJ2A-MC-GZGO

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 10 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 19 Oct 2023
Primary completion: 5 Jan 2024
Completion: 5 Jan 2024
First posted: 17 Oct 2023
Last update posted: 27 May 2026
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 1
A Phase I Study of LY3502970 in Healthy Participants
NCT06085482
19 Oct 2023 to 5 Jan 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.

Interventions

LY3502970Drug
[14C]-LY3502970Drug

Arms1

Experimental
LY3502970 + [14C]-LY3502970
Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 (\[14C\]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity.

Primary outcomes1

Outcomes the sponsor listed as primary.

Pharmacokinetics (PK): Absolute Bioavailability of LY3502970
Time frame · Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.
Registry description
Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed \[14C\]-LY3502970 compared to oral dosed LY3502970, using formula: \[AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)\] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.

Secondary outcomes(6)

PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma
Time frame · 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose
Registry description
PK: AUC \[0-∞\] of Total Radioactivity in Plasma.
PK: AUC [0-∞] of [14C]-LY3502970 in Plasma
Time frame · 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose
Registry description
PK: AUC \[0-∞\] of \[14C\]-LY3502970 in Plasma.
PK: AUC [0-∞] of LY3502970 in Plasma
Time frame · Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose
Registry description
PK: AUC \[0-∞\] of LY3502970 in Plasma.
PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma
Time frame · 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose
Registry description
PK: Cmax of Total Radioactivity in Plasma.
PK: Cmax of [14C]-LY3502970 in Plasma
Time frame · 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose
Registry description
PK: Cmax of \[14C\]-LY3502970 in Plasma.
PK: Cmax of LY3502970 in Plasma
Time frame · Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose
Registry description
PK: Cmax of LY3502970 in Plasma.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.

Pharmacokinetics (PK): Absolute Bioavailability of LY3502970

Group	Value (Percentage)	Spread
LY3502970 + [14C]-LY3502970	77	27

Secondary and other outcome results(6)

Secondary outcomeGeometric mean· 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma

Group	Value (nanogram equivalent*hour per milliliter)	Spread
LY3502970 + [14C]-LY3502970	3.71	29

Secondary outcomeGeometric mean· 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

PK: AUC [0-∞] of [14C]-LY3502970 in Plasma

Group	Value (nanogram equivalent*hour per milliliter)	Spread
LY3502970 + [14C]-LY3502970	2.91	19

Secondary outcomeGeometric mean· Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

PK: AUC [0-∞] of LY3502970 in Plasma

Group	Value (nanogram*hour per milliliter)	Spread
LY3502970 + [14C]-LY3502970	108	35

Secondary outcomeGeometric mean· 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma

Group	Value (nanogram equivalent per milliliter)	Spread
LY3502970 + [14C]-LY3502970	2.10	59

Secondary outcomeGeometric mean· 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

PK: Cmax of [14C]-LY3502970 in Plasma

Group	Value (nanogram equivalent per milliliter)	Spread
LY3502970 + [14C]-LY3502970	2.08	53

Secondary outcomeGeometric mean· Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

PK: Cmax of LY3502970 in Plasma

Group	Value (nanogram per milliliter)	Spread
LY3502970 + [14C]-LY3502970	5.43	42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LY3502970 + [14C]-LY3502970Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.	0 / 10	0 / 10	2 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation * Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive * Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study Exclusion Criteria: * Participants who have known allergies to LY3502970, related compounds, or any components of the formulation * Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study * Participants who regularly use known drugs of abuse or show positive findings on drug screen

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