Healthy
Conditions
Brief summary
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
DRUGLY3502970
Administered orally
DRUG[14C]-LY3502970
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Absolute Bioavailability of LY3502970 | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma | 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: AUC \[0-∞\] of Total Radioactivity in Plasma. |
| PK: AUC [0-∞] of [14C]-LY3502970 in Plasma | 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. |
| PK: AUC [0-∞] of LY3502970 in Plasma | 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. |
| PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma | 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: Cmax of Total Radioactivity in Plasma. |
| PK: Cmax of [14C]-LY3502970 in Plasma | 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. |
| PK: Cmax of LY3502970 in Plasma | 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. |
Countries
United States
Contacts
STUDY_DIRECTORCall 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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
None listed