Healthy
Conditions
Brief summary
The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.
Interventions
DRUGMidazolam
Administered orally.
DRUGLY3502970
Administered orally.
DRUGCyclosporine
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are overtly healthy as determined by medical evaluation * Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²) * Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants * Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
Exclusion criteria
* Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs * Participants who regularly use known drugs of abuse * Women who are lactating and who are of child-bearing potential * Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose | PK: AUC of LY3502970 |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose | PK: Cmax of LY3502970 |
Countries
Singapore
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
Participant flow
Recruitment details
This is a 2-period single arm study with a washout period of at least 14 days between Period 1 and Period 2.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Region of Enrollment Singapore | 31 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 0 / 24 | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 4 / 31 | 28 / 31 | 18 / 24 | 22 / 24 | 20 / 25 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 24 | 0 / 24 | 0 / 25 |
Outcome results
None listed