Healthy
Conditions
Brief summary
The purposes of this study are to determine: * If there are any differences in the amount of LY3337641 in the blood/body when it is taken in different formulations. A total of 3 different formulations of LY3337641 are being tested. * How a high-fat meal affects the amount of LY3337641 in the blood/body. * How safe and well tolerated LY3337641 is. The study has four periods. Individuals will participate in all four periods. Each period will include 4 overnight stays (5 days) in the Clinical Research Unit (CRU). This study is expected to last up to 8 weeks. This includes the initial screening period, the study or dosing period, and the follow up period.
Interventions
DRUGReference Formulation (R)
Administered PO
DRUGLY3337641 (T1)
20 mg PO
DRUGLY3337641 (T2)
20 mg PO
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive * Have clinical laboratory test results within normal reference range for the population or investigative site * Are able and willing to give signed informed consent
Exclusion criteria
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed * Have significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data * Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing * In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose | Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641 |
Countries
Singapore
Participant flow
Recruitment details
4 period, 4 sequence, randomized crossover study with at least 5 days between doses.
Participants by arm
| Arm | Count |
|---|---|
| Overall All randomized participants who received at least 1 dose of study drug. | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Wash-out | Adverse Event | 0 | 1 | 0 | 0 |
| Wash-out | scheduling conflict | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 7.6 |
| Body Mass Index (BMI) | 25.53 kilograms per meter squared STANDARD_DEVIATION 2.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 29 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 | 29 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 6 / 28 | 4 / 29 | 5 / 27 | 2 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3337641
Time frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Reference Formulation (R-fasted) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | 373 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 44 |
| LY3337641 (T1-fasted) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | 371 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 47 |
| LY3337641 (T1-fed) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | 351 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 42 |
| LY3337641 (T2-fasted) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641 | 361 nanograms*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 43 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641
Time frame: Period 1,2,3,4 (Day 1): Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48 and 72 hours postdose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Reference Formulation (R-fasted) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | 66.7 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 40 |
| LY3337641 (T1-fasted) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | 64.9 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 41 |
| LY3337641 (T1-fed) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | 56.8 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 44 |
| LY3337641 (T2-fasted) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3337641 | 65.5 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 35 |