Healthy
Conditions
Brief summary
The purposes of this study are to determine: * If there are any differences in the way LY3202626 is handled by the body when taken in two different forms * Whether a high fat meal affects the way the body handles LY3202626 * How well tolerated LY3202626 is There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626. The study will last about 50 days, not including screening.
Interventions
DRUGLY3202626 (R-Fasting)
Administered orally
DRUGLY3202626 (T1-Fasting)
Administered orally
DRUGLY3202626 (T1-Fed)
Administered orally
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination * Female participants must be of non-childbearing potential confirmed by medical history or menopause * Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening
Exclusion criteria
* Are investigative site personnel directly affiliated with this study and their immediate families * Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * 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has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed * Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product * Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, 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 a history of head trauma with loss of consciousness within the last 5 years * Have known or ongoing psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose | Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626 |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose | PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626 |
| PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose | PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626 |
Countries
Singapore
Participant flow
Pre-assignment details
Participants were randomized to 1 of 6 sequences in 3 periods.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Single oral 12 mg dose of LY3202626 capsule (R) under fasting conditions, LY3202626 tablet (T1) under fasting conditions and LY3202626 tablet (T1) following a high-fat meal. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 1 Participants |
| Region of Enrollment Singapore | 26 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 8 / 25 | 7 / 26 | 9 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 25 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626
Pharmacokinetics (PK) is the maximum observed drug concentration (Cmax) of LY3202626
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Population: All randomized participants who received at least one dose and who had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3202626 (R-Fasting) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | 27.9 nanogram/milliliter (ng/mL) | Standard Deviation 64 |
| 12 mg LY3202626 (T1-Fasting) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | 36.1 nanogram/milliliter (ng/mL) | Standard Deviation 45 |
| 12 mg LY3202626 (T1-Fed) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3202626 | 39.4 nanogram/milliliter (ng/mL) | Standard Deviation 42 |
Primary
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626
PK is the area under the concentration versus time curve from time zero to infinity (AUC\[0-∞\]) of LY3202626
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3202626 (R-Fasting) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | 540 hour*nanogram/milliliter (h*ng/mL) | Standard Deviation 62 |
| 12 mg LY3202626 (T1-Fasting) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | 707 hour*nanogram/milliliter (h*ng/mL) | Standard Deviation 45 |
| 12 mg LY3202626 (T1-Fed) | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3202626 | 702 hour*nanogram/milliliter (h*ng/mL) | Standard Deviation 46 |
Primary
PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626
PK is the AUC from time zero to time t, where t is the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3202626
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and who had evaluable PK data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 12 mg LY3202626 (R-Fasting) | PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | 531 h*ng/mL | Standard Deviation 62 |
| 12 mg LY3202626 (T1-Fasting) | PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | 667 h*ng/mL | Standard Deviation 47 |
| 12 mg LY3202626 (T1-Fed) | PK: AUC From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3202626 | 691 h*ng/mL | Standard Deviation 45 |