Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks. This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.
Interventions
DRUGLY2886721 in a Capsule
Administered orally.
DRUGLY2886721 in an orally disintegrating tablet (ODT)
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
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive, at screening * At least 4 participants who are greater than 55 years of age * Male participants: Agree to use a reliable method of birth control and not donate sperm during the study and for 3 months following the last dose of the investigational product * Female participants: Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy, or both) confirmed by medical history, or postmenopausal females, as determined by medical history and physical examination (spontaneous amenorrhea for 6 to 12 months and a follicle stimulating hormone \[FSH\] level greater than 40 milli-international units per milliliter \[mIU/mL\]) * Have venous access sufficient to allow for blood sampling as per the protocol
Exclusion criteria
* Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical trial involving an investigational product; or are concurrently enrolled in 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 * Have known allergies to LY2886721, related compounds, or any components of the formulation * Have an abnormality in the 12-lead electrocardiogram (ECG) * Have a significantly abnormal blood pressure as determined by the investigator * Have a history 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 study medication; or of interfering with the interpretation of data * Regularly use known drugs of abuse and/or show positive findings on urinary drug screening * Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies * Show evidence of hepatitis B or C and/or positive hepatitis B or C antibody * Have a history of, or current, significant ophthalmologic disease * Show evidence of significant active neuropsychiatric disease or history of suicide attempt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | Baseline through 96 hours post-dose |
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | Baseline through 96 hours post-dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | Baseline through 96 hours post-dose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | Baseline through 96 hours post-dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall All participants who entered the study and received at least 1 dose of study drug. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| LY2886721 Capsule (Water, Fasting) | Adverse Event | 1 |
| LY2886721 ODT (Water, Fasting) | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 17.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 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 | 5 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 | 21 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 23 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 26 | 8 / 26 | 6 / 25 | 7 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 25 | 0 / 24 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721
Time frame: Baseline through 96 hours post-dose
Population: Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-∞) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2886721 Capsule (Water, Fasting) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | 2320 nanograms * hour / milliliter | Geometric Coefficient of Variation 24 |
| LY2886721 ODT (no Water, Fasting) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | 2390 nanograms * hour / milliliter | Geometric Coefficient of Variation 19 |
| LY2886721 ODT (Water, Fed) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | 2490 nanograms * hour / milliliter | Geometric Coefficient of Variation 19 |
| LY2886721 ODT (Water, Fasting) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721 | 2290 nanograms * hour / milliliter | Geometric Coefficient of Variation 18 |
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721
Time frame: Baseline through 96 hours post-dose
Population: Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-tlast) data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2886721 Capsule (Water, Fasting) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | 2300 nanograms * hour / milliliter | Geometric Coefficient of Variation 24 |
| LY2886721 ODT (no Water, Fasting) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | 2380 nanograms * hour / milliliter | Geometric Coefficient of Variation 19 |
| LY2886721 ODT (Water, Fed) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | 2480 nanograms * hour / milliliter | Geometric Coefficient of Variation 19 |
| LY2886721 ODT (Water, Fasting) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721 | 2270 nanograms * hour / milliliter | Geometric Coefficient of Variation 18 |
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721
Time frame: Baseline through 96 hours post-dose
Population: Participants who received at least one dose of study drug with evaluable LY2886721 Cmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY2886721 Capsule (Water, Fasting) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | 183 nanograms / milliliter (ng/mL) | Geometric Coefficient of Variation 46 |
| LY2886721 ODT (no Water, Fasting) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | 195 nanograms / milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
| LY2886721 ODT (Water, Fed) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | 181 nanograms / milliliter (ng/mL) | Geometric Coefficient of Variation 18 |
| LY2886721 ODT (Water, Fasting) | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 | 173 nanograms / milliliter (ng/mL) | Geometric Coefficient of Variation 37 |
Primary
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721
Time frame: Baseline through 96 hours post-dose
Population: Participants who received at least one dose of study drug with evaluable LY2886721 tmax data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LY2886721 Capsule (Water, Fasting) | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | 3.00 hours |
| LY2886721 ODT (no Water, Fasting) | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | 2.00 hours |
| LY2886721 ODT (Water, Fed) | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | 4.00 hours |
| LY2886721 ODT (Water, Fasting) | Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721 | 2.00 hours |