Healthy
Conditions
Brief summary
The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.
Interventions
DRUGLY3314814
Administered orally
DRUG[13C415N3] LY3314814
Administered as an IV infusion
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females * Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product
Exclusion criteria
* Have a history of significant ophthalmic disease * Have vitiligo or any other clinically significant disorder of skin pigmentation * Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Bioavailability of LY3314814 | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose | Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose | Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC\[0 ∞\]) of LY3314814 and \[13C415N3\] LY3314814 |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY3314814 + [13C415N3] LY3314814 Single 50 milligram (mg) dose of LY3314814 administered orally simultaneously with a single 100 microgram (μg) intravenous (IV) infusion of \[13C415N3\] LY3314814 over 2 hours on Day 1. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | LY3314814 + [13C415N3] LY3314814 |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 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 | 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 | 8 Participants |
| Region of Enrollment United Kingdom | 8 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Absolute Bioavailability of LY3314814
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.
Time frame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Population: All participants who received at least one dose of study drug and have evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY3314814 | Absolute Bioavailability of LY3314814 | 60.5 nanogram*hour per milliliter per mg | Geometric Coefficient of Variation 41 |
| [13C415N3] LY3314814 | Absolute Bioavailability of LY3314814 | 59.2 nanogram*hour per milliliter per mg | Geometric Coefficient of Variation 17 |
90% CI: [0.769, 1.18]
Secondary
Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC\[0 ∞\]) of LY3314814 and \[13C415N3\] LY3314814
Time frame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Population: All participants who received one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY3314814 | Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | 3020 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 41 |
| [13C415N3] LY3314814 | Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814 | 5.92 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 17 |