Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). This is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.
Interventions
DRUGLY3316531 - IV
Administered IV.
DRUGLY3316531 - SC
Administered SC.
DRUGPlacebo - IV
Administered IV.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Participants * Are overtly healthy males or females, as determined by medical history and physical examination * Females must be of non-childbearing potential * Are between 18 and 64 years of age, inclusive, at screening * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive * Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * Psoriasis Participants: * Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline * Meet psoriasis disease activity criteria * Are at least 18 years of age * Have a minimum body weight of 50 kilograms (kg)
Exclusion criteria
* Healthy and Psoriasis Participants * Have known or ongoing neuropsychiatric disorders * Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study * Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline * Show evidence of active or latent tuberculosis (TB) * Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data * Psoriasis Participants Only: * Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy) * Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval * Have received systemic nonbiologic psoriasis therapy within 28 days of baseline * Have received topical psoriasis treatment within 14 days of baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Pre-dose up to 1 year after administration of study drug | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85 | PK: Cmax of LY3316531 following the Day 57 dose. |
| Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose | PK: Cmax of LY3316531. |
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose | PK: Cmax of LY3316531. Under time frame, hours was abbreviated as hrs. |
| Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau | Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85 | AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose. |
| Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose | Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞). |
| Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose | Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞). |
Countries
United States
Participant flow
Recruitment details
Study consists of three parts: * Part A (Single-Ascending Dose (SAD) in healthy participants) * Part B (Multiple-dose in healthy participants) and * Part C (Single dose in psoriasis participants)
Participants by arm
| Arm | Count |
|---|---|
| Placebo - Part A Participants received single IV doses of Placebo. | 11 |
| 3 mg LY3316531 IV - Part A Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV). | 3 |
| 15 mg LY3316531 IV - Part A Participants received single doses of 15 mg LY3316531 administered IV. | 3 |
| 75 mg LY3316531 IV - Part A Participants received single doses of 75 mg LY3316531 administered IV. | 6 |
| 300 mg LY3316531 IV - Part A Participants received single doses of 300 mg LY3316531 administered IV. | 6 |
| 300 mg LY3316531 SC- Part A Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC). | 6 |
| 900 mg LY3316531 IV - Part A Participants received single doses of 900 mg LY3316531 administered IV. | 6 |
| 2000 mg LY3316531 IV - Part A Participants received single doses of 2000 mg LY3316531 administered IV. | 6 |
| Placebo - Part B Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks). | 2 |
| 2000 mg LY3316531 IV - Part B Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks). | 6 |
| 300 mg LY3316531 IV - Part C Participants with psoriasis received single doses of 300 mg LY3316531 administered IV. | 8 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | 3 mg LY3316531 IV - Part A | 15 mg LY3316531 IV - Part A | 75 mg LY3316531 IV - Part A | 300 mg LY3316531 IV - Part A | 300 mg LY3316531 SC- Part A | 900 mg LY3316531 IV - Part A | Placebo - Part A | 2000 mg LY3316531 IV - Part A | Placebo - Part B | 2000 mg LY3316531 IV - Part B | 300 mg LY3316531 IV - Part C |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 11 Participants | 6 Participants | 2 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 4 Participants | 4 Participants | 9 Participants | 4 Participants | 1 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 5 Participants | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 1 Participants | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 2 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 63 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 11 Participants | 6 Participants | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Female | 17 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 46 Participants | 2 Participants | 2 Participants | 4 Participants | 5 Participants | 6 Participants | 4 Participants | 7 Participants | 5 Participants | 1 Participants | 5 Participants | 5 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 | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 5 / 11 | 1 / 3 | 1 / 3 | 1 / 6 | 1 / 6 | 5 / 6 | 2 / 6 | 1 / 6 | 1 / 2 | 4 / 6 | 7 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 1 / 6 | 0 / 8 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
Time frame: Pre-dose up to 1 year after administration of study drug
Population: All randomized participants who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 3 mg LY3316531 IV - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 15 mg LY3316531 IV - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 75 mg LY3316531 IV - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 300 mg LY3316531 IV - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 300 mg LY3316531 SC- Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 900 mg LY3316531 IV - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 2000 mg LY3316531 IV - Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Placebo - Part B | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 2000 mg LY3316531 IV - Part B | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 1 Participants |
| 300 mg LY3316531 IV - Part C | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
Secondary
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531. Under time frame, hours was abbreviated as hrs.
Time frame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
Population: All randomized participants in Part A who received study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 1.27 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 18 |
| 3 mg LY3316531 IV - Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 9.94 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 26 |
| 15 mg LY3316531 IV - Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 32.7 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 22 |
| 75 mg LY3316531 IV - Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 115 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 11 |
| 300 mg LY3316531 IV - Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 27.2 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 30 |
| 300 mg LY3316531 SC- Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 453 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 14 |
| 900 mg LY3316531 IV - Part A | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 808 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 15 |
Secondary
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Time frame: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose
Population: All randomized participants in Part A who received study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 401 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 7 |
| 3 mg LY3316531 IV - Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 3050 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 23 |
| 15 mg LY3316531 IV - Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 12,700 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 19 |
| 75 mg LY3316531 IV - Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 46,900 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 10 |
| 300 mg LY3316531 IV - Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 25,800 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 27 |
| 300 mg LY3316531 SC- Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 181,000 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 25 |
| 900 mg LY3316531 IV - Part A | Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 319,000 micrograms*hours per milliliter(μg*h/mL) | Geometric Coefficient of Variation 31 |
Secondary
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531 following the Day 57 dose.
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Population: All randomized participants in Part B who received study drug on Day 57 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part A | Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 876 μg/mL | Geometric Coefficient of Variation 14 |
Secondary
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.
Time frame: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85
Population: All randomized participants in Part B who received study drug on Day 57 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part A | Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau | 258,000 μg*h/mL | Geometric Coefficient of Variation 2 |
Secondary
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
PK: Cmax of LY3316531.
Time frame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
Population: All randomized participants in Part C who received study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part A | Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531 | 124 μg/mL | Geometric Coefficient of Variation 19 |
Secondary
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Time frame: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose
Population: All randomized participants in Part C who received study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part A | Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞) | 39,500 μg*h/mL | Geometric Coefficient of Variation 28 |