Healthy Participants
Conditions
Brief summary
This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the safety and side effects of LY2940680 in healthy participants. Part A will involve two groups of participants, each taking up to two single doses of LY2940680 at different dose levels. There is a minimum 14 day washout period between each of the participant's doses. The purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets into the bloodstream and how long the body takes to get rid of it. In addition, the effect of food and a proton pump inhibitor (PPI) on LY2940680 will be studied. Part B will involve one group of participants who will take four single doses of 100 milligrams (mg) LY2940680. There is a minimum 7 day washout period between doses. Participants may only enroll in one part. Screening is required within 28 days prior to the start of the study.
Interventions
DRUGLY2940680 Capsule(s) (Reference)
Administered orally as a capsule(s)
DRUGLY2940680 Tablet (Test)
Administered orally as a tablet
DRUGLansoprazole
Administered orally as a capsule
Administered orally as a capsule(s)
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and physical examination * Body mass index of 18.5 to 32.0 kilograms per meter square (kg/m\^2) * Have clinical laboratory test results within normal reference range * Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site * Prepared to eat an entire high fat breakfast
Exclusion criteria
* Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product * Have known allergies to LY2940680, related compounds or any components of the formulation, or known allergies to lansoprazole (Part B only) * Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product. Participants in Part A are not allowed to participate in Part B * Have an abnormality in the 12-lead electrocardiogram (ECG) * 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 study medication; or of interfering with the interpretation of data (cholecystectomy or appendectomy are allowed if surgery at least 6 months prior to screening) * 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 C and/or positive hepatitis C antibody * Show evidence of hepatitis B and/or positive hepatitis B surface antigen * Have used or intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study. Exception: participants may continue hormone replacement therapy (HRT; estrogen) * Use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or Starfruit within 7 days prior to dosing or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B) | Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section. |
| Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug | The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) |
| Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug | Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration \[AUC(0-tlast)\] |
| Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug | The Cmax of LY2940680 during Part A of the study was reported. |
| Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity \[AUC(0-∞)\] |
| Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity \[AUC(0-∞)\] |
| Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug | Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration \[AUC(0-tlast)\] |
| Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) |
Countries
United States
Participant flow
Pre-assignment details
This randomized single-dose study consisted of 2 parts. Part A had Cohorts 1 and 2 receive ascending doses of LY2940680 and placebo over 2 periods. Part B had Cohort 3 receive 1 of 2 treatment sequences over 4 separate periods to evaluate tablet versus capsule (reference) formulation, and the effects of food and proton pump inhibitor (PPI).
Participants by arm
| Arm | Count |
|---|---|
| Part A, Cohort 1, Sequence 1 50-milligram (mg) LY2940680 capsule in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study | 4 |
| Part A, Cohort 1, Sequence 2 50-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. | 2 |
| Part A, Cohort 1, Sequence 3 Placebo in fasted state in Period 1 followed by 200-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. | 2 |
| Part A, Cohort 2, Sequence 4 100-mg LY2940680 capsule in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. | 3 |
| Part A, Cohort 2, Sequence 5 100-mg LY2940680 capsule in fasted state in Period 1 followed by Placebo in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. | 3 |
| Part A, Cohort 2, Sequence 6 Placebo in fasted state in Period 1 followed by 400-mg LY2940680 capsule in fasted state in Period 2. There was a washout period of at least 14 days between doses in Part A of the study. | 2 |
| Part B, Cohort 3, Sequence 1 100-mg LY2940680 capsule in fasted state in Period 1, then100-mg LY2940680 tablet in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study. | 7 |
| Part B, Cohort 3, Sequence 2 100-mg LY2940680 tablet in fasted state in Period 1, then 100-mg LY2940680 capsule in fasted state in Period 2, then 100-mg LY2940680 tablet in fed state following standardized, high-fat breakfast in Period 3, and then 100-mg LY2940680 tablet and 30-mg lansoprazole capsule in fasted state in Period 4. There was a washout period of at least 7 days between doses in Part B of the study. | 7 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Fourth Intervention | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Washout Period From Second Intervention | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Washout Period From Second Intervention | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Washout Period From Third Intervention | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Part A, Cohort 1, Sequence 2 | Part A, Cohort 1, Sequence 1 | Part A, Cohort 1, Sequence 3 | Part A, Cohort 2, Sequence 4 | Part A, Cohort 2, Sequence 5 | Part A, Cohort 2, Sequence 6 | Part B, Cohort 3, Sequence 1 | Part B, Cohort 3, Sequence 2 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 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 |
| Age, Categorical Between 18 and 65 years | 30 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 7 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 3 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 |
| 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 |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 |
| Race (NIH/OMB) White | 21 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 30 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Female | 28 Participants | 2 Participants | 4 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 9 | 3 / 6 | 10 / 20 | 5 / 14 | 3 / 11 | 5 / 12 | 3 / 6 | 3 / 5 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 | 0 / 20 | 0 / 14 | 0 / 11 | 0 / 12 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.
Time frame: Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)
Population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 2 Participants |
| Placebo Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 50-mg LY2940680 Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 50-mg LY2940680 Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 3 Participants |
| 100-mg LY2940680 Capsule (Fasted) Part A | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 100-mg LY2940680 Capsule (Fasted) Part A | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 4 Participants |
| 100-mg LY2940680 Capsule (Fasted) Part B | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 6 Participants |
| 100-mg LY2940680 Capsule (Fasted) Part B | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 100-mg LY2940680 Tablet (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 5 Participants |
| 100-mg LY2940680 Tablet (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 3 Participants |
| 100-mg LY2940680 Tablet (Fed) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 5 Participants |
| 100-mg LY2940680 Tablet (Fed) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 200-mg LY2940680 Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 3 Participants |
| 200-mg LY2940680 Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
| 400-mg LY2940680 Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Adverse Events (AEs) | 3 Participants |
| 400-mg LY2940680 Capsule (Fasted) | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs | Serious Adverse Events (SAEs) | 0 Participants |
Primary
Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation
The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug
Population: Analysis was based on the number of randomized participants in Part B of the study with evaluable Cmax data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule (Fasted) | Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | 879 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 49.3 |
| 50-mg LY2940680 Capsule (Fasted) | Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | 1170 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 22.4 |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | 776 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 26.3 |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation | 1290 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 47.9 |
Secondary
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity \[AUC(0-∞)\]
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule (Fasted) | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 5340 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 27.4 |
| 50-mg LY2940680 Capsule (Fasted) | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 9530 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 54 |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 23000 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 21.6 |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 49800 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 28.3 |
Secondary
Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration \[AUC(0-tlast)\]
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule (Fasted) | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 5300 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 27.5 |
| 50-mg LY2940680 Capsule (Fasted) | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 9440 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 53.9 |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 22800 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 21.2 |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 49300 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 27.9 |
Secondary
Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)
The Cmax of LY2940680 during Part A of the study was reported.
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule (Fasted) | Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | 622 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 25.3 |
| 50-mg LY2940680 Capsule (Fasted) | Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | 661 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 68.3 |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | 1740 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 15.6 |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) | 3360 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 32.8 |
Secondary
Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)
Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Capsule (Fasted) | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 1.5 hours (h) |
| 50-mg LY2940680 Capsule (Fasted) | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 2 hours (h) |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 2 hours (h) |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 2 hours (h) |
Secondary
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity \[AUC(0-∞)\]
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule (Fasted) | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 9460 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 41.3 |
| 50-mg LY2940680 Capsule (Fasted) | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 10300 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 40.1 |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 11300 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 37.3 |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] | 10000 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 50.1 |
Secondary
Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration \[AUC(0-tlast)\]
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 who had evaluable PK data during Part B of the study.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Capsule (Fasted) | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 9390 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 41.1 |
| 50-mg LY2940680 Capsule (Fasted) | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 10300 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 39.9 |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 11200 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 37.2 |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)] | 9980 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 50.1 |
Secondary
Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)
Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug
Population: Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Capsule (Fasted) | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 1 hours (h) |
| 50-mg LY2940680 Capsule (Fasted) | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 1.5 hours (h) |
| 100-mg LY2940680 Capsule (Fasted) Part A | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 3 hours (h) |
| 100-mg LY2940680 Capsule (Fasted) Part B | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) | 1 hours (h) |