Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Melanoma, Neoplasm Metastasis, Neoplasms
Conditions
Brief summary
The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.
Interventions
DRUGLY3009120 capsule
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic cancer * Other available therapies have failed to cure the cancer * The cancer that has no proven effective therapy * The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required) * Able to swallow capsules
Exclusion criteria
* Have active cancer in the brain or spinal cord * Have an active infection of any kind (fungal, viral, or bacterial) * Have a cancer of the blood * Are pregnant or breastfeeding * Have some types of eye problems or impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of LY3009120 | Cycle 1 (28 Days) | Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose | PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1. |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15. |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28. |
| Number of Participants With Tumor Response | Baseline through progressive disease (Up to 7.36 months) | Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15 | Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state \[AUC0-τ\]. |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28 | Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\]. |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose | PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1. |
Countries
Australia, France, Spain, United States
Participant flow
Pre-assignment details
The study consisted of two parts: Part A, a dose escalation phase to determine recommend Phase 2 dose. During Part A, safety data will be assessed and used as primary criteria for dose escalation. Part B, a tumor-specific expansion of treatment groups (cohorts) for dose confirmation.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase | 3 |
| Cohort 2 100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase | 4 |
| Cohort 3 200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase | 3 |
| Cohort 4 400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase | 7 |
| Cohort 5 500 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase | 2 |
| Cohort 6 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Escalation Phase | 16 |
| Cohort A 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase | 1 |
| Cohort B 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase | 5 |
| Cohort C 300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
Dose Confirmation Phase | 10 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Progressive Disease | 3 | 4 | 2 | 6 | 1 | 13 | 1 | 3 | 7 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal Caregiver Decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort B | Cohort C | Total | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | Cohort A |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 15 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 6 Participants | 36 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 2 Participants | 13 Participants | 1 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 |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 49 Participants | 3 Participants | 4 Participants | 3 Participants | 7 Participants | 2 Participants | 14 Participants | 1 Participants |
| Region of Enrollment Australia | 2 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment France | 0 participants | 8 participants | 11 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants | 0 participants |
| Region of Enrollment Spain | 0 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants |
| Region of Enrollment United States | 3 participants | 2 participants | 36 participants | 3 participants | 4 participants | 3 participants | 7 participants | 2 participants | 11 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 28 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 1 Participants | 9 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 23 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 7 Participants | 1 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 |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 2 / 4 | 1 / 3 | 5 / 7 | 0 / 2 | 4 / 16 | 1 / 1 | 4 / 5 | 4 / 10 |
| other Total, other adverse events | 3 / 3 | 4 / 4 | 3 / 3 | 7 / 7 | 2 / 2 | 16 / 16 | 1 / 1 | 5 / 5 | 9 / 10 |
| serious Total, serious adverse events | 0 / 3 | 2 / 4 | 1 / 3 | 5 / 7 | 1 / 2 | 12 / 16 | 1 / 1 | 5 / 5 | 6 / 10 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) of LY3009120
Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
Time frame: Cycle 1 (28 Days)
Population: All participants in Part A who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A LY3009120 | Maximum Tolerated Dose (MTD) of LY3009120 | 300 milligrams (mg) |
Secondary
Number of Participants With Tumor Response
Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Time frame: Baseline through progressive disease (Up to 7.36 months)
Population: All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A LY3009120 | Number of Participants With Tumor Response | Progressive Disease | 1 participants |
| Part A LY3009120 | Number of Participants With Tumor Response | Stable Disease | 0 participants |
| Part A LY3009120 | Number of Participants With Tumor Response | Complete Repsonse | 0 participants |
| Part A LY3009120 | Number of Participants With Tumor Response | Partial Response | 0 participants |
| Part A LY3009120 | Number of Participants With Tumor Response | Not Assessed | 0 participants |
| Cohort B | Number of Participants With Tumor Response | Stable Disease | 0 participants |
| Cohort B | Number of Participants With Tumor Response | Complete Repsonse | 0 participants |
| Cohort B | Number of Participants With Tumor Response | Partial Response | 0 participants |
| Cohort B | Number of Participants With Tumor Response | Progressive Disease | 4 participants |
| Cohort B | Number of Participants With Tumor Response | Not Assessed | 1 participants |
| Cohort C | Number of Participants With Tumor Response | Not Assessed | 4 participants |
| Cohort C | Number of Participants With Tumor Response | Progressive Disease | 1 participants |
| Cohort C | Number of Participants With Tumor Response | Complete Repsonse | 0 participants |
| Cohort C | Number of Participants With Tumor Response | Stable Disease | 5 participants |
| Cohort C | Number of Participants With Tumor Response | Partial Response | 0 participants |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state \[AUC0-τ\].
Time frame: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 15, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15 | 2240 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 1310 |
| Cohort B | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15 | 3520 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 7920 |
| Cohort C | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15 | 5140 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 6260 |
| 300 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15 | 8460 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 60 |
| 400 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15 | 5440 nanogram*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 17 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\].
Time frame: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28 | 3120 ng*hr/mL | Geometric Coefficient of Variation 1300 |
| Cohort B | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28 | 3100 ng*hr/mL | Geometric Coefficient of Variation 102 |
| Cohort C | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28 | 5200 ng*hr/mL | Geometric Coefficient of Variation 7 |
| 300 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28 | 6580 ng*hr/mL | Geometric Coefficient of Variation 47 |
| 400 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28 | 4640 ng*hr/mL | Geometric Coefficient of Variation 18 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1
PK: area under the concentration versus time curve \[0-∞\] of LY3009120 after a single oral dose Cycle 1 Day1.
Time frame: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | 960 nanogram times hour/milliliter(ng*hr/mL) | Geometric Coefficient of Variation 1540 |
| Cohort B | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | 2360 nanogram times hour/milliliter(ng*hr/mL) | Geometric Coefficient of Variation 56 |
| Cohort C | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | 4640 nanogram times hour/milliliter(ng*hr/mL) | Geometric Coefficient of Variation 28 |
| 300 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | 7560 nanogram times hour/milliliter(ng*hr/mL) | Geometric Coefficient of Variation 47 |
| 400 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | 5910 nanogram times hour/milliliter(ng*hr/mL) | Geometric Coefficient of Variation 23 |
| 500 mg LY3009120 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1 | 16,400 nanogram times hour/milliliter(ng*hr/mL) | — |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.
Time frame: Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Population: All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | 420.3 ng/mL | Geometric Coefficient of Variation 241.2 |
| Cohort B | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | 515 ng/mL | Geometric Coefficient of Variation 75 |
| Cohort C | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | 704.74 ng/mL | Geometric Coefficient of Variation 1267.39 |
| 300 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | 1430 ng/mL | Geometric Coefficient of Variation 66 |
| 400 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15 | 775 ng/mL | Geometric Coefficient of Variation 19 |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1
PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.
Time frame: Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose
Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | 105.29 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 228.24 |
| Cohort B | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | 436 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 96 |
| Cohort C | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | 675 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 81 |
| 300 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | 976 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 72 |
| 400 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | 688 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 46 |
| 500 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1 | 1717.76 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 1464.86 |
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
Time frame: Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
Population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | 587.75 ng/mL | Geometric Coefficient of Variation 206.15 |
| Cohort B | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | 550 ng/mL | Geometric Coefficient of Variation 113 |
| Cohort C | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | 594 ng/mL | Geometric Coefficient of Variation 32 |
| 300 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | 1150 ng/mL | Geometric Coefficient of Variation 69 |
| 400 mg LY3009120 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28 | 670 ng/mL | Geometric Coefficient of Variation 30 |