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| ID | Type | Description | Link |
|---|---|---|---|
| I3G-FW-JGCE | Other Identifier | Eli Lilly and Company |
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This is a single-centre, placebo-controlled, two-part study in healthy participants.
Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: 25 mg RF | Experimental | A single 25 mg dose of LY2584702 RF |
|
| Part A: Placebo | Placebo Comparator | Placebo taken orally |
|
| Part B: Sequence 1 | Experimental | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
|
| Part B: Sequence 2 | Experimental | Placebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
|
| Part B: Sequence 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2584702 Reference Formulation | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) | The Cmax following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported. | Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose] |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) | AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)] and AUC from time 0 to infinity [AUC(0-inf)] following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported. | Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose] |
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Inclusion Criteria:
Male participants:
• Agree to use a reliable method of birth control during the study and for at least 1 month following the last dose of study drug
Female participants:
• Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to 45 years old, who have not taken hormones or oral contraceptives within the last year, and had cessation of menses for at least 1 year, or who have had 6 to 12 months of amenorrhea with follicle-stimulating hormone (FSH) levels consistent with postmenopausal state.
All participants:
Exclusion Criteria
All participants:
Applicable for Part A only:
• have known allergies to lignocaine, adrenaline, tetracycline, or related compounds, which will be used in the skin biopsy procedure
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore |
Part A: single period, single dose pilot assessed safety, tolerability. Part B: 4-period crossover evaluated bioavailability of 2 drug formulations. Part B, Period (P) 4 participants (pts) separated into 2 cohorts, received drug under fed (P4a) or fasted (P4b) conditions. Pts who withdrew or were withdrawn prior to completing P3 were replaced.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2584702 | Participants enrolled in Part A of the study received a single dose of 25 milligrams (mg) LY2584702 (LY) reference formulation [RF (capsule)] in a fasted state on Day 1. |
| FG001 | Placebo | Participants enrolled in Part A of the study received placebo in a fasted state on Day 1. |
| FG002 | 10 mg LY TF, Placebo, 50 mg LY TF, 50 mg LY TF Fed | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 test formulation [TF (tablet)], placebo, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods. |
| FG003 | Placebo, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed | Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods. |
| FG004 | Placebo, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted | Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| FG005 | 10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods. |
| FG006 | 10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| FG007 | 10 mg LY TF, 50 mg LY RF, 50 mg LY TF, Placebo Fasted | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and placebo in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| FG008 | 10 mg LY TF, 50 mg LY RF, Placebo, 200 mg LY TF Fasted | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and placebo in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| FG009 | 200 mg LY TF Fasted | Participant enrolled in Part B, Period 4b of the study received a single dose of 200 mg LY2584702 TF in a fasted state on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Period 1) |
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| Washout Period 1 |
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| Second Intervention (Period 2) |
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| Washout Period 2 |
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| Third Intervention (Period 3) |
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| Washout Period 3 |
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| Forth Intervention (Period 4a/4b) |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A (LY2584702) | Participants enrolled in Part A of the study received a single dose of 25 milligrams (mg) LY2584702 (LY) reference formulation [RF (capsule)] in a fasted state on Day 1. |
| BG001 | Part A (Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) | The Cmax following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported. | Randomized participants in Part A or B of the study who had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose] |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo orally in fasted state on Day 1 in Part A and Periods 1 to 4, Day 1 in Part B of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| Experimental |
A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
|
| Part B: Sequence 4 | Experimental | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
|
| LY2584702 Test Formulation | Drug | Administered orally |
|
| Placebo | Drug | Administered orally |
|
| Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol) | Baseline-adjusted change-from-predose in lipid concentrations were measured to assess the LY2584702 effect on lipids under different fed states. The 50-milligram (mg) LY2584702 test formulation [TF (tablet)] was the only dose and formulation administered in both the fasted and fed states for comparison. Therefore, changes in total cholesterol after single oral doses of placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 reference formulation [RF (capsule)] were not calculated. The baseline-adjusted change-from-predose in total cholesterol levels in the fasted and fed state following a single 50-mg LY2584702 TF dose is reported. Baseline was Day -1 of Period 1 for Period 3 fasted state and baseline was Day -1 of Period 4a for Period 4a fed state. Least squares (LS) means was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, time, treatment by time, and participant. | Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h. |
| Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1 | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 reference formulation [RF (capsule)] were administered in a fasted state are reported at baseline (Day 1, Predose) and 3 hours (h), 4 h, 6 h, and 24 h postdose. | Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose) |
| Part B: Average Time-Matched QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1 | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 test formulation [TF (tablet)], LY2584702 reference formulation [RF (capsule)], or placebo were administered in a fasted or fed state are reported at baseline (time-matched Day -1 QTcF) and 3 hours (h), 4 h, 6 h, and 24 h postdose. Day 1, Hour 24 was time-matched with Day-1, Hour 0. | Part B: Baseline [Period 1 (Day -1)] and Periods 1 to 4 (Day 1). Electrocardiograms (ECG) were performed at time point 0 and 3 h, 4 h, 6 h, and 24 h. |
| Singapore |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
Participants enrolled in Part A of the study received placebo in a fasted state on Day 1.
| BG002 | 10 mg LY TF, Placebo, 50 mg LY TF, 50 mg LY TF Fed | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 test formulation [TF (tablet)], placebo, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods. |
| BG003 | Placebo, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed | Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods. |
| BG004 | Placebo, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted | Participants enrolled in Part B of the study received a single dose of placebo, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| BG005 | 10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 50 mg LY TF Fed | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 50 mg LY2584702 TF in a fed state in Period 4a, Day 1. There was a washout of at least 3 days between periods. |
| BG006 | 10 mg LY TF, 50 mg LY RF, 50 mg LY TF, 200 mg LY TF Fasted | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| BG007 | 10 mg LY TF, 50 mg LY RF, 50 mg LY TF, Placebo Fasted | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and 50 mg LY2584702 TF in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and placebo in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| BG008 | 10 mg LY TF, 50 mg LY RF, Placebo, 200 mg LY TF Fasted | Participants enrolled in Part B of the study received a single dose of 10 mg LY2584702 TF, 50 mg LY2584702 RF, and placebo in a fasted state, on Day 1 of Periods 1, 2, and 3, respectively and 200 mg LY2584702 TF in a fasted state in Period 4b, Day 1. There was a washout of at least 3 days between periods. |
| BG009 | 200 mg LY TF Fasted | Participant enrolled in Part B, Period 4b of the study received a single dose of 200 mg LY2584702 TF in a fasted state on Day 1. |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 10 mg of LY2584702 TF orally in a fasted state, in Period 1, Day 1 of Part B of the study.
| OG002 | 50 mg LY2584702 RF Fasted | Participants received 50 mg of LY2584702 RF orally in a fasted state, in Period 2, Day 1 of Part B of the study. |
| OG003 | 50 mg LY2584702 TF Fasted | Participants received 50 mg of LY2584702 TF orally in a fasted state, in Period 3, Day 1 of Part B of the study. |
| OG004 | 50 mg LY2584702 TF Fed | Participants received 50 mg of LY2584702 TF orally in a fed state, in Period 4a, Day 1 of Part B of the study. |
| OG005 | 200 mg LY2584702 TF Fasted | Participants received 200 mg of LY2584702 TF orally in a fasted state, in Period 4b, Day 1 of Part B of the study. |
|
|
| Secondary | Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) | AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)] and AUC from time 0 to infinity [AUC(0-inf)] following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported. | Randomized participants in Part A or B of the study who had evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose] |
|
|
|
| Secondary | Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol) | Baseline-adjusted change-from-predose in lipid concentrations were measured to assess the LY2584702 effect on lipids under different fed states. The 50-milligram (mg) LY2584702 test formulation [TF (tablet)] was the only dose and formulation administered in both the fasted and fed states for comparison. Therefore, changes in total cholesterol after single oral doses of placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 reference formulation [RF (capsule)] were not calculated. The baseline-adjusted change-from-predose in total cholesterol levels in the fasted and fed state following a single 50-mg LY2584702 TF dose is reported. Baseline was Day -1 of Period 1 for Period 3 fasted state and baseline was Day -1 of Period 4a for Period 4a fed state. Least squares (LS) means was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, time, treatment by time, and participant. | Randomized participants (pts) in Part B of study who had both baseline and postdose total cholesterol measurements. Pts not analyzed for baseline-adjusted change-from-predose total cholesterol levels after single dose placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 RF since they weren't administered in both fasted and fed state. | Posted | Least Squares Mean | 90% Confidence Interval | milligrams per deciliter (mg/dL) | Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h. |
|
|
|
| Secondary | Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1 | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 reference formulation [RF (capsule)] were administered in a fasted state are reported at baseline (Day 1, Predose) and 3 hours (h), 4 h, 6 h, and 24 h postdose. | Randomized participants in Part A of the study who had both baseline and postdose ECG assessments at each time point. Data was not collected for Placebo group due to insufficient participants (N=2). | Posted | Mean | Standard Deviation | milliseconds (ms) | Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose) |
|
|
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| Secondary | Part B: Average Time-Matched QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1 | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 test formulation [TF (tablet)], LY2584702 reference formulation [RF (capsule)], or placebo were administered in a fasted or fed state are reported at baseline (time-matched Day -1 QTcF) and 3 hours (h), 4 h, 6 h, and 24 h postdose. Day 1, Hour 24 was time-matched with Day-1, Hour 0. | Randomized participants in Part B of the study who had both baseline and postdose ECG assessments at each time point. | Posted | Mean | Standard Deviation | milliseconds (ms) | Part B: Baseline [Period 1 (Day -1)] and Periods 1 to 4 (Day 1). Electrocardiograms (ECG) were performed at time point 0 and 3 h, 4 h, 6 h, and 24 h. |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | 25 mg LY2584702 RF Fasted | Participants received a 25 milligram (mg) LY2584702 reference formulation [RF (capsule)] orally in a fasted state on Day 1 in Part A of the study. | 0 | 8 | 6 | 8 |
| EG002 | 10 mg LY2584702 TF Fasted | Participants received 10 mg of LY2584702 test formulation [TF (tablet)] orally in a fasted state, in Period 1, Day 1 of Part B of the study. | 0 | 12 | 5 | 12 |
| EG003 | 50 mg LY2584702 RF Fasted | Participants received 50 mg of LY2584702 RF orally in a fasted state, in Period 2, Day 1 of Part B of the study. | 0 | 14 | 3 | 14 |
| EG004 | 50 mg LY2584702 TF Fasted | Participants received 50 mg of LY2584702 TF orally in a fasted state, in Period 3, Day 1 of Part B of the study. | 0 | 16 | 2 | 16 |
| EG005 | 50 mg LY2584702 TF Fed | Participants received 50 mg of LY2584702 TF orally in a fed state, in Period 4a, Day 1 of Part B of the study. | 0 | 8 | 4 | 8 |
| EG006 | 200 mg LY2584702 TF Fasted | Participants received 200 mg of LY2584702 TF orally in a fasted state, in Period 4b, Day 1 of Part B of the study. | 0 | 7 | 4 | 7 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| AUC(0-inf) |
|
| 4-hours postdose |
|
| 6-hours postdose |
|
| 10-hours postdose |
|
| 24-hours postdose |
|
| Title | Measurements |
|---|---|
|
| 6-hours postdose |
|
| 24-hours postdose |
|
| Day 1, Hour 0 |
|
| Day-1, Hour 3 (time-matched baseline) |
|
| Day 1, Hour 3 |
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| Day-1, Hour 4 (time-matched baseline) |
|
| Day 1, Hour 4 |
|
| Day-1, Hour 6 (time-matched baseline) |
|
| Day 1, Hour 6 |
|
| Day 1, Hour 24 |
|