A Study of LY2940680 in Healthy Participants
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01681186
Collaborator
(none)
30
1
6
3
10
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A Single Ascending Dose and Relative Bioavailability Study of LY2940680 in Healthy Subjects
Study Start Date
:
Sep 1, 2012
Actual Primary Completion Date
:
Dec 1, 2012
Actual Study Completion Date
:
Dec 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY2940680 (Part A) Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods |
Drug: LY2940680 Capsule(s) (Reference)
Administered orally as a capsule(s)
|
| Placebo Comparator: Placebo (Part A) Placebo given once orally in up to 1 of 2 study periods |
Drug: Placebo Capsule(s)
Administered orally as a capsule(s)
|
| Experimental: LY2940680 Capsule Fasted (Part B) 100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods |
Drug: LY2940680 Capsule(s) (Reference)
Administered orally as a capsule(s)
|
| Experimental: LY2940680 Tablet Fasted (Part B) 100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods |
Drug: LY2940680 Tablet (Test)
Administered orally as a tablet
|
| Experimental: LY2940680 Tablet Fed (Part B) 100 mg LY2940680 given once orally as a tablet (test formulation) in fed state following a standardized, high-fat breakfast in 1 of 4 study periods |
Drug: LY2940680 Tablet (Test)
Administered orally as a tablet
|
| Experimental: LY2940680 Tablet Fasted + PPI (Part B) 30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods |
Drug: LY2940680 Tablet (Test)
Administered orally as a tablet
Drug: Lansoprazole
Administered orally as a capsule
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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: 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)
- 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 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: 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-∞)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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. | Dallas | Texas | United States |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01681186
Other Study ID Numbers:
- 14893
- I4J-MC-HHBG
First Posted:
Sep 7, 2012
Last Update Posted:
Oct 21, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | Part A, Cohort 1, Sequence 1 | Part A, Cohort 1, Sequence 2 | 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 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| Period Title: First Intervention | ||||||||
| STARTED | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 |
| COMPLETED | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: First Intervention | ||||||||
| STARTED | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 |
| COMPLETED | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: First Intervention | ||||||||
| STARTED | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 |
| COMPLETED | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: First Intervention | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 7 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Period Title: First Intervention | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: First Intervention | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Period Title: First Intervention | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 6 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Part A, Cohort 1, Sequence 1 | Part A, Cohort 1, Sequence 2 | 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 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 4 | 2 | 2 | 3 | 3 | 2 | 7 | 7 | 30 |
| Age (Count of Participants) | |||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
4
100%
|
2
100%
|
2
100%
|
3
100%
|
3
100%
|
2
100%
|
7
100%
|
7
100%
|
30
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
4
100%
|
2
100%
|
2
100%
|
2
66.7%
|
3
100%
|
1
50%
|
7
100%
|
7
100%
|
28
93.3%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
50%
|
0
0%
|
0
0%
|
2
6.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
50%
|
4
57.1%
|
4
57.1%
|
10
33.3%
|
| Not Hispanic or Latino |
4
100%
|
2
100%
|
2
100%
|
2
66.7%
|
3
100%
|
1
50%
|
3
42.9%
|
3
42.9%
|
20
66.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
25%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
| Black or African American |
0
0%
|
1
50%
|
0
0%
|
0
0%
|
2
66.7%
|
0
0%
|
2
28.6%
|
2
28.6%
|
7
23.3%
|
| White |
3
75%
|
1
50%
|
2
100%
|
2
66.7%
|
1
33.3%
|
2
100%
|
5
71.4%
|
5
71.4%
|
21
70%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||||||
| United States |
4
100%
|
2
100%
|
2
100%
|
3
100%
|
3
100%
|
2
100%
|
7
100%
|
7
100%
|
30
100%
|
Outcome Measures
| Title | Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants. |
| Arm/Group Title | Placebo Capsule (Fasted) | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) Part A | 100-mg LY2940680 Capsule (Fasted) Part B | 100-mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 Tablet (Fed) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo capsule given once orally in fasted state during Part A of the study. | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor(PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study. | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| Measure Participants | 9 | 6 | 6 | 14 | 14 | 11 | 12 | 6 | 5 |
| Adverse Events (AEs) |
2
50%
|
3
150%
|
4
200%
|
6
200%
|
5
166.7%
|
3
150%
|
5
71.4%
|
3
42.9%
|
3
10%
|
| Serious Adverse Events (SAEs) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants in Part B of the study with evaluable Cmax data. |
| Arm/Group Title | 100-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet (Fed) | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) |
|---|---|---|---|---|
| Arm/Group Description | 100-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study. | 100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor (PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study. |
| Measure Participants | 14 | 14 | 11 | 10 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)] |
879
(49.3)
|
1170
(22.4)
|
776
(26.3)
|
1290
(47.9)
|
| Title | Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. |
| Arm/Group Title | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) |
|---|---|---|---|---|
| Arm/Group Description | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| Measure Participants | 6 | 6 | 6 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)] |
622
(25.3)
|
661
(68.3)
|
1740
(15.6)
|
3360
(32.8)
|
| Title | Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. |
| Arm/Group Title | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) |
|---|---|---|---|---|
| Arm/Group Description | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| Measure Participants | 6 | 6 | 6 | 5 |
| Median (Full Range) [hours (h)] |
1.5
|
2
|
2
|
2
|
| Title | Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study. |
| Arm/Group Title | 100-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet (Fed) | 100-mg LY2940680 Tablet (Fasted) PPI |
|---|---|---|---|---|
| Arm/Group Description | 100-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fed state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. Participants were administered 30 mg lansoprazole (proton pump inhibitor (PPI)) once-daily (QD). |
| Measure Participants | 14 | 14 | 11 | 10 |
| Median (Full Range) [hours (h)] |
1
|
1.5
|
3
|
1
|
| Title | 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)] |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. |
| Arm/Group Title | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) |
|---|---|---|---|---|
| Arm/Group Description | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| Measure Participants | 6 | 6 | 6 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours per milliliter (ng*h/mL)] |
5300
(27.5)
|
9440
(53.9)
|
22800
(21.2)
|
49300
(27.9)
|
| Title | 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)] |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 who had evaluable PK data during Part B of the study. |
| Arm/Group Title | 100-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet (Fed) | 100-mg LY2940680 Tablet (Fasted) PPI |
|---|---|---|---|---|
| Arm/Group Description | 100-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fed state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part A of the study. Participants were administered 30 mg lansoprazole (proton pump inhibitor (PPI)) once-daily (QD). |
| Measure Participants | 14 | 14 | 11 | 10 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours per milliliter (ng*h/mL)] |
9390
(41.1)
|
10300
(39.9)
|
11200
(37.2)
|
9980
(50.1)
|
| Title | Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study. |
| Arm/Group Title | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) |
|---|---|---|---|---|
| Arm/Group Description | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. |
| Measure Participants | 6 | 6 | 6 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours per milliliter (ng*h/mL)] |
5340
(27.4)
|
9530
(54.0)
|
23000
(21.6)
|
49800
(28.3)
|
| Title | Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study. |
| Arm/Group Title | 100-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet (Fed) | 100-mg LY2940680 Tablet (Fasted) PPI |
|---|---|---|---|---|
| Arm/Group Description | 100-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fed state during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. Participants were administered 30 mg lansoprazole (proton pump inhibitor (PPI)) once-daily (QD). |
| Measure Participants | 14 | 14 | 11 | 10 |
| Geometric Mean (Geometric Coefficient of Variation) [nanograms*hours per milliliter (ng*h/mL)] |
9460
(41.3)
|
10300
(40.1)
|
11300
(37.3)
|
10000
(50.1)
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Placebo Capsule (Fasted) | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) Part A or Part B | 100 mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 Tablet (Fed) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) | ||||||||
| Arm/Group Description | Placebo capsule given once orally in fasted state during Part A of the study. | 50-milligram (mg) LY2940680 capsule administered once orally in fasted state during Part A of the study. | 100-mg LY2940680 capsule administered once orally in fasted state during Part A or Part B of the study. | 100-mg LY2940680 tablet administered once orally in fasted state during Part B of the study. | 100-mg LY2940680 tablet administered in fasted state with a 7-day lead-in phase of once-daily 30-mg lansoprazole [proton pump inhibitor (PPI)] followed by 100-mg LY2940680 tablet administered 1 hour after the last dose of lansoprazole during Part B of the study. | 100-mg LY2940680 tablet administered once orally in fed state following standardized, high-fat breakfast during Part B of the study. | 200-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | 400-mg LY2940680 capsule administered once orally in fasted state during Part A of the study. | ||||||||
All Cause Mortality |
||||||||||||||||
| Placebo Capsule (Fasted) | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) Part A or Part B | 100 mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 Tablet (Fed) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Placebo Capsule (Fasted) | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) Part A or Part B | 100 mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 Tablet (Fed) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/6 (0%) | 0/20 (0%) | 0/14 (0%) | 0/11 (0%) | 0/12 (0%) | 0/6 (0%) | 0/5 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Placebo Capsule (Fasted) | 50-mg LY2940680 Capsule (Fasted) | 100-mg LY2940680 Capsule (Fasted) Part A or Part B | 100 mg LY2940680 Tablet (Fasted) | 100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted) | 100-mg LY2940680 Tablet (Fed) | 200-mg LY2940680 Capsule (Fasted) | 400-mg LY2940680 Capsule (Fasted) | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/9 (22.2%) | 3/6 (50%) | 10/20 (50%) | 5/14 (35.7%) | 3/11 (27.3%) | 5/12 (41.7%) | 3/6 (50%) | 3/5 (60%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Constipation | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Diarrhoea | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 1/14 (7.1%) | 1 | 0/11 (0%) | 0 | 1/12 (8.3%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Dry mouth | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Eructation | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Nausea | 1/9 (11.1%) | 1 | 1/6 (16.7%) | 1 | 2/20 (10%) | 2 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 1/12 (8.3%) | 1 | 2/6 (33.3%) | 2 | 0/5 (0%) | 0 |
| Vomiting | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 3 | 0/14 (0%) | 0 | 1/11 (9.1%) | 1 | 1/12 (8.3%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| General disorders | ||||||||||||||||
| Facial pain | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 1/11 (9.1%) | 1 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Fatigue | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 1/12 (8.3%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Feeling cold | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Pain | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 1/11 (9.1%) | 1 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Immune system disorders | ||||||||||||||||
| Seasonal allergy | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 1/11 (9.1%) | 1 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Infections and infestations | ||||||||||||||||
| Tooth infection | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/14 (7.1%) | 1 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||||||
| Excoriation | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 1/12 (8.3%) | 1 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Muscle spasms | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 2/5 (40%) | 4 |
| Neck mass | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 1/11 (9.1%) | 1 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Nervous system disorders | ||||||||||||||||
| Dizziness | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 3/20 (15%) | 3 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Headache | 2/9 (22.2%) | 2 | 1/6 (16.7%) | 1 | 6/20 (30%) | 6 | 3/14 (21.4%) | 3 | 0/11 (0%) | 0 | 3/12 (25%) | 4 | 3/6 (50%) | 3 | 1/5 (20%) | 1 |
| Paraesthesia | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 1/6 (16.7%) | 1 | 0/5 (0%) | 0 |
| Somnolence | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 1/14 (7.1%) | 1 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||||||
| Vulvovaginal pruritus | 0/8 (0%) | 0 | 0/6 (0%) | 0 | 1/19 (5.3%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/3 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Nasal congestion | 0/9 (0%) | 0 | 1/6 (16.7%) | 1 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 1/5 (20%) | 1 |
| Throat irritation | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Dry skin | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/14 (7.1%) | 2 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Pruritus | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 5 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Rash | 0/9 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 5 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
| Vascular disorders | ||||||||||||||||
| Flushing | 0/9 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/14 (0%) | 0 | 0/11 (0%) | 0 | 0/12 (0%) | 0 | 0/6 (0%) | 0 | 0/5 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
| ClinicalTrials.gov@lilly.com |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01681186
Other Study ID Numbers:
- 14893
- I4J-MC-HHBG
First Posted:
Sep 7, 2012
Last Update Posted:
Oct 21, 2019
Last Verified:
Sep 1, 2019