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| ID | Type | Description | Link |
|---|---|---|---|
| I1V-MC-EIAP | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones found in the blood will be measured and compared when taken alone and when taken with evaceptrapib. Each woman will participate in two study periods. Information about any side effects that may occur will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ortho-Cyclen | Experimental | Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods. Treatment A |
|
| Ortho-Cyclen + Evacetrapib | Experimental | Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods. Treatment B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ortho-Cyclen | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Maximum Concentration (Cmax) of Norelgestromin | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose | |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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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. | Dallas | Texas | 75247 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ortho-Cyclen | Ortho-Cyclen (OC) of (35 microgram [mcg] ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD) for 28 days (Days 1 to 28) |
| FG001 | Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB | Treatment A OC administered orally, QD for 28 days (Days 1 to 28) Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 milligram (mg) Evacetrapib orally, QD for 21 days (Days 1 to 21) |
| FG002 | Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA | Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, QD for 21 days (Days 1 to 21) Treatment A OC administered orally, QD for 28 days (Days 1 to 28) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead-In Period |
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| Period 1 |
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| Period 2 |
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Twenty-two subjects received at least one dose of study drug and are included in the summary of subject demographics
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| ID | Title | Description |
|---|---|---|
| BG000 | Ortho-Cyclen and Ortho-Cyclen + Evacetrapib | Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, QD for 28 days (lead-in period). Treatment A Ortho-Cyclen administered orally, QD for 28 Days (Days 1 to 28) Treatment B Ortho-Cyclen orally, QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD for 21 days (Days 1 to 21) |
| 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 (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram per milliliter (pg/ml) | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
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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 | Ortho-Cyclen (Lead-in Phase) | Ortho-Cyclen oral doses of (35 mcg ethinyl estradiol and 250 mcg norgestimate) once daily for 28 days (Days 1 to 28) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C568301 | evacetrapib |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Evacetrapib |
| Drug |
Oral administration |
|
|
| United States |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram x hour per ml (pg*hour/ml) | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| Primary | PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hour | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| Primary | PK: Maximum Concentration (Cmax) of Norelgestromin | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| Primary | PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*hour/ml | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| Primary | PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| Primary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hour | Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose |
|
|
|
| 0 |
| 22 |
| 9 |
| 22 |
| EG001 | Ortho-Cyclen | Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) in one of two treatment periods. Ortho-Cyclen: Oral administration | 0 | 17 | 5 | 17 |
| EG002 | Ortho-Cyclen + Evacetrapib | Ortho-Cyclen administered orally for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally for 21 days (Days 1 to 21) in one of two treatment periods. Ortho-Cyclen: Oral administration Evacetrapib: Oral administration | 0 | 21 | 5 | 21 |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |