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| ID | Type | Description | Link |
|---|---|---|---|
| H9P-EW-LNCX | Other Identifier | Eli Lilly and Company |
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This study involves a single dose of 18 milligrams (mg) LY2216684 taken as 1 or 2 tablets by mouth. The study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive Ortho Cyclen®. This study will run approximately 93 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OC + LY2216684 First, Then OC + Placebo | Experimental | 28-day lead-in period of Ortho Cyclen (OC; 28-day packet), followed by randomization to OC administered orally once daily for 28 days + 18 milligrams (mg) of LY2216684 administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days. |
|
| OC + Placebo First, Then OC + LY2216684 | Experimental | 28-day lead-in period of OC (28-day packet), followed by randomization to OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + 18 mg of LY2216684 administered concomitantly orally once daily for 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2216684 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin | The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant. | Predose up to 24 hours post dose on Day 21 |
| Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin | Predose up to 24 hours post dose on Day 21 | |
| Area Under the Concentration-Time Curve Over a Dosing Interval (AUCÏ„) of Ethinyl Estradiol and Norelgestromin | The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant. | Predose up to 24 hours post dose on Day 21 |
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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. | Madison | Wisconsin |
This was a randomized, 2-period, 2-sequence crossover study with a lead-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | OC + LY2216684 / OC + Placebo | Lead-in Period: 28 days of Ortho Cyclen [OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo] Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo |
| FG001 | OC + Placebo / OC + LY2216684 | Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo) Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lead-in Period |
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| Period 1 |
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| Period 2 |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | OC + LY2216684 / OC + Placebo | Lead-in Period: 28 days of Ortho Cyclen [OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo] Period 1: OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo Period 2: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo |
| Units | Counts |
|---|---|
| Participants |
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| 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 Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin | The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant. | All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze Cmax. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | 90% Confidence Interval | picograms/milliliter (pg/mL) | Predose up to 24 hours post dose on Day 21 |
|
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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 | OC Lead-in Period | Lead-in Period: 28 days of Ortho Cyclen [OC; 21 days of 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo] |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system 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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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C568831 | alpha-((5-fluoro-2-methoxyphenyl)methyl)-alpha-(tetrahydro-2H-pyran-4-yl)-2-morpholinemethanol |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Ortho Cyclen | Drug | 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally |
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| Placebo | Drug | Administered orally |
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| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | OC + Placebo / OC + LY2216684 | Lead-in Period: 28 days of OC (21 days of 35 mcg ethinyl estradiol and 250 mcg norgestimate and 7 days of OC placebo) Period 1: OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo Period 2: OC + 18 mg of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences |
|
|
|
| Primary | Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin | All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze tmax. Participants were analyzed based on the treatment they received. | Posted | Median | Full Range | hour (h) | Predose up to 24 hours post dose on Day 21 |
|
|
|
|
| Primary | Area Under the Concentration-Time Curve Over a Dosing Interval (AUCÏ„) of Ethinyl Estradiol and Norelgestromin | The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant. | All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze AUCÏ„. Participants were analyzed based on the treatment they received. | Posted | Geometric Mean | 90% Confidence Interval | picograms*hour/milliliter (pg*hr/mL) | Predose up to 24 hours post dose on Day 21 |
|
|
|
|
| 0 |
| 18 |
| 12 |
| 18 |
| EG001 | OC + LY2216684 | OC + 18 milligrams (mg) of LY2216684 administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences | 0 | 16 | 13 | 16 |
| EG002 | OC + Placebo | OC + LY2216684 placebo administered concomitantly orally, once daily for 21 days and 7 days of OC placebo in both sequences | 0 | 16 | 13 | 16 |
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Change of bowel habit | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Emotional poverty | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Panic reaction | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Menstruation irregular | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Piloerection | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Norelgestromin |
|
|
Median difference is for norelgestromin. |
| Median Difference (Final Values) |
| 0.00 |
| 2-Sided |
| 90 |
| -0.50 |
| 0.50 |
| Superiority or Other |
| Norelgestromin |
|
|
Ratio of Geometric LS mean is for norelgestromin.
| Ratio of Geometric LS Mean |
| 1.00 |
| 90 |
| 0.944 |
| 1.07 |
| Superiority or Other |