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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHBU | Other Identifier | Eli Lilly and Company |
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This study is known as a "drug interaction study." The purpose is to learn about how ixekizumab may affect the blood levels of a mixture of commonly used drugs (caffeine, omeprazole, warfarin, dextromethorphan, and midazolam) that are metabolized by cytochrome P450. Each participant will complete two study periods. Participants will take the mixture of commonly used drugs (plus vitamin K) by mouth on 3 occasions (prior to treatment with ixekizumab and after 1 and 12 weeks of treatment with ixekizumab). The study will last about 17 weeks, including follow-up. Screening must be completed prior to study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Cocktail | Experimental | Drug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally once in Period 1 (day 1). |
|
| Drug Cocktail + Ixekizumab | Experimental | Drug cocktail (caffeine, warfarin [plus vitamin K], omeprazole, dextromethorphan, and midazolam) administered orally twice in Period 2 (day 8 and day 85). Ixekizumab administered subcutaneously (SC) on multiple occasions in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Cocktail | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Midazolam) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin) | Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Warfarin) | Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan) | Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Avail Clinical Research LLC |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of Ixekizumab in Participants with Plaque Psoriasis | View source |
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Multicenter, open-label, 2-period, fixed-sequence study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Cocktail /Drug Cocktail + Ixekizumab | Period 1: Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin [plus vitamin K], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1. Participants resided at the Clinical Research Unit (CRU) until Day 2, and were discharged following collection of 24-hour pharmacokinetics (PK) samples for the determination of plasma concentrations of the cocktail drugs and metabolites. Period 2: Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Drug Cocktail) |
| ||||||||||||||||
| Period 2 (Drug Cocktail + Ixekizumab) |
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All enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants received drug cocktail and drug cocktail + Ixekizumab. |
| 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 Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose |
|
Up To 89 days
All enrolled participants who received at least 1 dose of study drug.
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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 | Drug Cocktail | Participants received drug cocktail (100 mg Caffeine, 10 mg Warfarin [plus vitamin K], 20 mg Omeprazole, 30 mg Dextromethorphan, and 1 mg Midazolam) administered orally on Day 1 of period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2016 | Oct 25, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2017 | Oct 25, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| D014859 | Warfarin |
| D009853 | Omeprazole |
| D003915 | Dextromethorphan |
| D008874 | Midazolam |
| C549079 | ixekizumab |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Ixekizumab | Drug | Administered SC |
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Dextromethorphan) |
| Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC[0-48h]) of CYP450 Substrate (Caffeine) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
| DeLand |
| Florida |
| 32720 |
| United States |
| High Point Clinical Trials Center | High Point | North Carolina | 27265 | United States |
| NOT COMPLETED |
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|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| OG002 | 80 mg Ixekizumab Q2W (Once Every Two Weeks) + 1 mg Midazolam | Participants received 80 mg of Ixekizumab on Day 15, Day 29, Day 43, Day 57, and Day 71. Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg of Ixekizumab and 1 mg of Midazolam on the following morning (Day 85; Week 12) during Period 2. |
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Midazolam) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Warfarin) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Dextromethorphan) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
|
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC[0-48h]) of CYP450 Substrate (Caffeine) | All enrolled participants who received at least 1 dose of study drug with evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 1 |
| 28 |
| EG001 | Drug Cocktail + Ixekizumab | Participants received a 160 mg dose of Ixekizumab during an outpatient visit on Day 1 (3 to 7 days after Day 5 of Period 1) and were admitted to the CRU on Day 7 (±2 days) to receive the drug cocktail on the morning of Day 8 (Week 1). Participants received single 80 mg doses of Ixekizumab at outpatient visits on Day 15 (Week 2), Day 29 (Week 4), Day 43 (Week 6), Day 57 (Week 8), and Day 71 (Week 10). Participants were admitted to the CRU on Day 84 (±2 days) and received 80 mg Ixekizumab and the drug cocktail on the following morning (Day 85; Week 12). | 0 | 27 | 0 | 27 | 7 | 27 |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cellulitis of male external genital organ | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
|
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