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| ID | Type | Description | Link |
|---|---|---|---|
| I4K-MC-GPEA | Other Identifier | Eli Lilly and Company |
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This study compares LY2452473 taken orally as a 5 milligram (mg) capsule at the same time as a 5 mg tadalafil tablet with three different combination tablets (LY900010) of 5 mg LY2452473 and 5 mg tadalafil taken orally. The study will evaluate the amount of LY2452473 and tadalafil circulating in the blood for each treatment. Side effects will be documented. This study is approximately 34 days not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg LY2452473 + 5 mg Tadalafil | Active Comparator | 5-mg LY2452473 oral capsule and 5-mg tadalafil oral tablet, administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. |
|
| LY900010 (particle size #1) | Experimental | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a smaller particle size (d90 = 10 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
|
| LY900010 (particle size #2) | Experimental | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with an intermediate particle size (d90 = 25 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
|
| LY900010 (particle size #3) | Experimental | Single combination tablet containing 5 mg tadalafil and 5 mg LY2452473 with a larger particle size (d90 = 40 microns), administered orally, once only. There will be a washout period of at least 7 days between doses of study drug. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2452473 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2452473 | Predose up to 96 hours postdose for each of the 4 treatment periods | |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2452473 | Predose up to 96 hours postdose for each of the 4 treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUC(0-∞) of Tadalafil | Predose up to 96 hours postdose for each of the 4 treatment periods | |
| Pharmacokinetics: Cmax of Tadalafil | Predose up to 96 hours postdose for each of the 4 treatment periods |
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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 | 53704 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | First intervention: A 5-milligram (mg) LY2452473 capsule and 5-mg tadalafil tablet administered orally, once. Second intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) administered orally, once. Third intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once. Fourth intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once. There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| FG001 | Sequence 2 | First intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once. Second intervention: A 5-mg LY2452473 capsule and 5-mg tadalafil tablet administered orally, once. Third intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once. Fourth intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) administered orally, once. There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| FG002 | Sequence 3 | First intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once. Second intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once. Third intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 =40 microns, and 5 mg tadalafil) administered orally, once. Fourth intervention: A 5-mg LY2452473 capsule and 5-mg tadalafil tablet administered orally, once. There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| FG003 | Sequence 4 | First intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) administered orally, once. Second intervention: A single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) administered orally, once. Third intervention: A 5-mg LY2452473 capsule and 5-mg tadalafil tablet administered orally, once. Fourth intervention: A single combination tablet LY900010 (5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) administered orally, once. There was a washout period of at least 7 days between each intervention. d90 is a measurement of the distribution of particle widths such that 90% of the particles have a diameter less than the specified value. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| First Washout Period of 1 Week |
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| Second Intervention |
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| Second Washout Period of 1 Week |
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| Third Intervention |
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| Third Washout Period of 1 Week |
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| Fourth Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All randomized participants |
| 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: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2452473 | Entire study population: All randomized participants. | Posted | Mean | Standard Deviation | nanograms*hours per milliliter (ng*h/mL) | Predose up to 96 hours postdose for each of the 4 treatment periods |
|
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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 | 5 mg LY2452473 and 5 mg Tadalafil | Participants who were administered a 5-mg LY2452473 capsule and 5-mg tadalafil tablet during any study period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scleral hyperaemia | Eye 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 |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C582633 | LY2452473 |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Tadalafil |
| Drug |
Administered orally |
|
|
| LY900010 | Drug | Administered orally |
|
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Race, Customized | Count of Participants | Participants |
|
| OG002 | LY900010 (Particle Size #2) | Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) during any study period. |
| OG003 | LY900010 (Particle Size #3) | Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) during any study period. |
|
|
|
| Primary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2452473 | Entire study population: All randomized participants. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Predose up to 96 hours postdose for each of the 4 treatment periods |
|
|
|
|
| Secondary | Pharmacokinetics: AUC(0-∞) of Tadalafil | Entire study population: All randomized participants. | Posted | Mean | Standard Deviation | nanograms*hours per milliliter (ng*h/mL) | Predose up to 96 hours postdose for each of the 4 treatment periods |
|
|
|
|
| Secondary | Pharmacokinetics: Cmax of Tadalafil | Entire study population: All randomized participants. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Predose up to 96 hours postdose for each of the 4 treatment periods |
|
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| EG001 | LY900010 (Particle Size #1) | Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a smaller particle size #1, d90 = 10 microns, and 5 mg tadalafil) during any study period. | 0 | 24 | 7 | 24 |
| EG002 | LY900010 (Particle Size #2) | Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with an intermediate particle size #2, d90 = 25 microns, and 5 mg tadalafil) during any study period. | 0 | 24 | 5 | 24 |
| EG003 | LY900010 (Particle Size #3) | Participants who were administered a single combination tablet LY900010 (containing 5 mg LY2452473 with a larger particle size #3, d90 = 40 microns, and 5 mg tadalafil) during any study period. | 0 | 24 | 3 | 24 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sensation of pressure | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Penis disorder | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Geometric LS Mean Ratio |
| 0.78 |
| 2-Sided |
| 90 |
| 0.71 |
| 0.85 |
Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. |
| Non-Inferiority or Equivalence |
Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant. |
| Geometric LS Mean Ratio | 0.93 | 2-Sided | 90 | 0.85 | 1.01 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Non-Inferiority or Equivalence | Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant. |
| Geometric LS Mean Ratio | 0.77 | 2-Sided | 90 | 0.70 | 0.84 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Non-Inferiority or Equivalence | Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant. |
| Geometric LS Mean Ratio | 0.91 | 2-Sided | 90 | 0.84 | 1.00 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Non-Inferiority or Equivalence | Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant. |
| Geometric LS Mean Ratio | 0.99 | 2-Sided | 90 | 0.91 | 1.08 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Non-Inferiority or Equivalence | Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant. |
| Geometric LS Mean Ratio |
| 0.94 |
| 2-Sided |
| 90 |
| 0.89 |
| 1.00 |
| Superiority or Other |
| Geometric LS Mean Ratio | 0.96 | 2-Sided | 90 | 0.90 | 1.02 | Superiority or Other |
| Geometric LS Mean Ratio | 0.96 | 2-Sided | 90 | 0.90 | 1.02 | Superiority or Other |
| Geometric LS Mean Ratio | 0.97 | 2-Sided | 90 | 0.91 | 1.03 | Superiority or Other |
| Geometric LS Mean Ratio | 1.01 | 2-Sided | 90 | 0.95 | 1.08 | Superiority or Other |
| Geometric LS Mean Ratio |
| 0.71 |
| 2-Sided |
| 90 |
| 0.66 |
| 0.76 |
Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. |
| Superiority or Other |
| Geometric LS Mean Ratio | 0.98 | 2-Sided | 90 | 0.92 | 1.05 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Superiority or Other |
| Geometric LS Mean Ratio | 0.69 | 2-Sided | 90 | 0.65 | 0.74 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Superiority or Other |
| Geometric LS Mean Ratio | 0.96 | 2-Sided | 90 | 0.90 | 1.02 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Superiority or Other |
| Geometric LS Mean Ratio | 0.98 | 2-Sided | 90 | 0.91 | 1.04 | Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor. | Superiority or Other |