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Lack of efficacy
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Part I is a 3-period, active comparator-controlled, fixed sequence study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-7145 compared to furosemide in participants with moderate-to-severe renal insufficiency (RI) without heart failure (HF). Primary hypothesis for Part I is that at least one well-tolerated dose of MK-7145 will produce a greater 24hr urinary excretion of sodium (UNa) on the 1st day of MK-7145 dosing than 80 mg furosemide (on the 1st day of furosemide dosing) in participants with moderate-to-severe RI. If MK-7145 is safe at natriuretic doses in RI in Part I of this study, MK-7145 will be investigated in participants with heart failure (HF) and RI (Part II).
Part II is 4 period, fixed sequence, active comparator controlled (in Period 1), titration (in Periods 2, 3 and 4) study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a titration regimen of MK-7145 compared to an optimized stable maintenance regimen of furosemide or torsemide in participants with New York Heart Association (NYHA) Class II and III heart failure and moderate or severe renal insufficiency. The primary hypothesis for Part II is that at least one dose of MK-7145, titrated according to a fixed dose titration regimen, will be associated with a reduction in N-terminal pro-brain natriuretic peptide (NT-proBNP) compared to furosemide or torsemide (at 24 hours post morning dose on the last dosing day of each period) in participants with NYHA class II/III HF with moderate or severe RI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-7145 8 mg (Part I:Period 1) | Experimental | Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state |
|
| Furosemide 40 mg (Part I:Period 2) | Active Comparator | Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state |
|
| MK-7145 16 mg (Part I:Period 3) | Experimental | Single daily dose of 16 mg MK-7145 for 5 days, capsules, orally administered in a fasted state |
|
| Furosemide/Torsemide Run-in (Part II:Period1) | Active Comparator | Run-in of stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks |
|
| MK-7145 10 mg (Part II:Period 2) | Experimental | Single daily dose of 10 mg MK-7145 for 14 days, capsules, orally administered in a fasted state |
|
| MK-7145 16 mg (Part II:Period 3) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7145 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1) | Urine was collected at Treatment Day -1 and Treatment Day 1 at 0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hour. The 24-hour cumulative natriuresis will be estimated by the amount of sodium excreted into urine over 24 hour period postdose, where amount of sodium is the product of sodium concentration and the volume of urine. The change from baseline in UNa from baseline (Treatment Day -1) and 24 hours post-dose on Treatment Day 1 were calculated. | Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period |
| N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Values at 24 Hours Post Last Morning Dose of Each Period (Part 2) | B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. Levels of BNP levels were assessed 24 hours post last morning dose of study drug for each treatment period. | Day 15 for Periods 1, 2, and 3; Day 29 for Period 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1) | Blood was collected predose on Treatment Day 1 and at 24 hours post morning dose on Treatment Day 5 to determine serum creatinine levels. Creatinine levels were log transformed and then fold change from baseline was calculated. | Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I) |
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Inclusion Criteria:
Parts I and II
Part I Only
- Estimated creatinine clearance of ≤45 mL/min.
Part II Only
Exclusion Criteria:
Parts I and II
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Study was terminated early due to lack of efficacy of MK-7145. Only 11 participants were enrolled and dosed in Part 1. Period 3 of Part 1 was not conducted. No participants were enrolled in the planned Part 2 of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg | Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out. |
| FG001 | Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg | Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
|
| |||||||||||||||||||||
| Part 2 |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg | Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out. |
| BG001 | Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg |
| 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 | Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1) | Urine was collected at Treatment Day -1 and Treatment Day 1 at 0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hour. The 24-hour cumulative natriuresis will be estimated by the amount of sodium excreted into urine over 24 hour period postdose, where amount of sodium is the product of sodium concentration and the volume of urine. The change from baseline in UNa from baseline (Treatment Day -1) and 24 hours post-dose on Treatment Day 1 were calculated. | All participants who received at least 1 dose of study drug and who complied with the protocol sufficiently. One participant did not participate for several time intervals on Period 2: Day 8 due to being unwell, and data from this day of this participant were excluded from the analysis. Part 1: Period 3 was not conducted. | Posted | Least Squares Mean | 95% Confidence Interval | mEq | Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period |
|
Up to 33 days for each treatment period (Period 1includes a break of up to 25 days between Periods 1 and 2; Period 2 includes 14 days post last dose in Period 2). Post-trial period includes time from 14 days post last dose to last reported AE (~ 90 days)
Population includes all participants who received at least one dose of the study drug. Adverse events (AEs) for the treatment period are reported by study drug taken during the active treatment periods. AEs for the post trial period are reported as one group. Part 1: Period 3 and Part 2: All periods were not conducted.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-7145 8 mg (Part 1:Period 1) | Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
Study terminated early due to lack of efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C000619418 | MK-7145 |
| D005665 | Furosemide |
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Experimental |
Single daily dose of 16 mg MK-7145 for 14 days, capsules, orally administered in a fasted state |
|
| MK-7145 24 mg (Part II:Period 4) | Experimental | Single dose of 24 mg MK-7145 for 28 days, capsules, orally administered in a fasted state |
|
| Furosemide | Drug |
|
|
| Torsemide | Drug |
|
| Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Day 4 (Treatment Day 1) through Day 8 (Treatment Day 5) at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96, 101, 104, 106, 108, 110 and 120 hours (relative to Day 4 dosing). The AUC0-24 was calculated for Days 1 and 5 | up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5 |
| Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Cmax was calculated for Treatment Days 1 and 5. | Treatment Day 1 and Treatment Day 5 |
| Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Ctrough for was calculated for Treatment Days 1 and 5 | Treatment Day 1 and Treatment Day 5 |
| Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The time to Cmax (Tmax) calculated for Treatment Days 1 and 5 | Treatment Day 1 and Treatment Day 5 |
| Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The t1/2 was calculated. | Treatment Day 1 and Treatment Day 5 |
| Serum Creatinine Measured at 24 Hours Post Last Morning Dose of Each Period (Part 2) | Blood samples were collected at 24 hours post last morning dose of each period to determine serum creatinine levels | Day 15 for Periods 1, 2, and 3; Day 29 for Period 4 |
| Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3-4 to determine the AUC0-24hr | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
| Maximum Plasma Concentration (Cmax) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 2-4 to determine the Cmax. | up to 24 hours post morning dose on up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
| Trough Plasma Concentration (Ctrough) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Ctrough. | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
| Time to Cmax (Tmax) of MK-7145(Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Tmax. | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
| Apparent Terminal Half-life (t1/2) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the t1/2. | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
| NOT COMPLETED |
|
Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state |
| OG001 | Furosemide 40 mg BID (Part 1: Period 2) | 40 mg Furosemide tablet BID for 5 days administered in a fasted state |
| OG002 | MK-7145 16 mg (Part 1: Period 3) | 16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state |
|
|
|
| Primary | N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Values at 24 Hours Post Last Morning Dose of Each Period (Part 2) | B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. Levels of BNP levels were assessed 24 hours post last morning dose of study drug for each treatment period. | Part 2 of the study was not conducted. No participants were enrolled. | Posted | Day 15 for Periods 1, 2, and 3; Day 29 for Period 4 |
|
|
| Secondary | Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1) | Blood was collected predose on Treatment Day 1 and at 24 hours post morning dose on Treatment Day 5 to determine serum creatinine levels. Creatinine levels were log transformed and then fold change from baseline was calculated. | All participants who received at least 1 dose of study drug , who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted. | Posted | Geometric Mean | 95% Confidence Interval | mg/dL | Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I) |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Day 4 (Treatment Day 1) through Day 8 (Treatment Day 5) at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96, 101, 104, 106, 108, 110 and 120 hours (relative to Day 4 dosing). The AUC0-24 was calculated for Days 1 and 5 | All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted | Posted | Geometric Mean | Geometric Coefficient of Variation | nM*hr | up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Cmax was calculated for Treatment Days 1 and 5. | All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Treatment Day 1 and Treatment Day 5 |
|
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Ctrough for was calculated for Treatment Days 1 and 5 | All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Ctrough for MK-7145 8 mg arm could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Treatment Day 1 and Treatment Day 5 |
|
|
|
| Secondary | Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The time to Cmax (Tmax) calculated for Treatment Days 1 and 5 | All participants who received at least 1 dose of MK-7145 who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted. | Posted | Median | Full Range | hours | Treatment Day 1 and Treatment Day 5 |
|
|
|
| Secondary | Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1) | Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The t1/2 was calculated. | All participants who received at least 1 dose of MK-7145 and who complied with the protocol sufficiently and had data available for endpoint. t1/2 could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted. | Posted | Median | 95% Confidence Interval | hours | Treatment Day 1 and Treatment Day 5 |
|
|
|
| Secondary | Serum Creatinine Measured at 24 Hours Post Last Morning Dose of Each Period (Part 2) | Blood samples were collected at 24 hours post last morning dose of each period to determine serum creatinine levels | No participants were enrolled in Part 2 of the study. | Posted | Day 15 for Periods 1, 2, and 3; Day 29 for Period 4 |
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3-4 to determine the AUC0-24hr | No participants were enrolled in Part 2 of the study. | Posted | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 2-4 to determine the Cmax. | No participants were enrolled in Part 2 of the study. | Posted | up to 24 hours post morning dose on up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
|
|
| Secondary | Trough Plasma Concentration (Ctrough) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Ctrough. | No participants were enrolled in Part 2 of the study. | Posted | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
|
|
| Secondary | Time to Cmax (Tmax) of MK-7145(Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Tmax. | No participants were enrolled in Part 2 of the study. | Posted | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
|
|
| Secondary | Apparent Terminal Half-life (t1/2) of MK-7145 (Part 2) | Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the t1/2. | No participants were enrolled in Part 2 of the study. | Posted | up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 |
|
|
| 0 |
| 11 |
| 10 |
| 11 |
| EG001 | Furosemide 40 mg (Part 1:Period 2) | Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state | 0 | 10 | 5 | 10 |
| EG002 | Post Trial | Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study | 1 | 11 | 3 | 11 |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Application site inflammation | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 17.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA version 17.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |