Trial Outcomes & Findings for A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011) (NCT NCT01558674)
NCT ID: NCT01558674
Last Updated: 2018-09-21
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period
Results posted on
2018-09-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Part 1
STARTED
|
11
|
0
|
|
Part 1
COMPLETED
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
11
|
0
|
|
Part 2
STARTED
|
0
|
0
|
|
Part 2
COMPLETED
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Part 1
Study Terminated by Sponsor
|
10
|
0
|
|
Part 1
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011)
Baseline characteristics by cohort
| Measure |
MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg
n=11 Participants
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.
|
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
—
|
61.4 Years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
—
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
n=10 Participants
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1)
|
11.0 mEq
Interval -18.6 to 40.6
|
109.5 mEq
Interval 82.0 to 137.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15 for Periods 1, 2, and 3; Day 29 for Period 4Population: Part 2 of the study was not conducted. No participants were enrolled.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I)Population: 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.
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.
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
n=10 Participants
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1)
|
1.30 mg/dL
Interval 1.16 to 1.46
|
1.18 mg/dL
Interval 1.1 to 1.27
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5Population: 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
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
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
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)
Treatment Day 1
|
158 nM*hr
Geometric Coefficient of Variation 49.2
|
—
|
—
|
—
|
|
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)
Treatment Day 5
|
485 nM*hr
Geometric Coefficient of Variation 50.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment Day 1 and Treatment Day 5Population: 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
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.
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1)
Treatment Day 1
|
10.2 nM
Geometric Coefficient of Variation 57.9
|
—
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1)
Treatment Day 5
|
26.0 nM
Geometric Coefficient of Variation 50.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment Day 1 and Treatment Day 5Population: 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.
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
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1)
Treatment Day 1
|
NA nM
Geometric Coefficient of Variation NA
Ctrough estimates not available due to lack of data at terminal phase.
|
—
|
—
|
—
|
|
Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1)
Treatment Day 5
|
NA nM
Geometric Coefficient of Variation NA
Ctrough estimates not available due to lack of data at terminal phase.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment Day 1 and Treatment Day 5Population: 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.
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
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1)
Treatment Day 1
|
10.0 hours
Interval 5.0 to 12.0
|
—
|
—
|
—
|
|
Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1)
Treatment Day 5
|
5.0 hours
Interval 5.0 to 12.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Treatment Day 1 and Treatment Day 5Population: 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.
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.
Outcome measures
| Measure |
MK-7145 8 mg (Part 1: Period 1)
n=11 Participants
8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg BID (Part 1: Period 2)
40 mg Furosemide tablet BID for 5 days administered in a fasted state
|
MK-7145 16 mg (Part 1: Period 3)
16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
|
MK-7145 24 mg (Part 2: Period 4)
24 mg of MK-7145 once daily for 28 days
|
|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1)
Treatment Day 5
|
NA hours
t1/2 estimates not available due to lack of data at terminal phase.
|
—
|
—
|
—
|
|
Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1)
Treatment Day 1
|
NA hours
t1/2 estimates not available due to lack of data at terminal phase.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 for Periods 1, 2, and 3; Day 29 for Period 4Population: No participants were enrolled in Part 2 of the study.
Blood samples were collected at 24 hours post last morning dose of each period to determine serum creatinine levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4Population: No participants were enrolled in Part 2 of the study.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 4Population: No participants were enrolled in Part 2 of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4Population: No participants were enrolled in Part 2 of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4Population: No participants were enrolled in Part 2 of the study.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4Population: No participants were enrolled in Part 2 of the study.
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.
Outcome measures
Outcome data not reported
Adverse Events
MK-7145 8 mg (Part 1:Period 1)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Furosemide 40 mg (Part 1:Period 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Post Trial
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-7145 8 mg (Part 1:Period 1)
n=11 participants at risk
Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg (Part 1:Period 2)
n=10 participants at risk
Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state
|
Post Trial
n=11 participants at risk
Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study
|
|---|---|---|---|
|
Infections and infestations
Septic shock
|
0.00%
0/11 • 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.
|
0.00%
0/10 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/11 • 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.
|
0.00%
0/10 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
Other adverse events
| Measure |
MK-7145 8 mg (Part 1:Period 1)
n=11 participants at risk
Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state
|
Furosemide 40 mg (Part 1:Period 2)
n=10 participants at risk
Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state
|
Post Trial
n=11 participants at risk
Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • 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.
|
20.0%
2/10 • Number of events 2 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/11 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
General disorders
Application site inflammation
|
0.00%
0/11 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
General disorders
Catheter site bruise
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
General disorders
Catheter site swelling
|
18.2%
2/11 • Number of events 2 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/11 • 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.
|
0.00%
0/10 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Gout
|
18.2%
2/11 • Number of events 2 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • 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.
|
0.00%
0/10 • 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.
|
9.1%
1/11 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Dizziness postural
|
18.2%
2/11 • Number of events 2 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Headache
|
36.4%
4/11 • Number of events 4 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/11 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Psychiatric disorders
Abnormal dreams
|
9.1%
1/11 • Number of events 1 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Renal and urinary disorders
Renal failure acute
|
27.3%
3/11 • Number of events 3 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
9.1%
1/11 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/11 • 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.
|
|
Vascular disorders
Orthostatic hypotension
|
9.1%
1/11 • Number of events 2 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/11 • 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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER