Trial Outcomes & Findings for Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059) (NCT NCT01380184)
NCT ID: NCT01380184
Last Updated: 2019-04-19
Results Overview
Tlag is the time taken for ridaforolimus to appear in systemic circulation following oral administration. The median and full range (minimum, maximum) for Tlag after a single dose of ridafolorlimus are presented.
COMPLETED
PHASE1
15 participants
Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 is 19 days
2019-04-19
Participant Flow
Fifteen (15) Chinese participants with treatment-refractory advanced or relapsed cancers were enrolled in this study.
Participant milestones
| Measure |
Ridaforolimus 40 mg
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Part 1 (19 Days)
STARTED
|
15
|
|
Part 1 (19 Days)
COMPLETED
|
14
|
|
Part 1 (19 Days)
NOT COMPLETED
|
1
|
|
Washout Period (≥2 Days)
STARTED
|
14
|
|
Washout Period (≥2 Days)
COMPLETED
|
14
|
|
Washout Period (≥2 Days)
NOT COMPLETED
|
0
|
|
Part 2
STARTED
|
14
|
|
Part 2
COMPLETED
|
0
|
|
Part 2
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Ridaforolimus 40 mg
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Part 1 (19 Days)
Adverse Event
|
1
|
|
Part 2
Adverse Event
|
5
|
|
Part 2
Disease Progression
|
8
|
|
Part 2
Lost to Follow-up
|
1
|
Baseline Characteristics
Pharmacokinetics of Ridaforolimus (MK-8669) in Chinese Participants (MK-8669-059)
Baseline characteristics by cohort
| Measure |
Ridaforolimus 40 mg
n=15 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
Tlag is the time taken for ridaforolimus to appear in systemic circulation following oral administration. The median and full range (minimum, maximum) for Tlag after a single dose of ridafolorlimus are presented.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=15 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Lag Time (Tlag) of Ridaforolimus: Day 1
|
2.00 Hours
Interval 0.97 to 8.07
|
PRIMARY outcome
Timeframe: Cycle 1: Predose on Day 1 and at various time points through to 24 hours postdose on Day 19; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
AUC0-∞ represents the total exposure to ridaforolimus and its average blood concentration multiplied by the total amount of time (extrapolated to infinity) that ridaforolimus was in the body. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric mean and back-transformed 95% confidence interval are presented for AUC0-∞.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=13 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Area Under the Curve From 0 to Infinity (AUC0-∞) of Ridaforolimus: Cycle 1 (Cycle 1 is 19 Days)
|
3648 ng*hr/mL
Interval 3044.0 to 4372.0
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
AUC0-24hr represents the total exposure to ridaforolimus and its average blood concentration multiplied by the total amount of time (extrapolated to 24 hours) that ridaforolimus was in the body. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for AUC0-24hr.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=13 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Ridaforolimus: Day 1, Day 19
Day 1
|
1846 ng*hr/mL
Interval 1361.0 to 2503.0
|
|
Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Ridaforolimus: Day 1, Day 19
Day 19
|
2014 ng*hr/mL
Interval 1485.0 to 2731.0
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
Cmax is the peak blood plasma concentration following a dose of ridaforolimus. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for Cmax.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=13 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Maximum Concentration (Cmax) of Ridaforolimus: Day 1, Day 19
Day 1
|
210 ng/mL
Interval 150.0 to 295.0
|
|
Maximum Concentration (Cmax) of Ridaforolimus: Day 1, Day 19
Day 19
|
167 ng/mL
Interval 119.0 to 234.0
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
C24hr is the concentration of ridaforolimus in the blood 24 hours after a dose of ridaforolimus. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for C24hr.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=15 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Concentration at 24 Hours (C24hr) of Ridaforolimus: Day 1, Day 19
Day 1
|
34.8 ng/mL
Interval 26.0 to 46.8
|
|
Concentration at 24 Hours (C24hr) of Ridaforolimus: Day 1, Day 19
Day 19
|
49.7 ng/mL
Interval 36.4 to 67.7
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
Tmax is the time at which the Cmax of ridaforolimus is reached. The medians and ranges (minimum, maximum) for Tmax after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=13 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Time to Maximum Concentration (Tmax) of Ridaforolimus: Day 1, Day 19
Day 1
|
4.03 Hours
Interval 2.0 to 7.97
|
|
Time to Maximum Concentration (Tmax) of Ridaforolimus: Day 1, Day 19
Day 19
|
4.00 Hours
Interval 0.0 to 6.0
|
PRIMARY outcome
Timeframe: Cycle 1: Predose on Day 1 and at various time points through to 24 hours postdose on Day 19; Cycle 1 is 19 daysPopulation: The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.
t½ is the time that it takes for the concentration of ridaforolimus in the body to decrease by half. The (harmonic) means and 95% confidence intervals for t1/2 after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=15 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Apparent Terminal Half-life (t1/2) of Ridaforolimus: Cycle 1 (Cycle 1 is 19 Days)
|
52.9 Hours
Interval 40.2 to 65.6
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after last dose (Up to 26 weeks)Population: The Safety Population consisted of all participants who received at least one dose of study treatment.
A laboratory AE (LAE) is defined as any unfavorable \& unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE (CAE) is defined similarly but also includes changes in structure or function of the body. Serious AEs (SAEs) are those that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement.
Outcome measures
| Measure |
Ridaforolimus 40 mg
n=15 Participants
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Clinical & Laboratory AEs
|
15 Participants
|
|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Drug-related AEs
|
15 Participants
|
|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)
Serious AEs (SAEs)
|
4 Participants
|
Adverse Events
Ridaforolimus 40 mg
Serious adverse events
| Measure |
Ridaforolimus 40 mg
n=15 participants at risk
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
General disorders
Disease progression
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
13.3%
2/15 • Number of events 2 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Ridaforolimus 40 mg
n=15 participants at risk
In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
5/15 • Number of events 5 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 3 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Periodontal disease
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
80.0%
12/15 • Number of events 15 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 4 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
40.0%
6/15 • Number of events 8 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Paronychia
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
3/15 • Number of events 3 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Number of events 2 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
26.7%
4/15 • Number of events 4 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood cholesterol increased
|
33.3%
5/15 • Number of events 6 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
40.0%
6/15 • Number of events 6 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Platelet count decreased
|
33.3%
5/15 • Number of events 9 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
53.3%
8/15 • Number of events 13 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
46.7%
7/15 • Number of events 7 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
5/15 • Number of events 5 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Number of events 2 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
73.3%
11/15 • Number of events 11 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Number of events 2 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
20.0%
3/15 • Number of events 4 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • From first dose up to 30 days after last dose (Up to 26 weeks)
The Safety Population consisted of all participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
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