Trial Outcomes & Findings for Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615) (NCT NCT01777763)
NCT ID: NCT01777763
Last Updated: 2017-04-07
Results Overview
Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval. Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
230 participants
Primary outcome timeframe
Predose on Day 1 up to 24 hours postdose on Day 8
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Posaconazole 200 mg
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
210
|
|
Overall Study
COMPLETED
|
16
|
163
|
|
Overall Study
NOT COMPLETED
|
4
|
47
|
Reasons for withdrawal
| Measure |
Posaconazole 200 mg
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
32
|
|
Overall Study
Protocol Violation
|
1
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Treatment Failure
|
1
|
6
|
Baseline Characteristics
Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)
Baseline characteristics by cohort
| Measure |
Posaconazole 200 mg
n=20 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days.
|
Posaconazole 300 mg
n=210 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
51.0 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
51.0 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
131 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose on Day 1 up to 24 hours postdose on Day 8Population: The Cavg PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.
Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval. Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.
Outcome measures
| Measure |
Posaconazole 200 mg
n=18 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=50 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Average Concentration (Cavg) of Posaconazole Tablet
|
981 ng/mL
Standard Deviation 475
|
1580 ng/mL
Standard Deviation 667
|
PRIMARY outcome
Timeframe: Predose on Day 1 up to 24 hours postdose on Day 8Population: The Cmin PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.
Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug.
Outcome measures
| Measure |
Posaconazole 200 mg
n=18 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=50 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Minimum Concentration (Cmin) of Posaconazole Tablet
|
812 ng/mL
Standard Deviation 443
|
1310 ng/mL
Standard Deviation 647
|
PRIMARY outcome
Timeframe: Predose on Day 1 up to 24 hours postdose on Day 8Population: The Cmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.
Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.
Outcome measures
| Measure |
Posaconazole 200 mg
n=18 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=50 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Maximum Concentration (Cmax) of Posaconazole Tablet
Day 8
|
1310 ng/mL
Standard Deviation 617
|
2090 ng/mL
Standard Deviation 798
|
|
Maximum Concentration (Cmax) of Posaconazole Tablet
Day 1
|
652 ng/mL
Standard Deviation 217
|
908 ng/mL
Standard Deviation 354
|
PRIMARY outcome
Timeframe: Predose on Day 1 up to 24 hours postdose on Day 8Population: The Tmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.
Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.
Outcome measures
| Measure |
Posaconazole 200 mg
n=18 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=50 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Time to Maximum Concentration (Tmax) of Posaconazole Tablet
Day 1
|
4 Hours
Interval 1.9 to 4.1
|
4 Hours
Interval 1.8 to 12.0
|
|
Time to Maximum Concentration (Tmax) of Posaconazole Tablet
Day 8
|
4 Hours
Interval 2.0 to 8.1
|
4 Hours
Interval 1.3 to 8.3
|
PRIMARY outcome
Timeframe: Predose on Day 1 up to 24 hours postdose on Day 8Population: The CL/F PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through predose on the Day 8 steady-state visit.
Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.
Outcome measures
| Measure |
Posaconazole 200 mg
n=18 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=50 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F) for Posaconazole Tablet
|
10.9 L/hr
Standard Deviation 5.80
|
9.39 L/hr
Standard Deviation 4.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 65Population: The safety population consisted of all participants who received at least one dose of study drug.
Number of Participants Alive at Day 65
Outcome measures
| Measure |
Posaconazole 200 mg
n=20 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=210 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Number of Participants Surviving at Day 65
|
18 Participants
|
192 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 65Population: The safety population consisted of all participants who received at least one dose of study drug.
AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug.
Outcome measures
| Measure |
Posaconazole 200 mg
n=20 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=210 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
|
20 Participants
|
207 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 65Population: The safety population consisted of all participants who received at least one dose of study drug.
AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug.
Outcome measures
| Measure |
Posaconazole 200 mg
n=20 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=210 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Number of Participants With Treatment-Related AEs
|
10 Participants
|
84 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 28Population: The safety population consisted of all participants who received at least one dose of study drug.
AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs.
Outcome measures
| Measure |
Posaconazole 200 mg
n=20 Participants
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=210 Participants
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to an AE
|
3 Participants
|
38 Participants
|
Adverse Events
Posaconazole 200 mg
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Posaconazole 300 mg
Serious events: 69 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Posaconazole 200 mg
n=20 participants at risk
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=210 participants at risk
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.00%
0/210 • Up to Day 65
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
5.2%
11/210 • Number of events 12 • Up to Day 65
|
|
Blood and lymphatic system disorders
MICROANGIOPATHIC HAEMOLYTIC ANAEMIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Blood and lymphatic system disorders
SPLENIC HAEMORRHAGE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 2 • Up to Day 65
|
|
Blood and lymphatic system disorders
THROMBOTIC THROMBOCYTOPENIC PURPURA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
CARDIOVASCULAR INSUFFICIENCY
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/20 • Up to Day 65
|
1.9%
4/210 • Number of events 4 • Up to Day 65
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
NEUTROPENIC COLITIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
General disorders
ASTHENIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
General disorders
CHEST PAIN
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
General disorders
DRUG INTERACTION
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
General disorders
PYREXIA
|
0.00%
0/20 • Up to Day 65
|
1.4%
3/210 • Number of events 4 • Up to Day 65
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Hepatobiliary disorders
JAUNDICE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE IN INTESTINE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
CHOLECYSTITIS INFECTIVE
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.00%
0/210 • Up to Day 65
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
CYTOMEGALOVIRUS INFECTION
|
0.00%
0/20 • Up to Day 65
|
1.4%
3/210 • Number of events 3 • Up to Day 65
|
|
Infections and infestations
CYTOMEGALOVIRUS VIRAEMIA
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
KLEBSIELLA INFECTION
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION FUNGAL
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
PNEUMONIA
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.00%
0/210 • Up to Day 65
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
SEPSIS
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
2.4%
5/210 • Number of events 6 • Up to Day 65
|
|
Infections and infestations
SEPTIC SHOCK
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.95%
2/210 • Number of events 3 • Up to Day 65
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Infections and infestations
ZYGOMYCOSIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Injury, poisoning and procedural complications
ALLERGIC TRANSFUSION REACTION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Injury, poisoning and procedural complications
TRANSPLANT FAILURE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/20 • Up to Day 65
|
1.4%
3/210 • Number of events 4 • Up to Day 65
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
POLYCYTHAEMIA VERA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-CELL PROLYMPHOCYTIC LEUKAEMIA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Nervous system disorders
DIZZINESS
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.00%
0/210 • Up to Day 65
|
|
Nervous system disorders
INTRACRANIAL PRESSURE INCREASED
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Nervous system disorders
SINUS HEADACHE
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.00%
0/210 • Up to Day 65
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Renal and urinary disorders
RENAL FAILURE
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/20 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/20 • Up to Day 65
|
1.4%
3/210 • Number of events 3 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/20 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Vascular disorders
HYPOTENSION
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
Other adverse events
| Measure |
Posaconazole 200 mg
n=20 participants at risk
Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
|
Posaconazole 300 mg
n=210 participants at risk
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.0%
5/20 • Number of events 13 • Up to Day 65
|
10.5%
22/210 • Number of events 56 • Up to Day 65
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
25.0%
5/20 • Number of events 5 • Up to Day 65
|
16.2%
34/210 • Number of events 40 • Up to Day 65
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
20.0%
4/20 • Number of events 8 • Up to Day 65
|
7.1%
15/210 • Number of events 19 • Up to Day 65
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
35.0%
7/20 • Number of events 13 • Up to Day 65
|
13.3%
28/210 • Number of events 72 • Up to Day 65
|
|
Cardiac disorders
BRADYCARDIA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Cardiac disorders
TACHYCARDIA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
6.2%
13/210 • Number of events 19 • Up to Day 65
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
4.3%
9/210 • Number of events 12 • Up to Day 65
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
30.0%
6/20 • Number of events 6 • Up to Day 65
|
11.0%
23/210 • Number of events 26 • Up to Day 65
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
6.7%
14/210 • Number of events 15 • Up to Day 65
|
|
Gastrointestinal disorders
CONSTIPATION
|
35.0%
7/20 • Number of events 7 • Up to Day 65
|
9.5%
20/210 • Number of events 21 • Up to Day 65
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.0%
8/20 • Number of events 8 • Up to Day 65
|
28.1%
59/210 • Number of events 91 • Up to Day 65
|
|
Gastrointestinal disorders
DYSPEPSIA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
6.2%
13/210 • Number of events 13 • Up to Day 65
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
5.2%
11/210 • Number of events 12 • Up to Day 65
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
3.8%
8/210 • Number of events 11 • Up to Day 65
|
|
Gastrointestinal disorders
NAUSEA
|
20.0%
4/20 • Number of events 6 • Up to Day 65
|
26.2%
55/210 • Number of events 65 • Up to Day 65
|
|
Gastrointestinal disorders
ORAL PAIN
|
15.0%
3/20 • Number of events 3 • Up to Day 65
|
0.95%
2/210 • Number of events 2 • Up to Day 65
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Gastrointestinal disorders
VOMITING
|
40.0%
8/20 • Number of events 8 • Up to Day 65
|
12.9%
27/210 • Number of events 33 • Up to Day 65
|
|
General disorders
ASTHENIA
|
30.0%
6/20 • Number of events 6 • Up to Day 65
|
9.0%
19/210 • Number of events 19 • Up to Day 65
|
|
General disorders
CATHETER SITE ERYTHEMA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
9.5%
20/210 • Number of events 22 • Up to Day 65
|
|
General disorders
CHEST PAIN
|
15.0%
3/20 • Number of events 3 • Up to Day 65
|
3.3%
7/210 • Number of events 7 • Up to Day 65
|
|
General disorders
CHILLS
|
30.0%
6/20 • Number of events 9 • Up to Day 65
|
10.5%
22/210 • Number of events 28 • Up to Day 65
|
|
General disorders
FATIGUE
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
6.7%
14/210 • Number of events 16 • Up to Day 65
|
|
General disorders
MUCOSAL INFLAMMATION
|
30.0%
6/20 • Number of events 9 • Up to Day 65
|
13.8%
29/210 • Number of events 35 • Up to Day 65
|
|
General disorders
OEDEMA PERIPHERAL
|
10.0%
2/20 • Number of events 3 • Up to Day 65
|
15.7%
33/210 • Number of events 39 • Up to Day 65
|
|
General disorders
PYREXIA
|
30.0%
6/20 • Number of events 8 • Up to Day 65
|
27.1%
57/210 • Number of events 84 • Up to Day 65
|
|
Hepatobiliary disorders
CHOLESTASIS
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
0.48%
1/210 • Number of events 1 • Up to Day 65
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
10.0%
2/20 • Number of events 3 • Up to Day 65
|
1.4%
3/210 • Number of events 4 • Up to Day 65
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
7.1%
15/210 • Number of events 22 • Up to Day 65
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/20 • Up to Day 65
|
5.7%
12/210 • Number of events 14 • Up to Day 65
|
|
Investigations
HAEMOGLOBIN DECREASED
|
10.0%
2/20 • Number of events 3 • Up to Day 65
|
1.4%
3/210 • Number of events 3 • Up to Day 65
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.0%
4/20 • Number of events 4 • Up to Day 65
|
8.1%
17/210 • Number of events 18 • Up to Day 65
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
6.2%
13/210 • Number of events 13 • Up to Day 65
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
20.0%
4/20 • Number of events 4 • Up to Day 65
|
21.9%
46/210 • Number of events 56 • Up to Day 65
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
9.5%
20/210 • Number of events 24 • Up to Day 65
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
20.0%
4/20 • Number of events 5 • Up to Day 65
|
8.1%
17/210 • Number of events 19 • Up to Day 65
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/20 • Up to Day 65
|
6.2%
13/210 • Number of events 13 • Up to Day 65
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
20.0%
4/20 • Number of events 4 • Up to Day 65
|
4.8%
10/210 • Number of events 12 • Up to Day 65
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/20 • Up to Day 65
|
6.2%
13/210 • Number of events 14 • Up to Day 65
|
|
Nervous system disorders
HEADACHE
|
20.0%
4/20 • Number of events 4 • Up to Day 65
|
14.3%
30/210 • Number of events 36 • Up to Day 65
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/20 • Up to Day 65
|
6.7%
14/210 • Number of events 14 • Up to Day 65
|
|
Psychiatric disorders
INSOMNIA
|
15.0%
3/20 • Number of events 3 • Up to Day 65
|
7.1%
15/210 • Number of events 16 • Up to Day 65
|
|
Renal and urinary disorders
DYSURIA
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
5.2%
11/210 • Number of events 12 • Up to Day 65
|
|
Renal and urinary disorders
HAEMATURIA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
2.4%
5/210 • Number of events 5 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
35.0%
7/20 • Number of events 7 • Up to Day 65
|
16.7%
35/210 • Number of events 37 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
8.1%
17/210 • Number of events 17 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
30.0%
6/20 • Number of events 7 • Up to Day 65
|
14.3%
30/210 • Number of events 43 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
2.9%
6/210 • Number of events 6 • Up to Day 65
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/20 • Up to Day 65
|
5.7%
12/210 • Number of events 13 • Up to Day 65
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
5.7%
12/210 • Number of events 14 • Up to Day 65
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
10.0%
2/20 • Number of events 2 • Up to Day 65
|
9.0%
19/210 • Number of events 22 • Up to Day 65
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.0%
1/20 • Number of events 1 • Up to Day 65
|
7.6%
16/210 • Number of events 17 • Up to Day 65
|
|
Skin and subcutaneous tissue disorders
RASH
|
25.0%
5/20 • Number of events 5 • Up to Day 65
|
16.2%
34/210 • Number of events 39 • Up to Day 65
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
10.0%
2/20 • Number of events 3 • Up to Day 65
|
1.4%
3/210 • Number of events 3 • Up to Day 65
|
|
Vascular disorders
HYPERTENSION
|
15.0%
3/20 • Number of events 3 • Up to Day 65
|
11.0%
23/210 • Number of events 24 • Up to Day 65
|
|
Vascular disorders
HYPOTENSION
|
15.0%
3/20 • Number of events 4 • Up to Day 65
|
5.7%
12/210 • Number of events 15 • Up to Day 65
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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.
- Publication restrictions are in place
Restriction type: OTHER