Trial Outcomes & Findings for A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin (NCT NCT06808646)
NCT ID: NCT06808646
Last Updated: 2026-04-21
Results Overview
To assess the pharmacokinetic parameter Cmax in plasma after a single oral dose of pitavastatin administered without and with intravenous (IV) ceftobiprole
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dose
Results posted on
2026-04-21
Participant Flow
Twelve (12) subjects were enrolled in the study and completed the study as per protocol. The study was conducted in one research center in the Netherlands.
Participant milestones
| Measure |
Entire Population of Subjects
Subjects received treatments in 2 periods: Period 1 (from Day -1 to Day 3): pitavastatin 2 mg single dose; and Period 2 (from Day 4 to Day 8): pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|
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Overall Study
STARTED
|
12
|
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
Baseline characteristics by cohort
| Measure |
Entire Population of Subjects
n=12 Participants
Subjects received treatments in 2 periods: Period 1 (from Day -1 to Day 3): pitavastatin 2 mg single dose; and Period 2 (from Day 4 to Day 8): pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|
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Age, Continuous
|
40.4 years
STANDARD_DEVIATION 15.36 • n=13 Participants
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Sex: Female, Male
Female
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6 Participants
n=13 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
White
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11 Participants
n=13 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=13 Participants
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Height (cm)
|
174.8 cm
STANDARD_DEVIATION 7.50 • n=13 Participants
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Weight (kg)
|
76.67 kg
STANDARD_DEVIATION 12.51 • n=13 Participants
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BMI
|
25.00 kg/m2
STANDARD_DEVIATION 3.06 • n=13 Participants
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PRIMARY outcome
Timeframe: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter Cmax in plasma after a single oral dose of pitavastatin administered without and with intravenous (IV) ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of Pitavastatin
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42.79 ng/mL
Interval 12.8 to 98.7
|
33.54 ng/mL
Interval 8.69 to 98.7
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—
|
PRIMARY outcome
Timeframe: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter AUC0-t after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Area Under the Plasma Concentration-time Curve up to Time (AUC0-t) After Pitavastatin Administration
|
100.29 ng x h/mL
Interval 32.7 to 235.0
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86.63 ng x h/mL
Interval 39.1 to 226.5
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—
|
PRIMARY outcome
Timeframe: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter AUC0-inf after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) After Pitavastatin Administration
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105.42 ng x h/mL
Interval 35.3 to 241.4
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91.59 ng x h/mL
Interval 42.0 to 232.5
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—
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SECONDARY outcome
Timeframe: Sampling on Day 5; pre-dose, 2, 4, 6, 8 h, 16, and 25.5 (Day 6) hours post-dose and corresponding samples on Day -1Population: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
The pharmacokinetic parameter Cmax for CP-I in plasma was assessed with and without administration of IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Cmax of Coproporphyrin I (CP-I)
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0.41 ng/mL
Interval 0.26 to 0.58
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0.42 ng/mL
Interval 0.26 to 0.61
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—
|
SECONDARY outcome
Timeframe: Sampling on Day 5; pre-dose, 2, 4, 6, 8 h, 16, and 25.5 (Day 6) hours post-dose and corresponding samples on Day -1Population: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
The pharmacokinetic parameter AUEC0-25.5h for CP-I was assessed with and without administration of IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Area Under the Plasma Level-time Curve up to Time 25.5 Hours (AUEC0-25.5h) of CP-I in Plasma
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9.08 ng x h/mL
Interval 5.24 to 13.44
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9.27 ng x h/mL
Interval 4.84 to 13.73
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—
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SECONDARY outcome
Timeframe: Sampling on Day 5: pre-dose ,1, 2, 4, 6, 8 h post-dose, on Day 6; pre-dose,1, 2, 4, 6, 8 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter Cmax of IV ceftobiprole without and with oral administration of pitavastatin
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Cmax of Ceftobiprole in Plasma
|
26361 ng/mL
Interval 21200.0 to 33600.0
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27423 ng/mL
Interval 22100.0 to 32600.0
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—
|
SECONDARY outcome
Timeframe: Sampling on Day 5: pre-dose ,1, 2, 4, 6, 8 h post-dose, on Day 6; pre-dose,1, 2, 4, 6, 8 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter AUC0-8h after IV ceftobiprole without and with oral administration of pitavastatin
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Area Under the Plasma Concentration-time Curve up to 8 Hours (AUC0-8h) After IV Ceftobiprole
|
104204 ng x h/mL
Interval 74322.0 to 136270.0
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105623 ng x h/mL
Interval 80376.0 to 140904.0
|
—
|
SECONDARY outcome
Timeframe: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter Cmax of pitavastatin lactone after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
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|---|---|---|---|
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Cmax of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
|
15.91 ng/mL
Interval 8.15 to 20.8
|
14.39 ng/mL
Interval 9.44 to 20.4
|
—
|
SECONDARY outcome
Timeframe: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter AUC0-t of pitavastatin lactone after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
|---|---|---|---|
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AUC0-t of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
|
181.18 ng x h/mL
Interval 94.0 to 304.1
|
157.11 ng x h/mL
Interval 107.0 to 229.4
|
—
|
SECONDARY outcome
Timeframe: Sampling on Day 1 and Day 6; before dosing, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours (h) post-dose. Day 2 and Day 7; 24 and 36 h post-dose. Day 3 and Day 8; 48 h post-dosePopulation: Pharmacokinetic set: The PK set consisted of all subjects who received at least one dose of study drug and provided sufficient bioanalytical assessment results to calculate reliable estimates of the PK parameter
To assess the pharmacokinetic parameter AUC0-inf of pitavastatin lactone after a single oral dose of pitavastatin administered without and with IV ceftobiprole
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
|---|---|---|---|
|
AUC0-inf of of the Pitavastatin Metabolite Pitavastatin Lactone in Plasma After Pitavastatin Administration
|
196.73 ng x h/mL
Interval 101.5 to 361.7
|
171.60 ng x h/mL
Interval 122.1 to 248.0
|
—
|
SECONDARY outcome
Timeframe: Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6Population: safety set: The safety set consisted of all enrolled subjects who have received at least one dose of study drug
A treatment-emergent AE (TEAE) was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
Outcome measures
| Measure |
Period 1; Pitavastatin 2 mg
n=12 Participants
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Period 2; Pitavastatin 2 mg Combined With Ceftobiprole 500 mg
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
Pitavastatin + Ceftobiprole Period 2
n=12 Participants
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
|---|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) After Administration of Ceftobiprole Without and With a Single Oral Dose of Pitavastatin
Any serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) After Administration of Ceftobiprole Without and With a Single Oral Dose of Pitavastatin
Any non-serious TEAE
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) After Administration of Ceftobiprole Without and With a Single Oral Dose of Pitavastatin
Not any TEAE
|
7 Participants
|
5 Participants
|
7 Participants
|
Adverse Events
Pitavastatin Period 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ceftobiprole Period 2
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pitavastatin + Ceftobiprole Period 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pitavastatin Period 1
n=12 participants at risk
Subjects received (from Day -1 to Day 3) pitavastatin 2 mg single dose
|
Ceftobiprole Period 2
n=12 participants at risk
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h)
|
Pitavastatin + Ceftobiprole Period 2
n=12 participants at risk
Subjects received (from Day 4 to Day 8) pitavastatin 2 mg single dose with ceftobiprole 500 mg as a 2-hour IV dose every 8 hours (q8h). On Day 6, a single oral dose of 2 mg pitavastatin was co-administered with ceftobiprole 30 minutes prior to the end of the first IV dose of 500 mg ceftobiprole
|
|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
16.7%
2/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
16.7%
2/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
16.7%
2/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
General disorders
Catheter site irritation
|
16.7%
2/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
25.0%
3/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
0.00%
0/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
8.3%
1/12 • Up to 17 days after first dosing; Pitavastatin Period 1 between first dose on Day1 and before first dose on Day4; ceftobiprole Period 2 between first dose on Day4 and before first dose on Day6; pitavastatin + ceftopibrole Period 2 after first dose on Day6
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
Additional Information
Thomas Kaindl, MD
Basilea Pharmaceutica International Ltd, Allschwil
Phone: +41615671505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place