Trial Outcomes & Findings for A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers (NCT NCT02319148)
NCT ID: NCT02319148
Last Updated: 2016-09-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration
Results posted on
2016-09-16
Participant Flow
Participant milestones
| Measure |
PF-00489791 20 mg
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|
|
First Intervention Period
STARTED
|
22
|
0
|
0
|
0
|
|
First Intervention Period
COMPLETED
|
22
|
0
|
0
|
0
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 4 Days
STARTED
|
22
|
0
|
0
|
0
|
|
Washout Period 4 Days
COMPLETED
|
22
|
0
|
0
|
0
|
|
Washout Period 4 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention Period
STARTED
|
0
|
7
|
7
|
8
|
|
Second Intervention Period
COMPLETED
|
0
|
6
|
6
|
6
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
PF-00489791 20 mg
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|
|
Second Intervention Period
Adverse event (AE) related to study drug
|
0
|
0
|
1
|
1
|
|
Second Intervention Period
No longer willing to participate
|
0
|
1
|
0
|
0
|
|
Second Intervention Period
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
PF-00489791 20 mg + Itraconazole 200 mg
n=7 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=7 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=8 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
35.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-00489791
|
1140 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
1238 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
1198 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
1186 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791
|
17880 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
|
18140 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
16840 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
19560 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791
|
17580 ng.hr/mL
Geometric Coefficient of Variation 36
|
17980 ng.hr/mL
Geometric Coefficient of Variation 24
|
16760 ng.hr/mL
Geometric Coefficient of Variation 20
|
19400 ng.hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791
|
4.00 hour
Interval 2.0 to 4.08
|
3.50 hour
Interval 2.0 to 4.0
|
4.00 hour
Interval 1.0 to 4.0
|
4.00 hour
Interval 2.0 to 4.07
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-00489791
|
18.06 liter
Geometric Coefficient of Variation 34
|
21.65 liter
Geometric Coefficient of Variation 18
|
19.98 liter
Geometric Coefficient of Variation 31
|
19.23 liter
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-00489791
|
18.64 milliliter per minute (mL/min)
Geometric Coefficient of Variation 36
|
18.37 milliliter per minute (mL/min)
Geometric Coefficient of Variation 24
|
19.81 milliliter per minute (mL/min)
Geometric Coefficient of Variation 20
|
17.02 milliliter per minute (mL/min)
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administrationPopulation: The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
t1/2 is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of PF-00489791
|
11.39 hour
Standard Deviation 2.15
|
13.85 hour
Standard Deviation 2.79
|
11.75 hour
Standard Deviation 1.69
|
13.29 hour
Standard Deviation 2.56
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last study drug administrationPopulation: The safety analysis population included all participants who received the study medication.
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (coagulation panel, circulating immune complex, and complement activation).
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
|
3 participants
|
0 participants
|
0 participants
|
2 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 9Population: The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) of \>=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mm Hg.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=7 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=7 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=8 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine SBP <90 mm Hg (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing SBP <90 mm Hg (n=22,7,6,8)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine DBP <50 mm Hg (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing DBP <50 mm Hg (n=22,7,6,8)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine Pulse Rate <40 or >120 bpm (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing Pulse Rate <40 or >120 bpm (n=22,7,6,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine SBP >=30 mm Hg IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing SBP >=30 mm Hg IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine DBP >=20 mm Hg IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing DBP >=20 mm Hg IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine SBP >=30 mm Hg DFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing SBP >=30 mm Hg DFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Supine DBP >=20 mm Hg DFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Standing DBP >=20 mm Hg DFB (n=22,6,6,7)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2Population: The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.
ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (\>=)300 milliseconds (msec) or \>=25% increase when baseline is greater than (\>)200 msec and \>=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline (IFB); and QTcF \>=450 msec or \>=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=7 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=7 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=8 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=300 msec (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QRS Complex >=140 msec (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval 450-<480 msec (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval 480-<500 msec (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval >=500 msec (n=22,7,7,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
PR Interval >=25/50% IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QRS Interval >=50% IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval 30-<60 msec IFB (n=22,6,6,7)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
QTcF Interval >=60 msec IFB (n=22,6,6,7)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 15 (final study evaluation)Population: The safety analysis population included all participants who received the study medication.
Participants were to abstain from all concomitant treatments, except for the treatment of AEs. Treatments taken after the first dose of study treatment were documented as concomitant treatments.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Used at Least 1 Concomitant Medication
Drug Treatments
|
10 participants
|
2 participants
|
4 participants
|
2 participants
|
—
|
—
|
—
|
|
Number of Participants Who Used at Least 1 Concomitant Medication
Non-Drug Treatments
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last study drug administrationPopulation: The safety analysis population included all participants who received the study medication.
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
PF-00489791 20 mg
n=22 Participants
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=7 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=7 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=8 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 Participants
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 Participants
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 Participants
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
AEs
|
18 participants
|
6 participants
|
4 participants
|
3 participants
|
6 participants
|
4 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
PF-00489791 20 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Itraconazole 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Diltiazem 240 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Verapamil 240 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-00489791 20 mg + Itraconazole 200 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-00489791 20 mg + Diltiazem 240 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-00489791 20 mg + Verapamil 240 mg
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 |
PF-00489791 20 mg
n=22 participants at risk
All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
|
Itraconazole 200 mg
n=7 participants at risk
All participants who received itraconazole 200 mg orally once daily for 7 days.
|
Diltiazem 240 mg
n=7 participants at risk
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
|
Verapamil 240 mg
n=8 participants at risk
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
|
PF-00489791 20 mg + Itraconazole 200 mg
n=6 participants at risk
All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
|
PF-00489791 20 mg + Diltiazem 240 mg
n=6 participants at risk
All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
|
PF-00489791 20 mg + Verapamil 240 mg
n=6 participants at risk
All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.6%
2/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.6%
2/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
2/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
22.7%
5/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
9.1%
2/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.4%
8/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
57.1%
4/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
18.2%
4/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
9.1%
2/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
63.6%
14/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
57.1%
4/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
2/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
6/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Irritability
|
4.5%
1/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Polyuria
|
4.5%
1/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hot flush
|
13.6%
3/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
83.3%
5/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
3/22 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
12.5%
1/8 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline up to 28 days after last study drug administration
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER