Trial Outcomes & Findings for A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects (NCT NCT02341482)
NCT ID: NCT02341482
Last Updated: 2020-01-09
Results Overview
AUCtau = area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau = 12 hours. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.
COMPLETED
PHASE1
13 participants
Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21
2020-01-09
Participant Flow
Participant milestones
| Measure |
All Subjects
PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Subjects
PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
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|---|---|
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Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Subjects
n=13 Participants
PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
|
|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21Population: The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.
AUCtau = area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau = 12 hours. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=12 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval, Where Tau = 12 Hours (AUCtau) of PF-04958242
|
4242 picogram*hours per milliliter pg*h/mL
Geometric Coefficient of Variation 30
|
4073 picogram*hours per milliliter pg*h/mL
Geometric Coefficient of Variation 25
|
—
|
PRIMARY outcome
Timeframe: Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21Population: All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.
Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=12 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04958242
|
553.4 pg/mL
Geometric Coefficient of Variation 27
|
541.6 pg/mL
Geometric Coefficient of Variation 20
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21Population: The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.
Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=12 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Time for Cmax (Tmax) of PF-04958242
|
1.50 hours
Interval 1.0 to 1.52
|
1.50 hours
Interval 1.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21Population: All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=12 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-04958242
|
256.5 pg/mL
Geometric Coefficient of Variation 35
|
238.2 pg/mL
Geometric Coefficient of Variation 30
|
—
|
SECONDARY outcome
Timeframe: 0 hour at Day 1, Day 2, Day 3, Day 4, Day 7, Day 10, Day 13, Day 16, and Day 17 (pre-dose)Population: All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=12 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Predose Concentration (Ctrough) of PF-04958242
|
289.3 pg/mL
Geometric Coefficient of Variation 37
|
255.0 pg/mL
Geometric Coefficient of Variation 29
|
—
|
SECONDARY outcome
Timeframe: Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21Population: The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.
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. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=12 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-04958242
|
98.25 milliliters per minute (mL/min)
Geometric Coefficient of Variation 30
|
102.3 milliliters per minute (mL/min)
Geometric Coefficient of Variation 25
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis population included all participants who received at least 1 dose of the study medication.
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, mean corpuscular volume \[MCV\], mean corpuscular hemoglobin \[MCH\], mean corpuscular hemoglobin concentration \[MCHC\], 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, urobilinogen, urine bilirubin and microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (follicle stimulating hormone \[FSH\], urine cotinine, and urine drug screening).
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Abnormal Clinical Laboratory Measurements
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis population included all participants who received at least 1 dose of the study medication.
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate more than (\<)40 or less than (\>)120 beats per minute (bpm); systolic blood pressure (SBP) more than or equal to (\>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mm Hg change from baseline in same posture or DBP \<50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine SBP <90 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine Pulse Rate <40 BPM
|
0 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine Pulse Rate >120 BPM
|
0 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine DBP >=20 mmHg IFB
|
1 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine DBP <50 mmHg
|
0 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine SBP >=30 mmHg IFB
|
2 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine SBP >=30 mmHg DFB
|
0 participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern
Supine DBP >=20 mmHg DFB
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis population included all participants who received at least 1 dose of the study medication.
Electrocardiogram (ECG) parameters included time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) interval, beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, QT interval corrected for heart rate (QTc) interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval \>=300 milliseconds (msec) or \>=25% increase when baseline is \>200 msec and \>=50% increase when baseline is less than or equal to (=\<)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline; and QTcF \>=450 to \<480, 480 to \<500 and \>=500 msec or \>=30 to 60 msec increase and also \>=60 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis population included all participants who received at least 1 dose of the study medication.
The extended neurological examination, performed by a board certified neurologist, included observations for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Significant Change in Neurological Examination From Previous Examination
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis population included all participants who received at least 1 dose of the study medication.
A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Significant Change in Physical Examination From Previous Examination
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last study drug administrationPopulation: The safety analysis population included all participants who received at least 1 dose of 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.
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
n=13 Participants
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 participants
|
7 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis population included all participants who received at least 1 dose of the study medication.
The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Outcome measures
| Measure |
PF-04958242 0.025 mg
n=13 Participants
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg + Itraconazole 200 mg
All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
|
PF-04958242 0.1 mg
All participants who received PF-04958242 0.1 mg BID orally.
|
|---|---|---|---|
|
Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)
|
0 participants
|
—
|
—
|
Adverse Events
PF-04958242 0.1 mg
PF-04958242 0.025 mg
PF-04958242 0.025 mg Combined With Itraconazole 200 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-04958242 0.1 mg
n=13 participants at risk
All participants who received PF-04958242 0.1 mg BID orally.
|
PF-04958242 0.025 mg
n=13 participants at risk
All participants who received PF-04958242 0.025 mg BID orally.
|
PF-04958242 0.025 mg Combined With Itraconazole 200 mg
n=13 participants at risk
All participants who received PF-04958242 0.025 mg combined with itraconazole 200 mg orally.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
15.4%
2/13 • Baseline up to 28 days after last dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
|
General disorders
Drug intolerance
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
General disorders
Fat tissue increased
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
15.4%
2/13 • Baseline up to 28 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Investigations
Urine output decreased
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
15.4%
2/13 • Baseline up to 28 days after last dose of study drug.
|
|
Reproductive system and breast disorders
Penile swelling
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
15.4%
2/13 • Baseline up to 28 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
0.00%
0/13 • Baseline up to 28 days after last dose of study drug.
|
7.7%
1/13 • Baseline up to 28 days after last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place