Trial Outcomes & Findings for Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants (NCT NCT04729101)
NCT ID: NCT04729101
Last Updated: 2023-03-31
Results Overview
Calculated as: Time pH \>4\*100/total actual monitoring period time. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Day 1 and Day 7 of each treatment period
Results posted on
2023-03-31
Participant Flow
A total of 44 participants were enrolled between January 2021 and June 2021 at a single site in the United States.
Overall, 164 participants were screened of which 120 were considered screen failures. Eligible participants were randomized to 1 of the 2 treatment sequences in a 1:1 ratio.
Participant milestones
| Measure |
First Vonoprazan, Then Lansoprazole (Treatment Sequence AB)
Participants received 20 mg vonoprazan (treatment A) as oral tablets once daily (QD) for up to 7 days in Treatment Period 1. Following a 7 day washout period, participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 2.
|
First Lansoprazole, Then Vonoprazan (Treatment Sequence BA)
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1. Following a 7 day washout period, participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 2.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
Received Treatment
|
23
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
First Vonoprazan, Then Lansoprazole (Treatment Sequence AB)
Participants received 20 mg vonoprazan (treatment A) as oral tablets once daily (QD) for up to 7 days in Treatment Period 1. Following a 7 day washout period, participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 2.
|
First Lansoprazole, Then Vonoprazan (Treatment Sequence BA)
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1. Following a 7 day washout period, participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants
Baseline characteristics by cohort
| Measure |
First Vonoprazan, Then Lansoprazole (Treatment Sequence AB)
n=23 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets once daily (QD) for up to 7 days in Treatment Period 1. Following a 7 day washout period, participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 2.
|
First Lansoprazole, Then Vonoprazan (Treatment Sequence BA)
n=21 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1. Following a 7 day washout period, participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 2.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 8.30 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 9.99 • n=7 Participants
|
36.1 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 7 of each treatment periodPopulation: Pharmacodynamic (PD) Population - all participants who received at least one dose of the study drug and had sufficient predose and postdose pH measurements and absence of major protocol violations.
Calculated as: Time pH \>4\*100/total actual monitoring period time. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=41 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration
Day 7
|
87.81 percentage of time
Standard Deviation 15.708
|
42.32 percentage of time
Standard Deviation 25.597
|
|
Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration
Day 1
|
62.40 percentage of time
Standard Deviation 23.351
|
22.61 percentage of time
Standard Deviation 17.309
|
PRIMARY outcome
Timeframe: Day 1 and Day 7 of each treatment periodPopulation: PD Population - all participants who received at least one dose of the study drug and had sufficient predose and postdose pH measurements and absence of major protocol violations.
The average gastric pH was a measure of the immediate effect on gastric pH and the duration of effect on gastric pH. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second. The pH scale ranges from 0 to 14 with values below 7 being more acidic and values above 7 being more basic. Normal gastric pH is between 1.5 and 3.5.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=41 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24)
Day 1
|
4.606 pH
Standard Deviation 1.0852
|
2.848 pH
Standard Deviation 0.79923
|
|
Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24)
Day 7
|
5.903 pH
Standard Deviation 0.84900
|
3.783 pH
Standard Deviation 1.2000
|
PRIMARY outcome
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (Pharmacokinetics \[PK\]) - all participants with an evaluable AUC0-24 profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Calculated using the Linear Trapezoidal with Linear Interpolation Method. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=41 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24)
|
200.6 ng*hr/mL
Standard Deviation 80.954
|
2677 ng*hr/mL
Standard Deviation 1357.1
|
PRIMARY outcome
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (PK) - all participants with an evaluable AUC0-inf profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Calculated as the area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) + (Clast/Kel) where Clast is the last observed/measured concentration and Kel is the apparent first-order terminal elimination rate constant. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=39 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=41 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)
|
229.5 ng*hr/mL
Standard Deviation 98.841
|
2679 ng*hr/mL
Standard Deviation 1361.0
|
PRIMARY outcome
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (PK) - all participants with an evaluable Cmax profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Cmax was taken directly from bioanalytical data. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=41 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
21.79 ng/mL
Standard Deviation 8.3296
|
1110 ng/mL
Standard Deviation 411.88
|
PRIMARY outcome
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (PK) - all participants with an evaluable Tmax profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Taken from the clinical database as the difference in the time of administration and the time of the blood draw which was associated with the Cmax. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=41 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Time to Reach Cmax (Tmax)
|
2.005 hr
Interval 1.0 to 5.01
|
1.499 hr
Interval 0.79 to 4.0
|
PRIMARY outcome
Timeframe: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (PK) - all participants with an evaluable AUCtau profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Calculated using the Linear Trapezoidal with Linear Interpolation Method. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=38 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State (ss)
|
261.4 ng*hr/mL
Standard Deviation 104.18
|
3246 ng*hr/mL
Standard Deviation 2396.4
|
PRIMARY outcome
Timeframe: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (PK) - all participants with an evaluable Cmax,ss profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Cmax,ss was taken directly from bioanalytical data. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=38 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Cmax at Steady State (Cmax,ss)
|
27.39 ng/mL
Standard Deviation 9.9928
|
1164 ng/mL
Standard Deviation 506.53
|
PRIMARY outcome
Timeframe: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdosePopulation: PD Population (PK) - all participants with an evaluable PK profile who received at least one dose of the study drug had sufficient predose and postdose pH measurements and absence of major protocol violations.
Taken from the clinical database as the difference in the time of administration and the time of the blood draw which was associated with the Cmax,ss. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods.
Outcome measures
| Measure |
Vonoprazan
n=40 Participants
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=38 Participants
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Tmax at Steady State (Tmax,ss)
|
2.005 hr
Interval 1.53 to 5.0
|
1.510 hr
Interval 0.75 to 4.02
|
Adverse Events
Vonoprazan
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Lansoprazole
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vonoprazan
n=44 participants at risk
Participants received 20 mg vonoprazan (treatment A) as oral tablets QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
Lansoprazole
n=43 participants at risk
Participants received 30 mg lansoprazole (treatment B) as oral capsules QD for up to 7 days in Treatment Period 1 or Treatment Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Chapped lips
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
7.0%
3/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
9.3%
4/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
General disorders
Fatigue
|
4.5%
2/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
General disorders
Nodule
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
General disorders
Vessel puncture site haematoma
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Oral herpes
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Infections and infestations
Vaginitis gardnerella
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Investigations
Weight decreased
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Burning sensation
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
9.3%
4/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
4.7%
2/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
2/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
2.3%
1/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
2/44 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
0.00%
0/43 • Day 1 to Day 35
The adverse events reported are treatment-emergent adverse events which were defined as any event that occurred after the first dose of study drug or any event at baseline that worsened in either intensity or frequency after the first dose of study drug. The analysis population was the safety population which included all participants who received at least one dose of the study drug.
|
Additional Information
Phathom Medical Information
Phathom Pharmaceuticals, Inc.
Phone: 1-888-775-PHAT (7428)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place