Trial Outcomes & Findings for A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy (NCT NCT04977336)
NCT ID: NCT04977336
Last Updated: 2025-06-25
Results Overview
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
274 participants
Primary outcome timeframe
0 to 48 hours After First Dose of Study Drug
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
|
HB/APAP
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
|
VX-548: Low Dose
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg every 12 hours (q12h) for 2 days.
|
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
33
|
62
|
60
|
|
Overall Study
COMPLETED
|
58
|
60
|
32
|
61
|
58
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to VX-548 and Hydrocodone bitartrate/acetaminophen (HB/APAP) for 2 days.
|
HB/APAP
Participants received HB 5 milligrams (mg)/ APAP 325 mg every 6 hours (q6h) for 2 days.
|
VX-548: Low Dose
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg every 12 hours (q12h) for 2 days.
|
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal of Consent (not due to AE)
|
1
|
0
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy
Baseline characteristics by cohort
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
86 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
188 Participants
n=10 Participants
|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
47.6 years
STANDARD_DEVIATION 13.7 • n=21 Participants
|
48.4 years
STANDARD_DEVIATION 13.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
234 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
193 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Pain Intensity at Baseline (at 0 hours) as Recorded on Numeric Pain Rating Scale (NPRS)
|
6.9 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.8 • n=4 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 1.7 • n=21 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 1.8 • n=10 Participants
|
PRIMARY outcome
Timeframe: 0 to 48 hours After First Dose of Study DrugPopulation: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID48 was calculated from 0 to 48 hours and the score range was -480 (worst score) to 480 (best score).
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Time-Weighted Sum of Pain Intensity Difference (SPID) as Recorded on a Numeric Pain Rating Scale (NPRS) 0 to 48 Hours (SPID48) After the First Dose of Study Drug
|
100.98 units on a scale
Standard Error 11.60
|
115.64 units on a scale
Standard Error 11.49
|
112.92 units on a scale
Standard Error 15.52
|
86.87 units on a scale
Standard Error 11.33
|
137.77 units on a scale
Standard Error 11.50
|
SECONDARY outcome
Timeframe: 0 to 24 hours After First Dose of Study DrugPopulation: FAS.
SPID was calculated as the sum of the product of time (in hours) elapsed since previous measurements and pain intensity difference. Pain intensity difference was calculated by subtracting the pain intensity score at given post-dose time points from the baseline pain intensity scores (using pain rating score range: 0= no pain to 10= worst possible pain). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Time-Weighted SPID as Recorded on a NPRS 0 to 24 Hours (SPID24) After the First Dose of Study Drug
|
31.54 units on a scale
Standard Error 5.57
|
40.95 units on a scale
Standard Error 5.52
|
34.36 units on a scale
Standard Error 7.45
|
24.78 units on a scale
Standard Error 5.44
|
45.22 units on a scale
Standard Error 5.52
|
SECONDARY outcome
Timeframe: From Baseline at 48 Hours After First Dose of Study DrugPopulation: FAS.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 30% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP or placebo was reported.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 30 Percent (%) Reduction in NPRS at 48 Hours After the First Dose of Study Drug
|
67.8 percentage of participants
|
68.3 percentage of participants
|
75.8 percentage of participants
|
62.9 percentage of participants
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline at 48 Hours After First Dose of Study DrugPopulation: FAS.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 50% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP or placebo were reported.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 50% Reduction in NPRS at 48 Hours After the First Dose of Study Drug
|
61.0 percentage of participants
|
61.7 percentage of participants
|
72.7 percentage of participants
|
56.5 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline at 48 Hours After First Dose of Study DrugPopulation: FAS.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with at least 70% reduction from baseline in NPRS at 48 hours after the first dose of VX-548, HB/APAP or placebo were reported.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least 70% Reduction in NPRS at 48 Hours After the First Dose of Study Drug
|
40.7 percentage of participants
|
50.0 percentage of participants
|
51.5 percentage of participants
|
38.7 percentage of participants
|
51.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: Pharmacokinetic (PK) analysis set included participants who received at least 1 dose of VX-548. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=62 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=60 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite)
VX-548: Day 1
|
0.119 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0536
|
0.311 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0864
|
0.523 micrograms/milliliter (mcg/mL)
Standard Deviation 0.193
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite)
VX-548: Day 2
|
0.118 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0426
|
0.337 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0951
|
0.503 micrograms/milliliter (mcg/mL)
Standard Deviation 0.126
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite)
M6-548: Day 1
|
0.0929 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0363
|
0.234 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0781
|
0.385 micrograms/milliliter (mcg/mL)
Standard Deviation 0.114
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of VX-548 and M6-548 (Metabolite)
M6-548: Day 2
|
0.183 micrograms/milliliter (mcg/mL)
Standard Deviation 0.0520
|
0.483 micrograms/milliliter (mcg/mL)
Standard Deviation 0.130
|
0.787 micrograms/milliliter (mcg/mL)
Standard Deviation 0.210
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: PK analysis set included participants who received at least 1 dose of VX-548. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=62 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=60 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite)
VX-548: Day 1
|
2.20 hours (h)
Interval 0.967 to 6.0
|
2.17 hours (h)
Interval 1.0 to 5.98
|
2.09 hours (h)
Interval 1.0 to 6.03
|
—
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite)
VX-548: Day 2
|
1.93 hours (h)
Interval 0.867 to 7.87
|
1.97 hours (h)
Interval 0.85 to 6.0
|
2.00 hours (h)
Interval 0.667 to 5.98
|
—
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite)
M6-548: Day 1
|
6.00 hours (h)
Interval 1.08 to 12.0
|
5.95 hours (h)
Interval 2.0 to 12.2
|
6.02 hours (h)
Interval 1.92 to 12.1
|
—
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-548 and M6-548 (Metabolite)
M6-548: Day 2
|
5.88 hours (h)
Interval 1.0 to 8.05
|
4.28 hours (h)
Interval 1.0 to 12.0
|
4.20 hours (h)
Interval 1.7 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: PK analysis set included participants who received at least 1 dose of VX-548. Here, "Number Analyzed" signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo
n=33 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=62 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=60 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite)
VX-548: Day 1
|
0.650 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.173
|
1.84 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.451
|
2.95 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.745
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite)
VX-548: Day 2
|
0.885 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.248
|
2.54 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.731
|
3.72 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.873
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite)
M6-548: Day 1
|
0.845 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.337
|
2.23 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.753
|
3.53 hour*mcg/ml (h*mcg/mL)
Standard Deviation 1.13
|
—
|
—
|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VX-548 and M6-548 (Metabolite)
M6-548: Day 2
|
1.94 hour*mcg/ml (h*mcg/mL)
Standard Deviation 0.577
|
5.12 hour*mcg/ml (h*mcg/mL)
Standard Deviation 1.41
|
8.27 hour*mcg/ml (h*mcg/mL)
Standard Deviation 2.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 16Population: Safety set included all participants who had received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 Participants
Participants received HB 5 mg/ APAP 325 mg every q6h for 2 days.
|
VX-548: Low Dose
n=33 Participants
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 Participants
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 Participants
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
23 Participants
|
25 Participants
|
7 Participants
|
17 Participants
|
18 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
HB/APAP
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
VX-548: Low Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VX-548: Mid Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VX-548: High Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=59 participants at risk
Participants received placebo matched to VX-548 and HB/APAP for 2 days.
|
HB/APAP
n=60 participants at risk
Participants received HB 5 mg/ APAP 325 mg q6h for 2 days.
|
VX-548: Low Dose
n=33 participants at risk
Participants received VX-548 20 mg as first dose, followed by VX-548 10 mg q12h for 2 days.
|
VX-548: Mid Dose
n=62 participants at risk
Participants received VX-548 60 mg as first dose, followed by VX-548 30 mg q12h for 2 days.
|
VX-548: High Dose
n=60 participants at risk
Participants received VX-548 100 mg as first dose, followed by VX-548 50 mg q12h for 2 days.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.5%
5/59 • Day 1 up to Day 16
|
18.3%
11/60 • Day 1 up to Day 16
|
6.1%
2/33 • Day 1 up to Day 16
|
4.8%
3/62 • Day 1 up to Day 16
|
8.3%
5/60 • Day 1 up to Day 16
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Day 1 up to Day 16
|
5.0%
3/60 • Day 1 up to Day 16
|
0.00%
0/33 • Day 1 up to Day 16
|
0.00%
0/62 • Day 1 up to Day 16
|
0.00%
0/60 • Day 1 up to Day 16
|
|
Nervous system disorders
Headache
|
11.9%
7/59 • Day 1 up to Day 16
|
6.7%
4/60 • Day 1 up to Day 16
|
0.00%
0/33 • Day 1 up to Day 16
|
6.5%
4/62 • Day 1 up to Day 16
|
8.3%
5/60 • Day 1 up to Day 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER