Trial Outcomes & Findings for A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy (NCT NCT03764072)
NCT ID: NCT03764072
Last Updated: 2022-02-09
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). SPID24 was calculated from 0 to 24 hours and the score range was -240 (worst score) to 240 (best score).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
0 to 24 Hours After First Dose
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
|
VX-150 - Dose Level 2
Participants received VX-150 1000 mg once daily (qd) for 2 days.
|
VX-150 - Dose Level 3
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
42
|
44
|
45
|
46
|
27
|
|
Overall Study
COMPLETED
|
46
|
42
|
43
|
45
|
45
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
Participants received VX-150 1500 milligrams (mg) as first dose, followed by VX-150 750 mg every 12 hours (q12h) for 2 days.
|
VX-150 - Dose Level 2
Participants received VX-150 1000 mg once daily (qd) for 2 days.
|
VX-150 - Dose Level 3
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal of consent (due to lack of efficacy)
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of consent (for other reason)
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Pain Intensity at Baseline (at 0 hours) as Recorded on Numeric Pain Rating Scale (NPRS)
|
6.5 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.7 • n=4 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 1.3 • n=21 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.6 • n=8 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 1.7 • n=8 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 14.21 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 13.03 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 12.18 • n=4 Participants
|
47.2 years
STANDARD_DEVIATION 11.51 • n=21 Participants
|
48.7 years
STANDARD_DEVIATION 12.92 • n=8 Participants
|
46.2 years
STANDARD_DEVIATION 12.81 • n=8 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
217 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
168 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
14 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
188 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 Hours After First DosePopulation: 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). 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=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Time-weighted Sum of the Pain Intensity Difference as Recorded on Numeric Pain Rating Scale (NPRS) 0 to 24 Hours (SPID24) After First Dose
|
19.1 units on a scale
Standard Deviation 49.7
|
37.3 units on a scale
Standard Deviation 45.6
|
32.3 units on a scale
Standard Deviation 51.2
|
30.5 units on a scale
Standard Deviation 46.9
|
27.5 units on a scale
Standard Deviation 37.8
|
28.3 units on a scale
Standard Deviation 43.6
|
SECONDARY outcome
Timeframe: 0 to 48 Hours After First DosePopulation: 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). 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=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Time-weighted Sum of Pain Intensity Difference as Recorded on NPRS 0 to 48 Hours (SPID48) After First Dose
|
77.4 units on a scale
Standard Deviation 105.2
|
112.5 units on a scale
Standard Deviation 88.4
|
106.1 units on a scale
Standard Deviation 109.6
|
101.5 units on a scale
Standard Deviation 103.2
|
90.9 units on a scale
Standard Deviation 81.9
|
100.0 units on a scale
Standard Deviation 102.6
|
SECONDARY outcome
Timeframe: From Baseline at 24 Hours After First DosePopulation: FAS.
Pain intensity was recorded on 11-point ordinal 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 24 hours after the first dose of VX-150 or placebo were reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least 30 Percent (%) Reduction in NPRS at 24 Hours After First Dose of VX-150 Versus Placebo
|
50.0 percentage of participants
|
59.5 percentage of participants
|
56.8 percentage of participants
|
55.6 percentage of participants
|
63.0 percentage of participants
|
51.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline at 24 Hours After First DosePopulation: FAS.
Pain intensity was recorded on 11-point ordinal 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 24 hours after the first dose of VX-150 or placebo were reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least 50% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
|
41.3 percentage of participants
|
38.1 percentage of participants
|
45.5 percentage of participants
|
44.4 percentage of participants
|
45.7 percentage of participants
|
40.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline at 24 Hours After First DosePopulation: FAS.
Pain intensity was recorded on 11-point ordinal 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 24 hours after the first dose of VX-150 or placebo were reported.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants With at Least 70% Reduction in NPRS at 24 Hours After the First Dose of VX-150 Versus Placebo
|
21.7 percentage of participants
|
21.4 percentage of participants
|
34.1 percentage of participants
|
22.2 percentage of participants
|
30.4 percentage of participants
|
18.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 hours After the First DosePopulation: FAS.
Time to onset of confirmed perceptible pain relief (time to onset of perceptible pain relief \[any pain relief at all after the first dose\] for participants who had meaningful pain relief \[relief that is meaningful to participants after the first dose\] reported based on the stopwatch assessment.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Time to Onset of Confirmed Perceptible Pain Relief After First Dose of VX-150 Versus Placebo
|
20.4 minutes
Interval 6.0 to 67.0
|
29.6 minutes
Interval 6.0 to 115.0
|
23.8 minutes
Interval 11.0 to 92.0
|
20.2 minutes
Interval 7.0 to 103.0
|
35.6 minutes
Interval 2.0 to 112.0
|
25.2 minutes
Interval 17.0 to 102.0
|
SECONDARY outcome
Timeframe: Up to 6 Hours After the First DosePopulation: FAS.
Time to onset of meaningful pain relief (relief that is meaningful to participants after the first dose) reported based on the stopwatch assessment.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Time to Onset of Meaningful Pain Relief After the First Dose of VX-150 Versus Placebo
|
55.4 minutes
Interval 19.0 to 102.0
|
58.7 minutes
Interval 16.0 to 175.0
|
68.6 minutes
Interval 15.0 to 255.0
|
49.9 minutes
Interval 20.0 to 355.0
|
61.5 minutes
Interval 10.0 to 294.0
|
64.5 minutes
Interval 30.0 to 162.0
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: Pharmacokinetic (PK) set included all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=44 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=45 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=46 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=27 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
VRT- 1207355: Day 1
|
4.97 micrograms per milliliter (mcg/mL)
Standard Deviation 1.67
|
3.27 micrograms per milliliter (mcg/mL)
Standard Deviation 1.35
|
1.71 micrograms per milliliter (mcg/mL)
Standard Deviation 0.536
|
1.89 micrograms per milliliter (mcg/mL)
Standard Deviation 0.641
|
0.794 micrograms per milliliter (mcg/mL)
Standard Deviation 0.241
|
—
|
|
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
VRT- 1207355: Day 2
|
4.93 micrograms per milliliter (mcg/mL)
Standard Deviation 1.38
|
4.17 micrograms per milliliter (mcg/mL)
Standard Deviation 1.53
|
3.00 micrograms per milliliter (mcg/mL)
Standard Deviation 0.979
|
1.95 micrograms per milliliter (mcg/mL)
Standard Deviation 0.708
|
0.974 micrograms per milliliter (mcg/mL)
Standard Deviation 0.305
|
—
|
|
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
VRT- 1268114: Day 1
|
1.79 micrograms per milliliter (mcg/mL)
Standard Deviation 0.637
|
1.31 micrograms per milliliter (mcg/mL)
Standard Deviation 0.602
|
0.699 micrograms per milliliter (mcg/mL)
Standard Deviation 0.261
|
0.719 micrograms per milliliter (mcg/mL)
Standard Deviation 0.341
|
0.295 micrograms per milliliter (mcg/mL)
Standard Deviation 0.128
|
—
|
|
Maximum Observed Concentration (Cmax) of VRT- 1207355 (Active Moiety) and VRT- 1268114 (Metabolite M5)
VRT- 1268114: Day 2
|
2.68 micrograms per milliliter (mcg/mL)
Standard Deviation 0.944
|
1.87 micrograms per milliliter (mcg/mL)
Standard Deviation 0.779
|
1.65 micrograms per milliliter (mcg/mL)
Standard Deviation 0.544
|
1.11 micrograms per milliliter (mcg/mL)
Standard Deviation 0.437
|
0.408 micrograms per milliliter (mcg/mL)
Standard Deviation 0.153
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 2Population: PK set. Here, "number analyzed" signifies those participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=44 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=45 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=46 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=27 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
VRT- 1207355: Day 1
|
39.7 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 13.4
|
25.7 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 11.0
|
13.6 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 4.60
|
14.6 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 4.73
|
5.99 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 1.68
|
—
|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
VRT- 1268114: Day 1
|
13.7 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 4.40
|
10.2 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 4.84
|
5.55 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 2.04
|
5.48 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 2.58
|
2.27 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 1.01
|
—
|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
VRT- 1268114: Day 2
|
26.8 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 9.60
|
17.6 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 7.33
|
16.2 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 4.72
|
10.8 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 4.19
|
3.84 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 1.39
|
—
|
|
Area Under the Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12h) of VRT- 1207355 and VRT- 1268114
VRT- 1207355: Day 2
|
46.1 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 14.0
|
36.1 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 12.8
|
27.1 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 8.40
|
17.7 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 6.01
|
8.24 microgram*hour per milliliter (mcg*h/mL)
Standard Deviation 2.80
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to Day 10Population: Safety set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 Participants
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 Participants
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 Participants
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 Participants
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 Participants
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants With AEs
|
15 participants
|
16 participants
|
19 participants
|
18 participants
|
19 participants
|
12 participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants With SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VX-150 - Dose Level 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
VX-150 - Dose Level 2
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
VX-150 - Dose Level 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
VX-150 - Dose Level 4
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
VX-150 - Dose Level 5
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=46 participants at risk
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 participants at risk
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 participants at risk
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 participants at risk
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 participants at risk
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 participants at risk
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/46 • Day 1 up to Day 10
|
0.00%
0/42 • Day 1 up to Day 10
|
0.00%
0/44 • Day 1 up to Day 10
|
0.00%
0/45 • Day 1 up to Day 10
|
0.00%
0/46 • Day 1 up to Day 10
|
3.7%
1/27 • Day 1 up to Day 10
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/46 • Day 1 up to Day 10
|
0.00%
0/42 • Day 1 up to Day 10
|
0.00%
0/44 • Day 1 up to Day 10
|
0.00%
0/45 • Day 1 up to Day 10
|
0.00%
0/46 • Day 1 up to Day 10
|
3.7%
1/27 • Day 1 up to Day 10
|
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Participants received placebo matched to VX-150 for 2 days.
|
VX-150 - Dose Level 1
n=42 participants at risk
Participants received VX-150 1500 mg as first dose, followed by VX-150 750 mg q12h for 2 days.
|
VX-150 - Dose Level 2
n=44 participants at risk
Participants received VX-150 1000 mg qd for 2 days.
|
VX-150 - Dose Level 3
n=45 participants at risk
Participants received VX-150 500 mg q12h for 2 days.
|
VX-150 - Dose Level 4
n=46 participants at risk
Participants received VX-150 500 mg as first dose, followed by VX-150 250 mg q12h for 2 days.
|
VX-150 - Dose Level 5
n=27 participants at risk
Participants received VX-150 250 mg qd for 2 days.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
10.9%
5/46 • Day 1 up to Day 10
|
16.7%
7/42 • Day 1 up to Day 10
|
20.5%
9/44 • Day 1 up to Day 10
|
17.8%
8/45 • Day 1 up to Day 10
|
17.4%
8/46 • Day 1 up to Day 10
|
7.4%
2/27 • Day 1 up to Day 10
|
|
Gastrointestinal disorders
Nausea
|
6.5%
3/46 • Day 1 up to Day 10
|
9.5%
4/42 • Day 1 up to Day 10
|
11.4%
5/44 • Day 1 up to Day 10
|
11.1%
5/45 • Day 1 up to Day 10
|
10.9%
5/46 • Day 1 up to Day 10
|
11.1%
3/27 • Day 1 up to Day 10
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
2/46 • Day 1 up to Day 10
|
4.8%
2/42 • Day 1 up to Day 10
|
6.8%
3/44 • Day 1 up to Day 10
|
2.2%
1/45 • Day 1 up to Day 10
|
2.2%
1/46 • Day 1 up to Day 10
|
0.00%
0/27 • Day 1 up to Day 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER