Trial Outcomes & Findings for Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects (NCT NCT05368831)
NCT ID: NCT05368831
Last Updated: 2024-03-08
Results Overview
Evaluate the effects of NST-1024 on the pharmacokinetics (PK) (AUC0-t) of caffeine, flurbiprofen, omeprazole, metoprolol, and midazolam in healthy male and female subjects
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
15 days
Results posted on
2024-03-08
Participant Flow
Following screening, eligible participants were to receive each of the following treatments: * Day 1: Probe Drugs Cocktail #1 * Day 8: 200 mg NST-1024 + Probe Drug Cocktail #1 * Days 8 to 22: 200 mg NST-1024 once daily * Day 21: 200 mg NST-1024 + Probe Drug Cocktail #2
Participant milestones
| Measure |
All Treated Participants
All participants received each of the following treatments:
* Day 1: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam
* Day 8: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024
* Days 8 to 22: oral doses of 200 mg NST-1024 qd multiple-dose regimen
* Day 21: single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024.
|
|---|---|
|
Probe Drugs Cocktail #1
STARTED
|
24
|
|
Probe Drugs Cocktail #1
COMPLETED
|
24
|
|
Probe Drugs Cocktail #1
NOT COMPLETED
|
0
|
|
200 mg NST-1024 + Probe Drug Cocktail #1
STARTED
|
24
|
|
200 mg NST-1024 + Probe Drug Cocktail #1
COMPLETED
|
24
|
|
200 mg NST-1024 + Probe Drug Cocktail #1
NOT COMPLETED
|
0
|
|
200 mg NST-1024 (QD)
STARTED
|
24
|
|
200 mg NST-1024 (QD)
COMPLETED
|
21
|
|
200 mg NST-1024 (QD)
NOT COMPLETED
|
3
|
|
200 mg NST-1024 (QD) + Probe Cocktail #2
STARTED
|
21
|
|
200 mg NST-1024 (QD) + Probe Cocktail #2
COMPLETED
|
21
|
|
200 mg NST-1024 (QD) + Probe Cocktail #2
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Treated Participants
All participants received each of the following treatments:
* Day 1: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam
* Day 8: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024
* Days 8 to 22: oral doses of 200 mg NST-1024 qd multiple-dose regimen
* Day 21: single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024.
|
|---|---|
|
200 mg NST-1024 (QD)
Adverse Event
|
3
|
Baseline Characteristics
Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=24 Participants
* Day 1: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam
* Days 8 to 22: oral doses of 200 mg NST-1024 qd multiple-dose regimen
* Day 8: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024
* Day 21: single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024.
|
|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: PK analysis population
Evaluate the effects of NST-1024 on the pharmacokinetics (PK) (AUC0-t) of caffeine, flurbiprofen, omeprazole, metoprolol, and midazolam in healthy male and female subjects
Outcome measures
| Measure |
Probe Drugs Cocktail #1
n=23 Participants
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam on day 1. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 + Probe Drug Cocktail #1
n=23 Participants
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 8. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
n=21 Participants
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
|---|---|---|---|---|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Caffeine
|
17100 h*ng/mL
Geometric Coefficient of Variation 44.5
|
17100 h*ng/mL
Geometric Coefficient of Variation 43.4
|
17200 h*ng/mL
Geometric Coefficient of Variation 39.1
|
—
|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Paraxanthine
|
10300 h*ng/mL
Geometric Coefficient of Variation 29.4
|
9920 h*ng/mL
Geometric Coefficient of Variation 33.9
|
10500 h*ng/mL
Geometric Coefficient of Variation 35.6
|
—
|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Midazolam
|
35.3 h*ng/mL
Geometric Coefficient of Variation 39.5
|
37.9 h*ng/mL
Geometric Coefficient of Variation 28.2
|
33.0 h*ng/mL
Geometric Coefficient of Variation 43.4
|
—
|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
1-Hydroxymidazolam
|
9.99 h*ng/mL
Geometric Coefficient of Variation 44.7
|
10.3 h*ng/mL
Geometric Coefficient of Variation 50.4
|
11.6 h*ng/mL
Geometric Coefficient of Variation 24.7
|
—
|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Flurbiprofen
|
37600 h*ng/mL
Geometric Coefficient of Variation 27.3
|
34500 h*ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
—
|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Metoprolol
|
654 h*ng/mL
Geometric Coefficient of Variation 89.0
|
745 h*ng/mL
Geometric Coefficient of Variation 75.0
|
—
|
—
|
|
Evaluate the Effects of NST-1024 on the AUC0-t vs Time of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Omeprazole
|
428 h*ng/mL
Geometric Coefficient of Variation 120.8
|
432 h*ng/mL
Geometric Coefficient of Variation 140.9
|
—
|
—
|
PRIMARY outcome
Timeframe: 15 daysPopulation: PK analysis population
Evaluate the effects of NST-1024 on the PK (Cmax) of caffeine, flurbiprofen, omeprazole, metoprolol, and midazolam in healthy male and female subjects
Outcome measures
| Measure |
Probe Drugs Cocktail #1
n=23 Participants
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam on day 1. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 + Probe Drug Cocktail #1
n=23 Participants
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 8. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
n=21 Participants
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
|---|---|---|---|---|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Caffeine
|
2390 ng/mL
Geometric Coefficient of Variation 21.9
|
2390 ng/mL
Geometric Coefficient of Variation 26.4
|
2330 ng/mL
Geometric Coefficient of Variation 25.4
|
—
|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Paraxanthine
|
656 ng/mL
Geometric Coefficient of Variation 18.8
|
630 ng/mL
Geometric Coefficient of Variation 17.5
|
617 ng/mL
Geometric Coefficient of Variation 20.4
|
—
|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Midazolam
|
12.8 ng/mL
Geometric Coefficient of Variation 26.8
|
12.8 ng/mL
Geometric Coefficient of Variation 24.7
|
12.1 ng/mL
Geometric Coefficient of Variation 35.0
|
—
|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
1-Hydroxymidazolam
|
4.14 ng/mL
Geometric Coefficient of Variation 46.7
|
3.69 ng/mL
Geometric Coefficient of Variation 63.5
|
4.54 ng/mL
Geometric Coefficient of Variation 37.1
|
—
|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Flurbiprofen
|
7240 ng/mL
Geometric Coefficient of Variation 32.9
|
6480 ng/mL
Geometric Coefficient of Variation 36.4
|
—
|
—
|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Metoprolol
|
127 ng/mL
Geometric Coefficient of Variation 53.0
|
142 ng/mL
Geometric Coefficient of Variation 58.6
|
—
|
—
|
|
Evaluate the Effects of NST-1024 on the Plasma Concentration (Cmax) of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Male and Female Subjects
Omeprazole
|
221 ng/mL
Geometric Coefficient of Variation 86.9
|
189 ng/mL
Geometric Coefficient of Variation 115.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 15 daysAssess AEs and SAEs to support ongoing safety profile data
Outcome measures
| Measure |
Probe Drugs Cocktail #1
n=24 Participants
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam on day 1. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 + Probe Drug Cocktail #1
n=24 Participants
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 8. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
n=24 Participants
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
n=21 Participants
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
|---|---|---|---|---|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Overall
|
6 participants
|
6 participants
|
9 participants
|
8 participants
|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Serious
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Leading to discontinuation
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Leading to death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Severity - Mild
|
6 participants
|
6 participants
|
9 participants
|
7 participants
|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Severity - Moderate
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Assess Adverse Event (AEs) and Serious Adverse Event (SAEs) to Determine Safety Profile of NST-1024 in Healthy Subjects
Severity - Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Probe Drugs Cocktail #1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
200 mg NST-1024 + Probe Drug Cocktail #1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
200 mg NST-1024 (QD)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Probe Drugs Cocktail #1
n=24 participants at risk
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam on day 1. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 + Probe Drug Cocktail #1
n=24 participants at risk
Participants received a single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 8. Each dose was administered with approximately 240 mL of room temperature water, though additional water (up to another approximately 240 mL) was permissible. All doses were given in a fasted state.
|
200 mg NST-1024 (QD)
n=24 participants at risk
Participants received oral doses of 200 mg NST-1024 on study days 8-22. Each dose was administered with approximately 240 mL of room temperature water
|
200 mg NST-1024 (QD) + Probe Drugs Cocktail #2
n=21 participants at risk
Participants received a single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 on day 21. Each dose was administered with approximately 240 mL of room temperature water. All doses were given in a fasted state.
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
8.3%
2/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
9.5%
2/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
8.3%
2/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Change of bowel habit
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
General disorders
Application site erythema
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
General disorders
Catheter site swelling
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
General disorders
Fatigue
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
General disorders
Influenza like illness
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
General disorders
Pain
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Infections and infestations
COVID-19
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
12.5%
3/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
8.3%
2/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.8%
1/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
4.2%
1/24 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
0.00%
0/21 • From screening to up to 10 days post final dose follow up, approximately 2 months.
Whilst only 24 participants were enrolled in total, the different treatment regimens administered have been displayed as different arms/ groups to allow comparison of results between the different treatments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place