Trial Outcomes & Findings for Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants (NCT NCT05338502)
NCT ID: NCT05338502
Last Updated: 2024-10-30
Results Overview
PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3
Results posted on
2024-10-30
Participant Flow
This is a fixed sequence study where participants receive Selpercatinib in Period 1, Selpercatinib in combination with Ranitidine in Period 2, and Selpercatinib in combination with Omeprazole in Period 3.
Participant milestones
| Measure |
160 mg Selpercatinib
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
Participants received 150 mg ranitidine twice a day (BID) orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
Period 1 - Day 1 to Day 8
STARTED
|
20
|
0
|
0
|
|
Period 1 - Day 1 to Day 8
Received at Least One Dose of Study Drug
|
20
|
0
|
0
|
|
Period 1 - Day 1 to Day 8
COMPLETED
|
20
|
0
|
0
|
|
Period 1 - Day 1 to Day 8
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2 - Day 8 to Day 19
STARTED
|
0
|
20
|
0
|
|
Period 2 - Day 8 to Day 19
COMPLETED
|
0
|
17
|
0
|
|
Period 2 - Day 8 to Day 19
NOT COMPLETED
|
0
|
3
|
0
|
|
Period 3 - Day 19 to Day 29
STARTED
|
0
|
0
|
17
|
|
Period 3 - Day 19 to Day 29
COMPLETED
|
0
|
0
|
17
|
|
Period 3 - Day 19 to Day 29
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
160 mg Selpercatinib
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
Participants received 150 mg ranitidine twice a day (BID) orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
Period 2 - Day 8 to Day 19
Withdrawal by Subject
|
0
|
2
|
0
|
|
Period 2 - Day 8 to Day 19
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for AUC0-t.
PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
|
21600 hour*nanograms per milliliter(h*ng/mL)
Geometric Coefficient of Variation 31.4
|
19100 hour*nanograms per milliliter(h*ng/mL)
Geometric Coefficient of Variation 31.9
|
21000 hour*nanograms per milliliter(h*ng/mL)
Geometric Coefficient of Variation 27.4
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for AUC0-inf.
PK: AUC0-inf of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=19 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib
|
21800 h*ng/mL
Geometric Coefficient of Variation 31.2
|
19900 h*ng/mL
Geometric Coefficient of Variation 33.5
|
21100 h*ng/mL
Geometric Coefficient of Variation 27.4
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for %AUCextrap.
PK: %AUCextrap of Selpercatinib
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=19 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib
|
0.337 percentage of (%) of AUCextrap
Interval 0.136 to 3.0
|
0.818 percentage of (%) of AUCextrap
Interval 0.137 to 2.02
|
0.612 percentage of (%) of AUCextrap
Interval 0.103 to 1.59
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for Cmax.
PK: Cmax of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=19 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Maximum Observed Plasma Concentration (Cmax) of Selpercatinib
|
1650 ng/mL
Geometric Coefficient of Variation 58.4
|
1330 ng/mL
Geometric Coefficient of Variation 67.8
|
1220 ng/mL
Geometric Coefficient of Variation 63.4
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for tmax.
PK: Tmax of Selpercatinib
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=19 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Time of Maximum Observed Concentration (Tmax) of Selpercatinib
|
2.00 hour
Interval 1.0 to 3.0
|
1.83 hour
Interval 1.0 to 24.0
|
3.00 hour
Interval 1.5 to 6.0
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for Vz/F.
PK: Vz/F of Selpercatinib
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=19 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Apparent Volume of Distribution (Vz/F)
|
259 liter
Geometric Coefficient of Variation 44.2
|
331 liter
Geometric Coefficient of Variation 59.1
|
300 liter
Geometric Coefficient of Variation 48.6
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for CL/F.
PK: CL/F of Selpercatinib
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=19 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib
|
7.35 liter per hour (L/h)
Geometric Coefficient of Variation 31.2
|
8.03 liter per hour (L/h)
Geometric Coefficient of Variation 33.5
|
7.58 liter per hour (L/h)
Geometric Coefficient of Variation 27.4
|
PRIMARY outcome
Timeframe: PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3Population: All enrolled or randomized participants who received at least one dose of study drug with evaluable data for t½.
PK: t½ of Selpercatinib
Outcome measures
| Measure |
160 mg Selpercatinib
n=20 Participants
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=18 Participants
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 Participants
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
PK: Apparent Terminal Elimination Half-life (t½) of Selpercatinib
|
24.4 hour
Geometric Coefficient of Variation 35.4
|
29.3 hour
Geometric Coefficient of Variation 33.5
|
27.4 hour
Geometric Coefficient of Variation 30.1
|
Adverse Events
160 mg Selpercatinib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
150 mg Ranitidine Dosed With 160 mg Selpercatinib
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
40 mg Omeprazole Dosed With 160 mg Selpercatinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
160 mg Selpercatinib
n=20 participants at risk
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1).
|
150 mg Ranitidine Dosed With 160 mg Selpercatinib
n=20 participants at risk
Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12).
|
40 mg Omeprazole Dosed With 160 mg Selpercatinib
n=17 participants at risk
Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.8%
2/17 • Number of events 2 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.8%
2/17 • Number of events 2 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/17 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/17 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 2 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
25.0%
1/4 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/3 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/16 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
2/20 • Number of events 3 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/17 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
1/17 • Number of events 1 • Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER