Trial Outcomes & Findings for A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers (NCT NCT05830799)
NCT ID: NCT05830799
Last Updated: 2025-01-03
Results Overview
Maximum observed concentration (Cmax) for caffeine and its metabolite paraxanthine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)
Results posted on
2025-01-03
Participant Flow
Subjects were recruited from CTC's database of volunteers and from strategic marketing campaigns (including social media).
In total, 36 prospective trial subjects were screened for inclusion. Of these, 14 subjects were screening failures (ineligible), 2 subjects withdrew consent, and 1 subject met the eligibility criteria but was not needed. Nineteen (19) subjects were included in the trial. Of the 19 included subjects, 18 subjects were fully evaluable, i.e., completed the trial up until at least the end of Day 19.
Participant milestones
| Measure |
Experimental: C21
C21, single dose, oral administration twice daily, for 15 days
Drug Drug Interaction: The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Experimental: C21
C21, single dose, oral administration twice daily, for 15 days
Drug Drug Interaction: The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Trial to Evaluate the Impact of C21 on the Exposure of 4 Substrates in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Experimental: C21
n=19 Participants
C21, single dose, oral administration twice daily, for 15 days
Drug Drug Interaction: The intervention phase consists of 3 periods: in period 1, the pharmacokinetics (PK) of all substrates will be evaluated in the absence of C21, in period 2, a potential inhibitory effect of C21 on the substrates be evaluated, and in period 3, the net effect of potential C21-mediated induction and inhibition on the substrates will be evaluated
|
|---|---|
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Age, Continuous
|
38.9 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 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
Sweden
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Maximum observed concentration (Cmax) for caffeine and its metabolite paraxanthine.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (Cmax)
Caffeine
|
2290 ng/mL
Geometric Coefficient of Variation 22.3
|
2871 ng/mL
Geometric Coefficient of Variation 18.7
|
2784 ng/mL
Geometric Coefficient of Variation 37.1
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (Cmax)
Paraxanthine
|
546.4 ng/mL
Geometric Coefficient of Variation 15.6
|
191.0 ng/mL
Geometric Coefficient of Variation 43.5
|
467.7 ng/mL
Geometric Coefficient of Variation 24.2
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Time of occurrence of Cmax (Tmax) for caffeine and its metabolite paraxanthine.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (Tmax)
Caffeine
|
0.6333 hours
Interval 0.5 to 1.0
|
0.7500 hours
Interval 0.25 to 2.0
|
0.5167 hours
Interval 0.25 to 4.0
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (Tmax)
Paraxanthine
|
6.000 hours
Interval 2.0 to 12.0
|
23.93 hours
Interval 12.0 to 24.0
|
11.90 hours
Interval 1.0 to 23.5
|
PRIMARY outcome
Timeframe: Day 2 to day 19Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for caffeine and its metabolite paraxanthine.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (AUC0-last)
Caffeine
|
15760 h*ng/mL
Geometric Coefficient of Variation 39.8
|
47560 h*ng/mL
Geometric Coefficient of Variation 14.7
|
34690 h*ng/mL
Geometric Coefficient of Variation 46.0
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (AUC0-last)
Paraxanthine
|
8667 h*ng/mL
Geometric Coefficient of Variation 21.4
|
3013 h*ng/mL
Geometric Coefficient of Variation 46.1
|
8285 h*ng/mL
Geometric Coefficient of Variation 25.3
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to infinity (AUC0-inf) for caffeine and its metabolite paraxanthine.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (AUC0-inf)
Caffeine
|
16880 h*ng/mL
Geometric Coefficient of Variation 43.5
|
130500 h*ng/mL
Geometric Coefficient of Variation 37.8
|
50190 h*ng/mL
Geometric Coefficient of Variation 79.5
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Caffeine and Paraxanthine (AUC0-inf)
Paraxanthine
|
11020 h*ng/mL
Geometric Coefficient of Variation 35.8
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA Explanation: Not calculated. Due to the shape of the paraxanthine plasma concentration vs. time curves in periods 2 and 3, Lambdaz could only be calculated for 2 subjects, hence summary statistics for the Lambdaz-dependent PK parameter AUC0-inf could not be calculated.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
NA Explanation: Not calculated. Due to the shape of the paraxanthine plasma concentration vs. time curves in periods 2 and 3, Lambdaz could only be calculated for 2 subjects, hence summary statistics for the Lambdaz-dependent PK parameter AUC0-inf could not be calculated.
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Maximum observed concentration (Cmax) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (Cmax)
Tolbutamide
|
48390 ng/mL
Geometric Coefficient of Variation 9.75
|
61070 ng/mL
Geometric Coefficient of Variation 15.2
|
64130 ng/mL
Geometric Coefficient of Variation 15.4
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (Cmax)
4-Hydroxy-Tolbutamide
|
670.5 ng/mL
Geometric Coefficient of Variation 27.8
|
25.49 ng/mL
Geometric Coefficient of Variation 83.0
|
88.71 ng/mL
Geometric Coefficient of Variation 63.5
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (Cmax)
Carboxy-Tolbutamide
|
2040 ng/mL
Geometric Coefficient of Variation 25.2
|
81.35 ng/mL
Geometric Coefficient of Variation 96.2
|
256.3 ng/mL
Geometric Coefficient of Variation 76.4
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Time of occurrence of Cmax (Tmax) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (Tmax)
Tolbutamide
|
2.500 hours
Interval 1.5 to 4.1
|
4.000 hours
Interval 2.0 to 24.0
|
4.000 hours
Interval 1.5 to 8.02
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (Tmax)
4-Hydroxy-Tolbutamide
|
4.000 hours
Interval 2.0 to 8.02
|
15.23 hours
Interval 8.0 to 24.0
|
11.91 hours
Interval 8.0 to 23.7
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (Tmax)
Carboxy-Tolbutamide
|
4.000 hours
Interval 2.0 to 6.0
|
11.98 hours
Interval 8.0 to 24.0
|
11.90 hours
Interval 8.0 to 23.7
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (AUC0-last)
Tolbutamide
|
449800 h*ng/mL
Geometric Coefficient of Variation 15.8
|
1146000 h*ng/mL
Geometric Coefficient of Variation 16.3
|
1207000 h*ng/mL
Geometric Coefficient of Variation 18.8
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (AUC0-last)
4-Hydroxy-Tolbutamide
|
6872 h*ng/mL
Geometric Coefficient of Variation 23.6
|
316.8 h*ng/mL
Geometric Coefficient of Variation 51.6
|
960.5 h*ng/mL
Geometric Coefficient of Variation 47.7
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (AUC0-last)
Carboxy-Tolbutamide
|
21800 h*ng/mL
Geometric Coefficient of Variation 20.7
|
1034 h*ng/mL
Geometric Coefficient of Variation 62.3
|
2729 h*ng/mL
Geometric Coefficient of Variation 59.3
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to infinity (AUC0-inf) for Tolbutamide and its metabolites 4-hydroxy-tolbutamide and carboxy-tolbutamide.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (AUC0-inf)
4-Hydroxy-Tolbutamide
|
8142 h*ng/mL
Geometric Coefficient of Variation 24.1
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Not calculated. Due to the shape of the 4-hydroxy-tolbutamide and carboxy-tolbutamide plasma concentration vs. time curves in periods 2 and 3, Lambdaz could not be calculated and subsequently, summary statistics for the Lambdaz-dependent PK parameter AUC0-inf for the tolbutamide metabolites in these trial periods could not be calculated.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Not calculated. Due to the shape of the 4-hydroxy-tolbutamide and carboxy-tolbutamide plasma concentration vs. time curves in periods 2 and 3, Lambdaz could not be calculated and subsequently, summary statistics for the Lambdaz-dependent PK parameter AUC0-inf for the tolbutamide metabolites in these trial periods could not be calculated.
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (AUC0-inf)
Tolbutamide
|
499100 h*ng/mL
Geometric Coefficient of Variation 19.3
|
9919000 h*ng/mL
Geometric Coefficient of Variation 71.2
|
6134000 h*ng/mL
Geometric Coefficient of Variation 69.2
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Tolbutamide and 4-hydroxy-tolbutamide and Carboxy-tolbutamide (AUC0-inf)
Carboxy-Tolbutamide
|
24790 h*ng/mL
Geometric Coefficient of Variation 18.0
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Not calculated. Due to the shape of the 4-hydroxy-tolbutamide and carboxy-tolbutamide plasma concentration vs. time curves in periods 2 and 3, Lambdaz could not be calculated and subsequently, summary statistics for the Lambdaz-dependent PK parameter AUC0-inf for the tolbutamide metabolites in these trial periods could not be calculated.
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Not calculated. Due to the shape of the 4-hydroxy-tolbutamide and carboxy-tolbutamide plasma concentration vs. time curves in periods 2 and 3, Lambdaz could not be calculated and subsequently, summary statistics for the Lambdaz-dependent PK parameter AUC0-inf for the tolbutamide metabolites in these trial periods could not be calculated.
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Maximum observed concentration (Cmax) for midazolam and its metabolite 1-hydroxy-midazolam.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (Cmax)
Midazolam
|
10.89 ng/mL
Geometric Coefficient of Variation 33.1
|
14.32 ng/mL
Geometric Coefficient of Variation 36.4
|
12.69 ng/mL
Geometric Coefficient of Variation 25.8
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (Cmax)
1-Hydroxy-Midazolam
|
3.187 ng/mL
Geometric Coefficient of Variation 50.2
|
3.175 ng/mL
Geometric Coefficient of Variation 52.5
|
2.570 ng/mL
Geometric Coefficient of Variation 50.9
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Time of occurrence of Cmax (Tmax) for midazolam and its metabolite 1-hydroxy-midazolam.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (Tmax)
Midazolam
|
0.7500 hours
Interval 0.5 to 0.783
|
0.7500 hours
Interval 0.5 to 1.0
|
0.7500 hours
Interval 0.5 to 1.0
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (Tmax)
1-Hydroxy-Midazolam
|
0.7500 hours
Interval 0.5 to 1.0
|
0.7500 hours
Interval 0.5 to 1.5
|
0.7500 hours
Interval 0.5 to 1.0
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for midazolam and its metabolite 1-hydroxy-midazolam.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (AUC0-last)
Midazolam
|
29.17 h*ng/mL
Geometric Coefficient of Variation 39.6
|
42.06 h*ng/mL
Geometric Coefficient of Variation 35.4
|
35.09 h*ng/mL
Geometric Coefficient of Variation 28.9
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (AUC0-last)
1-Hydroxy-Midazolam
|
7.835 h*ng/mL
Geometric Coefficient of Variation 41.9
|
8.695 h*ng/mL
Geometric Coefficient of Variation 39.6
|
6.465 h*ng/mL
Geometric Coefficient of Variation 41.4
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24 hours post dose at Day 2 (period 1), Day 5 (period 2) and Day 18 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to to infinity (AUC0-inf) for midazolam and its metabolite 1-hydroxy-midazolam.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (AUC0-inf)
Midazolam
|
30.41 h*ng/mL
Geometric Coefficient of Variation 39.7
|
43.77 h*ng/mL
Geometric Coefficient of Variation 35.8
|
36.58 h*ng/mL
Geometric Coefficient of Variation 28.9
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Midazolam and 1-hydroxy-midazolam (AUC0-inf)
1-Hydroxy-Midazolam
|
8.700 h*ng/mL
Geometric Coefficient of Variation 39.7
|
9.756 h*ng/mL
Geometric Coefficient of Variation 39.3
|
7.316 h*ng/mL
Geometric Coefficient of Variation 40.2
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 hours post dose at Day 1 (period 1), Day 4 (period 2) and Day 17 (period 3)Population: PK analysis set.
Maximum observed concentration (Cmax) for nintedanib and its metabolite BIBF 1202.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (Cmax)
Nintedanib
|
10.10 ng/mL
Geometric Coefficient of Variation 80.4
|
13.87 ng/mL
Geometric Coefficient of Variation 79.0
|
13.72 ng/mL
Geometric Coefficient of Variation 61.3
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (Cmax)
BIBF 1202
|
12.03 ng/mL
Geometric Coefficient of Variation 97.7
|
15.16 ng/mL
Geometric Coefficient of Variation 66.7
|
13.61 ng/mL
Geometric Coefficient of Variation 90.8
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 hours post dose at Day 1 (period 1), Day 4 (period 2) and Day 17 (period 3)Population: PK analysis set.
Time of occurrence of Cmax (Tmax) for nintedanib and its metabolite BIBF 1202.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (Tmax)
Nintedanib
|
3.000 hours
Interval 1.0 to 6.07
|
3.000 hours
Interval 1.0 to 6.0
|
2.000 hours
Interval 0.767 to 6.0
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (Tmax)
BIBF 1202
|
4.000 hours
Interval 2.0 to 6.02
|
4.000 hours
Interval 1.52 to 6.0
|
3.033 hours
Interval 2.0 to 6.0
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 hours post dose at Day 1 (period 1), Day 4 (period 2) and Day 17 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) for nintedanib and its metabolite BIBF 1202.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (AUC0-last)
Nintedanib
|
92.87 h*ng/mL
Geometric Coefficient of Variation 82.3
|
128.4 h*ng/mL
Geometric Coefficient of Variation 57.9
|
106.4 h*ng/mL
Geometric Coefficient of Variation 48.2
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (AUC0-last)
BIBF 1202
|
103.1 h*ng/mL
Geometric Coefficient of Variation 102
|
133.1 h*ng/mL
Geometric Coefficient of Variation 59.1
|
106.8 h*ng/mL
Geometric Coefficient of Variation 68.8
|
PRIMARY outcome
Timeframe: Pre-dose and 0:15, 0:30, 0:45, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 hours post dose at Day 1 (period 1), Day 4 (period 2) and Day 17 (period 3)Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to infinity (AUC0-inf) for nintedanib and its metabolite BIBF 1202.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (AUC0-inf)
Nintedanib
|
101.0 h*ng/mL
Geometric Coefficient of Variation 80.3
|
143.3 h*ng/mL
Geometric Coefficient of Variation 56.2
|
114.7 h*ng/mL
Geometric Coefficient of Variation 47.4
|
|
To Evaluate the Impact of C21 on the Pharmacokinetics (PK) of Nintedanib and BIBF 1202 (AUC0-inf)
BIBF 1202
|
110.1 h*ng/mL
Geometric Coefficient of Variation 98.9
|
141.8 h*ng/mL
Geometric Coefficient of Variation 58.9
|
113.8 h*ng/mL
Geometric Coefficient of Variation 63.6
|
SECONDARY outcome
Timeframe: Day 17Population: PK analysis set.
Maximum observed concentration (Cmax) of C21 and its main metabolite M1.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (Cmax)
C21
|
1433 ng/mL
Geometric Coefficient of Variation 55.7
|
—
|
—
|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (Cmax)
M1
|
421.6 ng/mL
Geometric Coefficient of Variation 29.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 17Population: PK analysis set.
Time of occurrence of Cmax (Tmax) of C21 and its main metabolite M1.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (Tmax)
C21
|
1.000 hours
Interval 0.5 to 2.0
|
—
|
—
|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (Tmax)
M1
|
3.000 hours
Interval 2.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 17Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to time of last measurable plasma concentration (AUC0-last) of C21 and its main metabolite M1.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (AUC0-last)
C21
|
2041 h*ng/mL
Geometric Coefficient of Variation 30.4
|
—
|
—
|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (AUC0-last)
M1
|
2731 h*ng/mL
Geometric Coefficient of Variation 37.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 17Population: PK analysis set.
Area under the plasma concentration vs. time curve from 0 to the end of the dosing interval (AUC0-tau) of C21 and its main metabolite M1.
Outcome measures
| Measure |
Period 1 - Without C21
n=18 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (AUC0-tau)
C21
|
2049 h*ng/mL
Geometric Coefficient of Variation 30.3
|
—
|
—
|
|
To Evaluate the Pharmacokinetics (PK) of C21 and M1 (AUC0-tau)
M1
|
2734 h*ng/mL
Geometric Coefficient of Variation 37.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From signing ICF to Day 25Population: Full analysis set.
Frequency, seriousness and intensity of adverse events (AEs).
Outcome measures
| Measure |
Period 1 - Without C21
n=19 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 Participants
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 Participants
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Safety of C21 (AEs)
Severity - Life-Threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Any AE
|
8 Participants
|
10 Participants
|
5 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Any AE leading to withdrawal from trial
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Any AE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - C21 - Related
|
0 Participants
|
7 Participants
|
3 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - C21 - Not Related
|
1 Participants
|
5 Participants
|
13 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - C21 - Not Applicable
|
7 Participants
|
0 Participants
|
2 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Nintedanib - Related
|
4 Participants
|
5 Participants
|
2 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Nintedanib - Not Related
|
4 Participants
|
7 Participants
|
2 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Nintedanib - Not Applicable
|
0 Participants
|
2 Participants
|
1 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Caffeine - Related
|
1 Participants
|
5 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Caffeine - Not Related
|
3 Participants
|
8 Participants
|
3 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Caffeine - Not Applicable
|
4 Participants
|
2 Participants
|
3 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Tolbutamide - Related
|
1 Participants
|
5 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Tolbutamide - Not Related
|
3 Participants
|
8 Participants
|
4 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Tolbutamide - Not Applicable
|
4 Participants
|
2 Participants
|
3 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Midazolam - Related
|
1 Participants
|
5 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Midazolam - Not Related
|
3 Participants
|
8 Participants
|
4 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Causality - Midazolam - Not Applicable
|
4 Participants
|
2 Participants
|
3 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Severity - Mild
|
7 Participants
|
9 Participants
|
4 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Severity - Moderate
|
1 Participants
|
3 Participants
|
1 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Severity - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate the Safety of C21 (AEs)
Severity - Death
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening to day 25Population: Full analysis set.
Number of patients with clinically significant changes in vital signs (systolic and diastolic blood pressure and pulse) from baseline. Any vital signs outside of normal ranges were judged as clinically significant or not clinically significant
Outcome measures
| Measure |
Period 1 - Without C21
n=19 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Safety of C21 (Vital Signs)
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to day 25Population: Full analysis set.
Number of patients with clinically significant changes in electrocardiogram (ECG) from baseline. The resting heart rate (HR) and PQ/PR, QRS, QT and QTcF intervals were recorded. Any abnormalities were specified and documented as clinically significant or not clinically significant
Outcome measures
| Measure |
Period 1 - Without C21
n=19 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Safety of C21 (ECG)
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to day 25Population: Full analysis set.
Number of patients with clinically significant changes in clinical laboratory measurements (haematology, clinical chemistry, coagulation) from baseline. Any laboratory values outside of normal ranges were specified and documented as normal, abnormal not clinically significant, or abnormal clinically significant.
Outcome measures
| Measure |
Period 1 - Without C21
n=19 Participants
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
To Evaluate the Safety of C21 (Clinical Laboratory Measurements)
|
0 Participants
|
—
|
—
|
Adverse Events
Period 1 - Without C21
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Period 2 - With C21
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Period 3 - With C21
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1 - Without C21
n=19 participants at risk
In period 1 (Day 1 to Day 3), the pharmacokinetics (PK) of all substrates were evaluated in the absence of C21.
|
Period 2 - With C21
n=18 participants at risk
In period 2 (Day 4 to Day 6), a potential inhibitory effect of C21 on the substrates was evaluated.
|
Period 3 - With C21
n=18 participants at risk
In period 3 (Day 17 to Day 19), the net effect of potential C21-mediated induction and inhibition on the substrates was evaluated.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • From signing ICF to Day 25
|
11.1%
2/18 • Number of events 2 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/19 • From signing ICF to Day 25
|
16.7%
3/18 • Number of events 3 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • Number of events 3 • From signing ICF to Day 25
|
11.1%
2/18 • Number of events 2 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/19 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • From signing ICF to Day 25
|
16.7%
3/18 • Number of events 3 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • From signing ICF to Day 25
|
16.7%
3/18 • Number of events 5 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 2 • From signing ICF to Day 25
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • From signing ICF to Day 25
|
11.1%
2/18 • Number of events 2 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • Number of events 3 • From signing ICF to Day 25
|
27.8%
5/18 • Number of events 8 • From signing ICF to Day 25
|
11.1%
2/18 • Number of events 2 • From signing ICF to Day 25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/19 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Infections and infestations
Rhinitis
|
5.3%
1/19 • Number of events 1 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/19 • From signing ICF to Day 25
|
0.00%
0/18 • From signing ICF to Day 25
|
5.6%
1/18 • Number of events 1 • From signing ICF to Day 25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place