Trial Outcomes & Findings for Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib (NCT NCT06717100)
NCT ID: NCT06717100
Last Updated: 2026-08-13
Results Overview
The area under the curve will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100
Results posted on
2026-08-13
Participant Flow
Participant milestones
| Measure |
DDI Cohort
All participants will receive the same interventions at the same schedule
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
Nintedanib 150 mg (Days 1 to 7)
|
24
|
|
Overall Study
Nintedanib+LYT-100 (Days 8 to 20)
|
24
|
|
Overall Study
LYT-100 (Days 21 to 30)
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib
Baseline characteristics by cohort
| Measure |
DDI Cohort
n=24 Participants
All participants received Nintedanib 150 mg q12h on Days 1 to 7.
Participants continued to receive nintedanib 150 mg q12h and started LYT-100 275 mg TID for Days 8 to 10. Then for Days 11-13, participants continued to receive nintedanib 150 mg q12h, and LYT-100 was increased to 550 mg TID. Finally, for Days 14-20, participants continued to receive nintedanib 150 mg q12h, and LYT-100 was increased to 825 mg TID.
Participants only received LYT-100 825 mg TID on Days 21-30.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
|
Region of Enrollment
Australia
|
24 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100The area under the curve will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=21 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=19 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=23 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=21 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
AUC of LYT-100 and Nintedanib
|
54348 (h*ng/mL)
Standard Deviation 19118
|
51998 (h*ng/mL)
Standard Deviation 17709
|
206 (h*ng/mL)
Standard Deviation 105
|
257 (h*ng/mL)
Standard Deviation 132
|
37410 (h*ng/mL)
Standard Deviation 16726
|
246 (h*ng/mL)
Standard Deviation 123
|
PRIMARY outcome
Timeframe: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100The time to maximum concentration (Tmax) will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=21 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=19 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=23 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=21 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Tmax of LYT-100 and Nintedanib
|
2.00 hours
Full Range 0 • Interval 1.0 to 4.0
|
2.00 hours
Full Range 0 • Interval 1.0 to 3.5
|
2.50 hours
Full Range 0 • Interval 1.0 to 11.9
|
5.92 hours
Full Range 0 • Interval 1.5 to 10.0
|
2.00 hours
Full Range 0 • Interval 0.25 to 4.0
|
2.50 hours
Full Range 0 • Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: Blood samples for PK analysis were collected on Days 7, 13, 20, and 30 to assess the steady-state plasma PK profiles of nintedanib and/or LYT-100The maximum observed plasma concentration (Cmax) will be calculated from the first observed to last measurable plasma concentration. For nintedanib, dosing begins on Day 1 and ends on Day 20. For LYT-100, dosing begins on Day 8 and ends on Day 30.
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=21 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=19 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=23 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=21 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Cmax of LYT-100 and Nintedanib
|
12669 ng/mL
Standard Deviation 3606
|
12581 ng/mL
Standard Deviation 3371
|
36.1 ng/mL
Standard Deviation 20.3
|
38.7 ng/mL
Standard Deviation 22.0
|
8845 ng/mL
Standard Deviation 3500
|
37.2 ng/mL
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Systolic and Diastolic blood pressure measured in millimeters of mercury (mmHg) to determine if there is abnormal blood pressure
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Vital Signs (Blood Pressure)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Heart rate is measured in beats per minute (bpm) to determine if there is an abnormal heart rate
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Vital Signs (Heart Rate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Respiration rate is measured in breaths per minute (bpm) to determine if the respiration rate is abnormal
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Vital Signs (Respiration Rate)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Tympanic body temperature is measured in degrees Celsius to determine if the body temperature is abnormal
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Vital Signs (Body Temperature)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Number of participants with an abnormal ECG and/or that have a QTcF\>450 ms
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Electrocardiograms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60A physical examination is performed to determine if any physical abnormalities are detected
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Hematology parameters to be tested are hemoglobin, hematocrit, erythrocytes, platelets, and leukocytes.
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Laboratory Values (Hematology)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Serum chemistry parameters to be tested are C-reactive protein, urea, creatinine, total and direct bilirubin, urate, albumin, globulin, alkaline phosphatase, creatine phosphokinase, troponin 1, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, glucose, sodium, potassium, calcium, chloride, phosphate, bicarbonate
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Laboratory Values (Serum Chemistry)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Coagulation parameters to be tested are international normalized ratio, prothrombin time, activated partial thromboplastin time
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Laboratory Values (Coagulation)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening through Follow-up Visit on Day 60Urinalysis parameters to be tested are micro protein, nitrite, pH, trial specific gravity, ketone bodies, urobilinogen, blood, urine leukocyte esterase, appearance uri acm, micro glucose, bilirubin
Outcome measures
| Measure |
D. LYT100 825 mg (Days 14 to 20)
n=24 Participants
LYT100 825 mg (Administered on Days 14 to 20)
|
E. LYT100 825 mg (Days 21 to 30)
n=24 Participants
LYT100 825 mg (Administered on Days 21 to 30)
|
A. Nintedanib 150 mg (Days 1 to 7)
n=24 Participants
Nintedanib 150 mg (Administered on Days 1 to 7)
|
C. Nintedanib 150 mg (Days 11 to 13)
n=24 Participants
Nintedanib 150 mg (Administered on Days 11 to 13)
|
C. LYT100 550 mg (Days 11 to 13)
n=24 Participants
LYT100 550 mg (Administered on Days 11 to 13)
|
D. Nintedanib 150mg (Days 14 to 20)
n=24 Participants
Nintedanib 150mg (Administered on Days 14 to 20)
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Laboratory Values (Urinalysis)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Nintedanib 150 mg q12h (Days 1 to 7)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Nintedanib + LYT-100 150 mg q12h + TID (Days 8 to 20)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
LYT-100 825 mg TID (Days 21 to 30)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nintedanib 150 mg q12h (Days 1 to 7)
n=24 participants at risk
Participants receiving Nintedanib 150 mg q12h (Days 1 to 7)
|
Nintedanib + LYT-100 150 mg q12h + TID (Days 8 to 20)
n=24 participants at risk
Participants receiving both Nintedanib + LYT-100 150 mg q12h + TID (Days 8 to 20)
|
LYT-100 825 mg TID (Days 21 to 30)
n=22 participants at risk
Participants receiving LYT-100 825 mg TID (Days 21 to 30)
|
Overall
n=24 participants at risk
Days 1 to 30 and Follow-Up
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory infections
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
8.3%
2/24 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
General disorders
Catheter site inflammation
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
General disorders
Fatigue
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Musculoskeletal and connective tissue disorders
Exertional rhabdomyolysis
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Eye disorders
Chalazion
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Eye disorders
Eye irritation
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Investigations
Troponin increased
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Vascular disorders
Hot flush
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Infections and infestations
Viral Infection
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
8.3%
2/24 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
12.5%
3/24 • Number of events 3 • Screening through Follow-up Visit on Day 60
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
8.3%
2/24 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
8.3%
2/24 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • Screening through Follow-up Visit on Day 60
|
41.7%
10/24 • Number of events 11 • Screening through Follow-up Visit on Day 60
|
9.1%
2/22 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
58.3%
14/24 • Number of events 17 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
2/24 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
20.8%
5/24 • Number of events 5 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
29.2%
7/24 • Number of events 8 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
3/24 • Number of events 3 • Screening through Follow-up Visit on Day 60
|
16.7%
4/24 • Number of events 4 • Screening through Follow-up Visit on Day 60
|
0.00%
0/22 • Screening through Follow-up Visit on Day 60
|
29.2%
7/24 • Number of events 7 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
20.8%
5/24 • Number of events 5 • Screening through Follow-up Visit on Day 60
|
9.1%
2/22 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
20.8%
5/24 • Number of events 7 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
12.5%
3/24 • Number of events 3 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
0.00%
0/24 • Screening through Follow-up Visit on Day 60
|
4.5%
1/22 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
4.2%
1/24 • Number of events 1 • Screening through Follow-up Visit on Day 60
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • Screening through Follow-up Visit on Day 60
|
25.0%
6/24 • Number of events 7 • Screening through Follow-up Visit on Day 60
|
18.2%
4/22 • Number of events 5 • Screening through Follow-up Visit on Day 60
|
37.5%
9/24 • Number of events 14 • Screening through Follow-up Visit on Day 60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place