Trial Outcomes & Findings for A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (NCT NCT05437419)
NCT ID: NCT05437419
Last Updated: 2024-10-15
Results Overview
To evaluate the safety and tolerability of multiple oral doses of TCK-276 or placebo in patients with rheumatoid arthritis (RA)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
42 days (duration of study)
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Cohort 1
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Cohort 1
n=6 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=6 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
n=8 Participants
The patient will receive matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
32 participants
n=10 Participants
|
|
Height
|
163.5 cm
STANDARD_DEVIATION 3.6472 • n=5 Participants
|
163.03 cm
STANDARD_DEVIATION 5.8745 • n=7 Participants
|
160.167 cm
STANDARD_DEVIATION 6.4936 • n=5 Participants
|
165.533 cm
STANDARD_DEVIATION 11.6610 • n=4 Participants
|
164.878 cm
STANDARD_DEVIATION 5.2737 • n=21 Participants
|
163.515 cm
STANDARD_DEVIATION 6.800 • n=10 Participants
|
|
Weight
|
74.950 kg
STANDARD_DEVIATION 7.5688 • n=5 Participants
|
73.252 kg
STANDARD_DEVIATION 6.6383 • n=7 Participants
|
75.102 kg
STANDARD_DEVIATION 5.3800 • n=5 Participants
|
80.678 kg
STANDARD_DEVIATION 9.3768 • n=4 Participants
|
73.829 kg
STANDARD_DEVIATION 4.5924 • n=21 Participants
|
75.454 kg
STANDARD_DEVIATION 6.8510 • n=10 Participants
|
|
BMI
|
28.035 kg/m2
STANDARD_DEVIATION 2.5991 • n=5 Participants
|
27.605 kg/m2
STANDARD_DEVIATION 2.6567 • n=7 Participants
|
29.278 kg/m2
STANDARD_DEVIATION 1.3073 • n=5 Participants
|
29.438 kg/m2
STANDARD_DEVIATION 1.5542 • n=4 Participants
|
27.219 kg/m2
STANDARD_DEVIATION 2.2859 • n=21 Participants
|
28.247 kg/m2
STANDARD_DEVIATION 2.2170 • n=10 Participants
|
PRIMARY outcome
Timeframe: 42 days (duration of study)To evaluate the safety and tolerability of multiple oral doses of TCK-276 or placebo in patients with rheumatoid arthritis (RA)
Outcome measures
| Measure |
Cohort 1
n=6 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=6 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
n=8 Participants
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Number ot Participants With Treatment Emergent Adverse Events
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 with time-concentration profile
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Cmax TCK-276 day 1
|
28.6 ng/mL
Standard Deviation 22.4
|
60.6 ng/mL
Standard Deviation 27.0
|
195 ng/mL
Standard Deviation 146
|
417 ng/mL
Standard Deviation 222
|
—
|
|
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Cmax TCK-276 day 7
|
30.8 ng/mL
Standard Deviation 13.4
|
61.4 ng/mL
Standard Deviation 20.0
|
158 ng/mL
Standard Deviation 76.1
|
402 ng/mL
Standard Deviation 107
|
—
|
|
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Cmax TEI-W00595 day 1
|
8.41 ng/mL
Standard Deviation 4.98
|
28.7 ng/mL
Standard Deviation 9.20
|
93.6 ng/mL
Standard Deviation 90.2
|
176 ng/mL
Standard Deviation 98.5
|
—
|
|
Cmax: Plasma Concentrations of TCK-276 and TEI-W00595 (Metabolite)
Cmax TEI-W00595 day 7
|
12.7 ng/mL
Standard Deviation 4.55
|
30.3 ng/mL
Standard Deviation 8.47
|
92.4 ng/mL
Standard Deviation 60.3
|
161 ng/mL
Standard Deviation 55.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
To evaluate tmax as pharmacokinetic (PK) variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
TCK-276 Day 7
|
2 h
Interval 1.5 to 4.0
|
2.47 h
Interval 1.5 to 4.08
|
2 h
Interval 0.5 to 4.0
|
2.5 h
Interval 1.0 to 4.0
|
—
|
|
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
TEI-W00595 Day 1
|
4 h
Interval 2.0 to 12.0
|
4 h
Interval 1.0 to 23.92
|
4 h
Interval 0.75 to 12.0
|
3 h
Interval 2.0 to 8.0
|
—
|
|
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
TCK-276 Day 1
|
2 h
Interval 1.0 to 12.0
|
3 h
Interval 0.5 to 6.0
|
3 h
Interval 0.75 to 12.0
|
1.75 h
Interval 1.0 to 8.0
|
—
|
|
Tmax: Time of Maximum Plasma Concentration Determined Directly From the Concentration-time Profile
TEI-W00595 Day 7
|
4 h
Interval 2.0 to 4.0
|
3.5 h
Interval 2.0 to 15.93
|
3 h
Interval 3.0 to 4.0
|
3 h
Interval 2.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
To evaluate t½ as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
t½: Terminal Elimination Half-life
TCK-276 Day 7
|
13.6 h
Standard Deviation 5.46
|
11.4 h
Standard Deviation 6.15
|
13.6 h
Standard Deviation 7.73
|
11.0 h
Standard Deviation 4.39
|
—
|
|
t½: Terminal Elimination Half-life
TEI-W00595 Day 7
|
9.10 h
Standard Deviation 5.73
|
10.7 h
Standard Deviation 6.42
|
12.8 h
Standard Deviation 5.28
|
11.7 h
Standard Deviation 4.69
|
—
|
|
t½: Terminal Elimination Half-life
TCK-276 Day 1
|
6.61 h
Standard Deviation 2.53
|
4.49 h
Standard Deviation 1.36
|
5.14 h
Standard Deviation 0.937
|
7.13 h
Standard Deviation 1.67
|
—
|
|
t½: Terminal Elimination Half-life
TEI-W00595 Day 1
|
4.78 h
Standard Deviation 0.716
|
5.15 h
Standard Deviation 1.60
|
5.53 h
Standard Deviation 1.27
|
5.49 h
Standard Deviation 1.28
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
To evaluate AUCtau as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
TCK-276 Day 1
|
125 h*ng/mL
Standard Deviation 20.3
|
341 h*ng/mL
Standard Deviation 68.1
|
1150 h*ng/mL
Standard Deviation 653
|
1530 h*ng/mL
Standard Deviation 660
|
—
|
|
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
TEI-W00595 Day 7
|
91.2 h*ng/mL
Standard Deviation 15.4
|
247 h*ng/mL
Standard Deviation 59.1
|
788 h*ng/mL
Standard Deviation 566
|
1200 h*ng/mL
Standard Deviation 414
|
—
|
|
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
TCK-276 Day 7
|
172 h*ng/mL
Standard Deviation 32.8
|
363 h*ng/mL
Standard Deviation 48.6
|
1050 h*ng/mL
Standard Deviation 520
|
2220 h*ng/mL
Standard Deviation 542
|
—
|
|
AUCtau: Area Under the Plasma Concentration-time Curve Over a Dosing Interval, Tau = 24 Hours
TEI-W00595 Day 1
|
70.3 h*ng/mL
Standard Deviation 13.5
|
231 h*ng/mL
Standard Deviation 65.4
|
890 h*ng/mL
Standard Deviation 718
|
1270 h*ng/mL
Standard Deviation 772
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
AUC0-inf:Area under the plasma concentration time curve from pre-dose (time 0) extrapolated to infinite time (Days 1 and 7)
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
TCK-276 Day 1
|
132 h*ng/mL
Standard Deviation 23.6
|
390 h*ng/mL
Standard Deviation 124
|
1230 h*ng/mL
Standard Deviation 792
|
1830 h*ng/mL
Standard Deviation 632
|
—
|
|
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
TCK-276 Day 7
|
205 h*ng/mL
Standard Deviation 43.5
|
426 h*ng/mL
Standard Deviation 94.0
|
1380 h*ng/mL
Standard Deviation 802
|
2680 h*ng/mL
Standard Deviation 789
|
—
|
|
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
TEI-W00595 Day 1
|
74.2 h*ng/mL
Standard Deviation 14.2
|
246 h*ng/mL
Standard Deviation 68.2
|
1010 h*ng/mL
Standard Deviation 880
|
1590 h*ng/mL
Standard Deviation 882
|
—
|
|
AUC0-inf: Area Under the Plasma Concentration Time Curve From Pre-dose (Time 0) Extrapolated to Infinite Time
TEI-W00595 Day 7
|
105 h*ng/mL
Standard Deviation 28.7
|
295 h*ng/mL
Standard Deviation 87.6
|
1050 h*ng/mL
Standard Deviation 752
|
1480 h*ng/mL
Standard Deviation 586
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
To evaluate CL/F as PK variables of TCK-276 in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Clearance (CL)/F: Apparent Total Body Clearance (Parent Only)
TCK-276 Day 1
|
77.5 L/h
Standard Deviation 14.0
|
68.9 L/h
Standard Deviation 20.8
|
103 L/h
Standard Deviation 102
|
103 L/h
Standard Deviation 31.1
|
—
|
|
Clearance (CL)/F: Apparent Total Body Clearance (Parent Only)
TCK-276 Day 7
|
59.5 L/h
Standard Deviation 10.1
|
70.0 L/h
Standard Deviation 9.62
|
102 L/h
Standard Deviation 83.2
|
83.0 L/h
Standard Deviation 21.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
To evaluate Vz/F as PK variables of TCK-276 in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Vz/F: Apparent Volume of Distribution Based on Terminal Phase (Parent Only)
TCK-276 Day 1
|
702 L
Standard Deviation 175
|
457 L
Standard Deviation 213
|
813 L
Standard Deviation 877
|
1010 L
Standard Deviation 221
|
—
|
|
Vz/F: Apparent Volume of Distribution Based on Terminal Phase (Parent Only)
TCK-276 Day 7
|
1150 L
Standard Deviation 456
|
1150 L
Standard Deviation 573
|
1510 L
Standard Deviation 571
|
1280 L
Standard Deviation 399
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
To evaluate MRT0-inf as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
MRT0-inf: Mean Residence Time Extrapolated to Infinity
TCK-276 Day 1
|
7.65 h
Standard Deviation 2.67
|
9.74 h
Standard Deviation 5.36
|
7.56 h
Standard Deviation 2.11
|
6.46 h
Standard Deviation 0.479
|
—
|
|
MRT0-inf: Mean Residence Time Extrapolated to Infinity
TCK-276 Day 7
|
10.8 h
Standard Deviation 1.42
|
11.3 h
Standard Deviation 3.38
|
14.5 h
Standard Deviation 6.71
|
11.4 h
Standard Deviation 2.81
|
—
|
|
MRT0-inf: Mean Residence Time Extrapolated to Infinity
TEI-W00595 Day 1
|
9.09 h
Standard Deviation 3.26
|
9.07 h
Standard Deviation 2.40
|
9.66 h
Standard Deviation 2.34
|
9.21 h
Standard Deviation 3.14
|
—
|
|
MRT0-inf: Mean Residence Time Extrapolated to Infinity
TEI-W00595 Day 7
|
11.2 h
Standard Deviation 2.25
|
12.2 h
Standard Deviation 4.36
|
15.5 h
Standard Deviation 5.96
|
12.9 h
Standard Deviation 3.30
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Racc (Cmax) calculated as Cmax on Day 7/Cmax on Day 1.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Racc (Cmax): Accumulation Ratio Based on Cmax
TCK-276 Day 7 vs Day 1
|
1.72 Ratio
Standard Deviation 1.69
|
1.22 Ratio
Standard Deviation 0.736
|
1.19 Ratio
Standard Deviation 1.06
|
1.21 Ratio
Standard Deviation 0.725
|
—
|
|
Racc (Cmax): Accumulation Ratio Based on Cmax
TEI-W00595 Day 7 vs Day 1
|
1.85 Ratio
Standard Deviation 1.09
|
1.08 Ratio
Standard Deviation 0.242
|
1.26 Ratio
Standard Deviation 0.547
|
1.10 Ratio
Standard Deviation 0.463
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Racc (AUCtau) calculated as AUCtau on Day 7/AUCtau on Day 1. To evaluate Racc (AUCtau) as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Racc (AUCtau): Accumulation Ratio Based on AUCtau
TCK-276 Day 7 vs Day 1
|
1.37 Ratio
Standard Deviation 0.146
|
1.12 Ratio
Standard Deviation 0.286
|
0.960 Ratio
Standard Deviation 0.231
|
1.43 Ratio
Standard Deviation 0.288
|
—
|
|
Racc (AUCtau): Accumulation Ratio Based on AUCtau
TEI-W00595 Day 7 vs Day 1
|
1.33 Ratio
Standard Deviation 0.170
|
1.07 Ratio
Standard Deviation 0.252
|
0.971 Ratio
Standard Deviation 0.256
|
1.13 Ratio
Standard Deviation 0.357
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Molar metabolic ratio of Cmax calculated as (Cmax \[metabolite\] × molecular weight of parent)/(Cmax \[parent\] × molecular weight of metabolite).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Metabolic Ratio (MR) for Cmax
Day 7 Metabolite vs Parent
|
0.412 Ratio
Standard Deviation 0.106
|
0.490 Ratio
Standard Deviation 0.115
|
0.537 Ratio
Standard Deviation 0.147
|
0.383 Ratio
Standard Deviation 0.0937
|
—
|
|
Metabolic Ratio (MR) for Cmax
Day 1 Metabolite vs Parent
|
0.349 Ratio
Standard Deviation 0.166
|
0.499 Ratio
Standard Deviation 0.191
|
0.448 Ratio
Standard Deviation 0.190
|
0.403 Ratio
Standard Deviation 0.115
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Molar metabolic ratio of AUC calculated as (AUC \[metabolite\] × molecular weight of parent)/(AUC \[parent\] × molecular weight of metabolite). To evaluate MR AUC as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
MR for Area Under the Plasma Concentration-time Curve (AUC)Tau
Metabolite vs Parent Day 1
|
0.542 Ratio
Standard Deviation 0.0559
|
0.656 Ratio
Standard Deviation 0.102
|
0.669 Ratio
Standard Deviation 0.173
|
0.540 Ratio
Standard Deviation 0.0959
|
—
|
|
MR for Area Under the Plasma Concentration-time Curve (AUC)Tau
Metabolite vs Parent Day 7
|
0.514 Ratio
Standard Deviation 0.0489
|
0.658 Ratio
Standard Deviation 0.0759
|
0.675 Ratio
Standard Deviation 0.187
|
0.511 Ratio
Standard Deviation 0.0879
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Molar metabolic ratio of AUC calculated as (AUC \[metabolite\] × molecular weight of parent)/(AUC \[parent\] × molecular weight of metabolite) 0-inf. To evaluate MR AUC 0-inf as PK variables of TCK-276 and its metabolite in patients with RA after multiple ascending dose (MAD) administration
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
MR for Area Under the Plasma Concentration-time Curve (AUC)0-inf
Metabolite vs Parent Day 1
|
0.542 Ratio
Standard Deviation 0.0579
|
0.654 Ratio
Standard Deviation 0.0941
|
0.697 Ratio
Standard Deviation 0.200
|
0.567 Ratio
Standard Deviation 0.0942
|
—
|
|
MR for Area Under the Plasma Concentration-time Curve (AUC)0-inf
Metabolite vs Parent Day 7
|
0.495 Ratio
Standard Deviation 0.0561
|
0.641 Ratio
Standard Deviation 0.0653
|
0.677 Ratio
Standard Deviation 0.184
|
0.519 Ratio
Standard Deviation 0.103
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Ae 0-24: Amount of study drug excreted unchanged in the urine (Days 1 and 7) over 24 hours
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Ae 0-24: Amount of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
TCK-276 Day 1
|
0.194 mg
Standard Deviation 0.0847
|
0.529 mg
Standard Deviation 0.318
|
2.02 mg
Standard Deviation 1.19
|
2.04 mg
Standard Deviation 1.14
|
—
|
|
Ae 0-24: Amount of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
TCK-276 Day 7
|
0.203 mg
Standard Deviation 0.0847
|
1.68 mg
Standard Deviation 2.46
|
1.47 mg
Standard Deviation 0.537
|
2.07 mg
Standard Deviation 0.781
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Fe 0-24: Percentage of study drug excreted unchanged in the urine (Days 1 and 7) over 24 hours
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Fe 0-24: Percentage of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
TCK-276 Day 1
|
1.94 percentage of drug
Standard Deviation 0.847
|
2.11 percentage of drug
Standard Deviation 1.27
|
2.70 percentage of drug
Standard Deviation 1.58
|
1.17 percentage of drug
Standard Deviation 0.651
|
—
|
|
Fe 0-24: Percentage of Study Drug Excreted Unchanged in the Urine (Days 1 and 7)
TCK-276 Day 7
|
2.03 percentage of drug
Standard Deviation 0.847
|
2.33 percentage of drug
Standard Deviation 1.67
|
1.96 percentage of drug
Standard Deviation 0.716
|
1.19 percentage of drug
Standard Deviation 0.446
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7Population: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
CLr: Renal clearance Day 1 and Day 7 (24 hours)
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Clearance Renal (CLr): Renal Clearance (Days 1 and 7)
TCK-276 Day 7
|
1.15 L/h
Standard Deviation 0.422
|
1.47 L/h
Standard Deviation 1.02
|
1.41 L/h
Standard Deviation 0.576
|
0.850 L/h
Standard Deviation 0.351
|
—
|
|
Clearance Renal (CLr): Renal Clearance (Days 1 and 7)
TCK-276 Day 1
|
1.67 L/h
Standard Deviation 0.442
|
1.89 L/h
Standard Deviation 0.814
|
2.09 L/h
Standard Deviation 1.09
|
0.985 L/h
Standard Deviation 0.286
|
—
|
SECONDARY outcome
Timeframe: Day 7 0-72 hoursPopulation: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Ae 0-72: Amount of study drug excreted unchanged in the urine (Day 7) over a 72 hour period
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Ae 0-72: Amount of Study Drug Excreted Unchanged in the Urine (Day 7)
|
0.229 mg
Standard Deviation 0.0952
|
2.05 mg
Standard Deviation 3.28
|
1.61 mg
Standard Deviation 0.616
|
2.21 mg
Standard Deviation 0.868
|
—
|
SECONDARY outcome
Timeframe: Day 7 0-72 hoursPopulation: One subject each from Cohorts 1 and 3 was excluded due to the occurrence of an event that met the definition of exclusion from the PK analysis.
Fe 0-72: Percentage of study drug excreted unchanged in the urine on Day 7 (72 hours)
Outcome measures
| Measure |
Cohort 1
n=5 Participants
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 Participants
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=5 Participants
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 Participants
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Fe 0-72: Percentage of Study Drug Excreted Unchanged in the Urine
|
2.29 percentage of drug
Standard Deviation 0.952
|
2.45 percentage of drug
Standard Deviation 1.70
|
2.15 percentage of drug
Standard Deviation 0.822
|
1.26 percentage of drug
Standard Deviation 0.496
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pooled Placebo Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=6 participants at risk
The patient will receive 10 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 2
n=6 participants at risk
The patient will receive 25 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Cohort 3
n=6 participants at risk
The patient will receive 75 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
.
|
Cohort 4
n=6 participants at risk
The patient will receive 175 mg of TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
Pooled Placebo Group
n=8 participants at risk
The patient will receive matching placebo for TCK-276 orally from Day 1 to Day 7 (once daily (QD) under fed conditions).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sinus Tachycardia
|
16.7%
1/6 • Number of events 2 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
12.5%
1/8 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Eye disorders
Ocular hyperaemia
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Eye disorders
Ulcerative keratitis
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
12.5%
1/8 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/6 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
0.00%
0/8 • Any adverse events (AEs) occurring after the subject signed the informed consent form (ICF) were collected and monitored throughout the study via safety assessments, observation, and subject reporting. Period of time included a 28 day screening period, a 10 day treatment period and a 4 day follow up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place