Trial Outcomes & Findings for A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults (NCT NCT06172348)
NCT ID: NCT06172348
Last Updated: 2025-04-10
Results Overview
COMPLETED
PHASE1
12 participants
For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3
2025-04-10
Participant Flow
Participants received treatment in Period 1, 2 or 3 under fasted condition and in Period 4 under fed condition.
Participant milestones
| Measure |
Treatment Sequence 1: A Then B Then C Then B (Fed)
Participants were randomized to receive ritlecitinib 100 milligrams (mg) single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as modified release1 (MR1) capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 2: B Then C Then A Then B (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 3: C Then A Then B Then B (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 4: A Then B Then C Then C (Fed)
Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 5: B Then C Then A Then C (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 6: C Then A Then B Then C (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Treatment Period 2
COMPLETED
|
2
|
2
|
1
|
2
|
2
|
2
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
2
|
2
|
1
|
2
|
2
|
2
|
|
Treatment Period 3
COMPLETED
|
2
|
2
|
1
|
2
|
2
|
2
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
2
|
2
|
1
|
2
|
2
|
2
|
|
Treatment Period 4
COMPLETED
|
2
|
2
|
1
|
2
|
2
|
2
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1: A Then B Then C Then B (Fed)
Participants were randomized to receive ritlecitinib 100 milligrams (mg) single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as modified release1 (MR1) capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 2: B Then C Then A Then B (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 3: C Then A Then B Then B (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 4: A Then B Then C Then C (Fed)
Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 5: B Then C Then A Then C (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 6: C Then A Then B Then C (Fed)
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
|---|---|---|---|---|---|---|
|
Treatment Period 2
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Learn About Three Forms of The Study Medicine (Ritlecitinib) in Healthy Adults
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: A Then B Then C Then B (Fed)
n=2 Participants
Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 2: B Then C Then A Then B (Fed)
n=2 Participants
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 3: C Then A Then B Then B (Fed)
n=2 Participants
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 4: A Then B Then C Then C (Fed)
n=2 Participants
Participants were randomized to receive ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 5: B Then C Then A Then C (Fed)
n=2 Participants
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Treatment Sequence 6: C Then A Then B Then C (Fed)
n=2 Participants
Participants were randomized to receive ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fasted state on Day 1 of Period 3; then ritlecitinib 100 mg single oral dose as oral solution \[A\] in fasted state on Day 1 of Period 1; then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR1 capsules \[B\] in fasted state on Day 1 of Period 2; and then ritlecitinib 100 mg (2\*50 mg) single oral dose as MR2 capsules \[C\] in fed state of Period 4. Between 2 doses of consecutive periods there was a gap of at least 48 hours.
|
Total
n=12 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3Population: Pharmacokinetic (PK) parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Ritlecitinib: MR Capsules vs Oral Solution Under Fasted Condition
|
671.6 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
145.1 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
84.96 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
PRIMARY outcome
Timeframe: For oral solution: Pre-dose (0 hours), 0.5, 1, 2, 3, 4, 6, 10, 12 and 24 hours post-dose on Day 1 of Period 1, 2 or 3; for MR1 and MR2 capsules: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2 or 3Population: PK parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period.
AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Ritlecitinib: MR Capsules vs Oral Solution Under Fasted Condition
|
1261 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
1067 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
970.6 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2, 3 (for fasted) or 4 (for fed)Population: PK parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=5 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=6 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Cmax of Ritlecitinib: MR Capsules Under Fed vs Fasted Condition
|
145.1 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
84.96 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
177.1 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16
|
112.0 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours), 1, 2, 3, 4, 6, 10, 12,16, 24, 36 and 48 hours post-dose on Day 1 of Period 1, 2, 3 (for fasted) or 4 (for fed)Population: PK parameter set included all participants who had at least 1 PK parameter of interest quantified in at least 1 treatment period.
AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=5 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=6 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
AUCinf of Ritlecitinib: MR Capsules Under Fed vs Fasted Condition
|
1067 Nanogram*Hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 28
|
970.6 Nanogram*Hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 22
|
1168 Nanogram*Hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 20
|
1036 Nanogram*Hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 15
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)Population: Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=5 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=6 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days)Population: Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory parameters included: Hematology: lymphocytes/leukocytes, eosinophils/leukocytes greater than (\>) 1.2\*upper limit of normal (ULN) (percent \[%\]), neutrophils/leukocytes less than (\<) 0.8\*lower limit of normal (LLN) (%); Urinalysis: urine hemoglobin, nitrite greater than or equal to (\>=) 1, bacteria \> 20 (per high power field \[/HPF\]). Clinical significance was judged by investigator.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=5 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=6 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Test Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days)Population: Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position. Criteria for vital signs included: SBP: value less than (\<) 90 millimeter of mercury (mmHg), change greater than or equal to (\>=) 30 mmHg decrease, change \>= 30 mmHg increase; DBP: value \< 50 mmHg, change \>= 20 mmHg decrease, change \>= 20 mmHg increase; PR: value \< 40 beats per minute (bpm), value \> 120 bpm. Clinical significance was judged by investigator.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=5 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=6 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to Day 3 of Period 4 (maximum up to Day 12, each Period = 3 days)Population: Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT, corrected QT (Fridericia method) (QTcF) and QRS intervals. Clinical significance was judged by investigator.
Outcome measures
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsule (Fasted)
n=11 Participants
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fasted)
n=12 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=5 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsule (Fed)
n=6 Participants
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Ritlecitinib 100 mg Oral Solution (Fasted)
Ritlecitinib 100 mg MR1 Capsules (Fasted)
Ritlecitinib 100 mg MR2 Capsules (Fasted)
Ritlecitinib 100 mg MR1 Capsules (Fed)
Ritlecitinib 100 mg MR2 Capsules (Fed)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ritlecitinib 100 mg Oral Solution (Fasted)
n=12 participants at risk
Participants received Ritlecitinib 100 mg as oral solution under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsules (Fasted)
n=11 participants at risk
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR2 Capsules (Fasted)
n=12 participants at risk
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fasted conditions on Day 1 of either Period 1, 2, or 3.
|
Ritlecitinib 100 mg MR1 Capsules (Fed)
n=5 participants at risk
Participants received Ritlecitinib 100 mg as oral MR1 capsules under fed conditions on Day 1 of Period 4.
|
Ritlecitinib 100 mg MR2 Capsules (Fed)
n=6 participants at risk
Participants received Ritlecitinib 100 mg as oral MR2 capsules under fed conditions on Day 1 of Period 4.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
8.3%
1/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
9.1%
1/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
General disorders
Chills
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
9.1%
1/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
General disorders
Vessel puncture site pain
|
8.3%
1/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
9.1%
1/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
9.1%
1/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
9.1%
1/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
9.1%
1/11 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
3/12 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • From start of study treatment up to 35 days after administration of last dose of study intervention (maximum up to 45 days)
Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER