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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 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 3

Results posted on

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

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

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

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 3

Population: 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

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 3

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

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

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

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

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

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

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

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)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Ritlecitinib 100 mg MR1 Capsules (Fasted)

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Ritlecitinib 100 mg MR2 Capsules (Fasted)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Ritlecitinib 100 mg MR1 Capsules (Fed)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ritlecitinib 100 mg MR2 Capsules (Fed)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

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