Trial Outcomes & Findings for A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants (NCT NCT05852340)

Last Updated: 2024-10-16

Results Overview

AUCinf was defined as area under the plasma-concentration time profile from time zero extrapolated to infinite time. AUCinf for ritlecitinib was calculated by 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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.

Results posted on

2024-10-16

Participant Flow

This is a phase 1, open-label, single dose, randomized 4-crossover periods (periods 1-4) and 1-fixed period (period 5) design study. A total of 12 participants were randomized and assigned to receive the study intervention.

Participant milestones

Participant milestones
Measure	Sequence 1: Treatment A-> B-> C-> D-> E Participants were randomized to receive ritlecitinib 30 milligram (mg) intact blend-in capsule (BiC) in fasted state on Day 1 of Period 1 (Treatment A). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.	Sequence 2: Treatment B-> D-> A-> C-> E Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state on Day 1 of Period 1 (Treatment B). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.	Sequence 3: Treatment C-> A-> D-> B-> E Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state on Day 1 of Period 1 (Treatment C). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.	Sequence 4: Treatment D-> C-> B-> A-> E Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state on Day 1 of Period 1 (Treatment D). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.
Period 1 STARTED	3	3	3	3
Period 1 COMPLETED	3	3	3	3
Period 1 NOT COMPLETED	0	0	0	0
Period 2 STARTED	3	3	3	3
Period 2 COMPLETED	3	3	3	3
Period 2 NOT COMPLETED	0	0	0	0
Period 3 STARTED	3	3	3	3
Period 3 COMPLETED	3	3	3	3
Period 3 NOT COMPLETED	0	0	0	0
Period 4 STARTED	3	3	3	3
Period 4 COMPLETED	3	3	3	3
Period 4 NOT COMPLETED	0	0	0	0
Period 5 STARTED	3	3	3	3
Period 5 COMPLETED	3	2	3	2
Period 5 NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1: Treatment A-> B-> C-> D-> E Participants were randomized to receive ritlecitinib 30 milligram (mg) intact blend-in capsule (BiC) in fasted state on Day 1 of Period 1 (Treatment A). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.	Sequence 2: Treatment B-> D-> A-> C-> E Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state on Day 1 of Period 1 (Treatment B). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.	Sequence 3: Treatment C-> A-> D-> B-> E Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state on Day 1 of Period 1 (Treatment C). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state (Treatment D). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.	Sequence 4: Treatment D-> C-> B-> A-> E Participants were randomized to receive contents of ritlecitinib 30 mg BiC sprinkled on applesauce in fasted state on Day 1 of Period 1 (Treatment D). Period 1 was followed by Period 2. On Day 1 of Period 2, participants received contents of ritlecitinib 30 mg BiC sprinkled on yoghurt in fasted state (Treatment C). Period 2 was followed by Period 3. On Day 1 of Period 3, participants received contents of ritlecitinib 30 mg BiC sprinkled on strawberry jam in fasted state (Treatment B). Period 3 was followed by Period 4. On Day 1 of Period 4, participants received ritlecitinib 30 mg intact BiC in fasted state (Treatment A). Period 4 was followed by Period 5. On Day 1 of Period 5, participants received ritlecitinib 30 mg intact BiC given with high fat meal (Treatment E). Dosing of each period was separated by at least a 48-hour washout interval. Participants were followed up for up to 35 days after the last administration of ritlecitinib.
Period 5 Not completing the meal	0	1	0	0
Period 5 Adverse Event	0	0	0	1

Baseline Characteristics

A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants All participants who were enrolled in the study.
Age, Continuous	40.4 Years STANDARD_DEVIATION 12.99 • n=5 Participants
Age, Customized 26-35 years	6 Participants n=5 Participants
Age, Customized 36-45 years	3 Participants n=5 Participants
Age, Customized >45 years	3 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose on Day 1 of each period. Each treatment period lasted 24 hours. Dosing of each period was separated by at least a 48-hour washout interval.

Population: All participants randomized and treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.

Outcome measures

Outcome measures
Measure	Ritlecitinib 30 mg Capsule (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with strawberry jam under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with yoghurt under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with applesauce under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Given With High Fat Meal n=9 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule given with high fat meal on Day 1 of each Period.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Ritlecitinib	389.1 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 32	398.3 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 31	378.0 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 27	387.8 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 27	387.0 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 23

PRIMARY outcome

Population: All participants randomized and treated who had at least 1 of the PK parameters of primary interest.

Cmax was defined as maximum observed plasma concentration. Cmax for ritlecitinib was observed directly from data.

Outcome measures

Outcome measures
Measure	Ritlecitinib 30 mg Capsule (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with strawberry jam under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with yoghurt under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with applesauce under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Given With High Fat Meal n=10 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule given with high fat meal on Day 1 of each Period.
Maximum Observed Concentration (Cmax) of Ritlecitinib	244.3 ng/mL Geometric Coefficient of Variation 35	236.1 ng/mL Geometric Coefficient of Variation 28	206.6 ng/mL Geometric Coefficient of Variation 24	229.4 ng/mL Geometric Coefficient of Variation 25	108.0 ng/mL Geometric Coefficient of Variation 28

SECONDARY outcome

Timeframe: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)

Population: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Ritlecitinib 30 mg Capsule (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with strawberry jam under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Yoghurt (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with yoghurt under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Mixed With Applesauce (Fasted) n=12 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule mixed with applesauce under fasted conditions on Day 1 of each Period.	Ritlecitinib 30 mg Capsule Given With High Fat Meal n=10 Participants Participants received a single oral dose of ritlecitinib 30 mg capsule given with high fat meal on Day 1 of each Period.
Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs) Number of participants with all-causality TEAEs	5 Participants	2 Participants	4 Participants	4 Participants	2 Participants
Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs) Number of participants with all-causality SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs) Number of participants with treatment-related TEAEs	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With All-Causality and Treatment-Related Treatment Emergent Adverse Events (TEAEs) Number of participants with treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose of study treatment up to 28-35 days after last dose of study treatment (ie, up to 45 days)

Population: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.

Hematology included hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, etc. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, etc. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy. Laboratory abnormalities were judged by the investigator. Laboratory abnormalities reported for at least 1 participant in the whole study are presented here.