Trial Outcomes & Findings for A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults (NCT NCT05040295)
NCT ID: NCT05040295
Last Updated: 2023-08-21
Results Overview
Plasma AUCinf for ritlecitinib is reported. AUCinf was calculated as \[AUClast+(Clast\*/kel)\], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is 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
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, and 24 hours post dose on Day 1 in each period
Results posted on
2023-08-21
Participant Flow
A total of 12 participants were assigned to study treatment and all the participants were treated in this study.
Participant milestones
| Measure |
[Sequence 1] Ritlecitinib: Intact Adult Capsule=>Pediatric Capsules=>Spray Congealed Beads
Participants underwent 3 periods and received a single dose of study drug in each period. Participants received ritlecitinib 30 mg intact adult capsule single dose (SD) on Period 1 Day 1, followed by ritlecitinib 3\*10 mg pediatric capsules SD on Period 2 Day 1, and ritlecitinib 30 mg spray congealed beads SD on Period 3 Day 1. There was a at least 2-day washout between dosing.
|
[Sequence 2] Ritlecitinib: Pediatric Capsules=>Intact Adult Capsule=>Spray Congealed Beads
Participants underwent 3 periods and received a single dose of study drug in each period. Participants received ritlecitinib 3\*10 mg pediatric capsules SD on Period 1 Day 1, followed by ritlecitinib 30 mg intact adult capsule SD on Period 2 Day 1, and ritlecitinib spray congealed beads 30 mg on Period 3 Day 1. There was a at least 2-day washout between dosing.
|
|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
|
Period 3
COMPLETED
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=12 Participants
Includes all participants who were assigned to study treatment. Participants assigned to treatment sequence 1 received ritlecitinib 30 mg intact adult capsule SD on Period 1 Day 1, followed by ritlecitinib 3\*10 mg pediatric capsules SD on Period 2 Day 1, and ritlecitinib 30 mg spray congealed beads SD on Period 3 Day 1. Participants assigned to treatment sequence 2 received ritlecitinib 3\*10 mg pediatric capsules SD on Period 1 Day 1, followed by ritlecitinib 30 mg intact adult capsule SD on Period 2 Day 1, and ritlecitinib 30 mg spray congealed beads SD on Period 3 Day 1. There was a at least 2-day washout between dosing.
|
|---|---|
|
Age, Continuous
|
40.0 Years
n=5 Participants
|
|
Age, Customized
18-44 Years
|
8 Participants
n=5 Participants
|
|
Age, Customized
45-64 Years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, and 24 hours post dose on Day 1 in each periodPopulation: Includes all participants randomized and treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest in at least 1 treatment period.
Plasma AUCinf for ritlecitinib is reported. AUCinf was calculated as \[AUClast+(Clast\*/kel)\], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Treatment C: Ritlecitinib 30 mg Spray Congealed Beads
n=12 Participants
Participants received a single dose of ritlecitinib 30 mg spray congealed beads on Period 3 Day 1.
|
Treatment A: Ritlecitinib 30 mg Intact Adult Capsule
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 1 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 2 Day 1.
|
Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 2 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 1 Day 1.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for Ritlecitinib
|
385.1 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
361.1 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
370.1 nanograms*hours/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, and 24 hours post dose on Day 1 in each periodPopulation: Includes all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Plasma Cmax for ritlecitinib is reported.
Outcome measures
| Measure |
Treatment C: Ritlecitinib 30 mg Spray Congealed Beads
n=12 Participants
Participants received a single dose of ritlecitinib 30 mg spray congealed beads on Period 3 Day 1.
|
Treatment A: Ritlecitinib 30 mg Intact Adult Capsule
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 1 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 2 Day 1.
|
Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 2 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 1 Day 1.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Ritlecitinib
|
177.9 ng/mL
Geometric Coefficient of Variation 30
|
197.4 ng/mL
Geometric Coefficient of Variation 38
|
199.6 ng/mL
Geometric Coefficient of Variation 37
|
SECONDARY outcome
Timeframe: Post first dose of study intervention on Period 1 Day 1 up to 35 days post last dose of study intervention on Period 3 Day 1 (maximum of 40 days)Population: Includes all participants assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent AEs (TEAEs) = between first dose of study treatment and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious AE (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-related AEs and SAEs were determined by the investigator. Severe=an event that prevents normal everyday activities.
Outcome measures
| Measure |
Treatment C: Ritlecitinib 30 mg Spray Congealed Beads
n=12 Participants
Participants received a single dose of ritlecitinib 30 mg spray congealed beads on Period 3 Day 1.
|
Treatment A: Ritlecitinib 30 mg Intact Adult Capsule
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 1 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 2 Day 1.
|
Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 2 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 1 Day 1.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Participants with Severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Participants with AEs (All Causalities)
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Participants with AEs (Treatment Related)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Period 3 Day 2 (maximum of 7 days)Population: Includes all participants assigned to study intervention and who took at least 1 dose of study intervention.
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, etc), chemistry (fasting glucose, calcium, sodium, potassium, chloride, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, uric acid, total protein, albumin, etc), and urinalysis (glucose, protein, blood, ketones, nitrites, leukocyte esterase, etc). Baseline = the last pre-dose measurement before Period 1 Day 1 (ie, first dose of study intervention). Laboratory abnormalities meeting pre-defined criteria are reported for this outcome measure. ULN=upper limit of normal. LLN=lower limit of normal. HPF=high-powered field. mEq=milliequivalent. L=liter.
Outcome measures
| Measure |
Treatment C: Ritlecitinib 30 mg Spray Congealed Beads
Participants received a single dose of ritlecitinib 30 mg spray congealed beads on Period 3 Day 1.
|
Treatment A: Ritlecitinib 30 mg Intact Adult Capsule
n=12 Participants
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 1 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 2 Day 1.
|
Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 2 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 1 Day 1.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Bicarbonate (mEq/L) <0.9*LLN
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Eosinophils/Leukocytes (%) >1.2*ULN
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Monocytes/Leukocytes (%) >1.2*ULN
|
—
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Ketones (No Unit) >=1
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
URINE Hemoglobin (No Unit) >=1
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Nitrite (No Unit) >=1
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Leukocyte Esterase (No Unit) >=1
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
URINE Leukocytes (/HPF) >=20
|
—
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Bacteria (/HPF) >20
|
—
|
1 Participants
|
—
|
Adverse Events
Treatment A: Ritlecitinib 30 mg Intact Adult Capsule
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment C: Ritlecitinib 30 mg Spray Congealed Beads
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Ritlecitinib 30 mg Intact Adult Capsule
n=12 participants at risk
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 1 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 30 mg intact adult capsule on Period 2 Day 1.
|
Treatment B: Ritlecitinib 3*10 mg Pediatric Capsules
n=12 participants at risk
Participants who were assigned to Treatment sequence 1 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 2 Day 1. Participants who were assigned to Treatment sequence 2 received a single dose of ritlecitinib 3\*10 mg pediatric capsules on Period 1 Day 1.
|
Treatment C: Ritlecitinib 30 mg Spray Congealed Beads
n=12 participants at risk
Participants received a single dose of ritlecitinib 30 mg spray congealed beads on Period 3 Day 1.
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Vessel puncture site pain
|
16.7%
2/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline (ie, post the first dose of study intervention) up to 35 days post last dose of study intervention (maximum of 40 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place