A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2021-11-19

Brief Summary

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A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate for approximately 2.5 months.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment sequence 1

Treatment sequence 1 will receive a single 30 milligrams (mg) ritlecitinib intact adult capsule during the first period, three 10 mg ritlecitinib pediatric capsules during the second period and 30 mg ritlecitinib spray congealed beads in the third period.

Group Type EXPERIMENTAL

ritlecitinib

Intervention Type DRUG

30 mg intact adult capsule

ritlecitinib

Intervention Type DRUG

10 mg pediatric capsule

ritlecitinib

Intervention Type DRUG

30 mg spray congealed beads

Treatment Sequence 2

Treatment sequence 2 will receive three 10 mg ritlecitinib pediatric capsules during the first period, a single 30 mg intact adult capsule during the second period and 30 mg ritlecitinib spray congealed beads in the third period.

Group Type EXPERIMENTAL

ritlecitinib

Intervention Type DRUG

30 mg intact adult capsule

ritlecitinib

Intervention Type DRUG

10 mg pediatric capsule

ritlecitinib

Intervention Type DRUG

30 mg spray congealed beads

Interventions

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ritlecitinib

30 mg intact adult capsule

Intervention Type DRUG

ritlecitinib

10 mg pediatric capsule

Intervention Type DRUG

ritlecitinib

30 mg spray congealed beads

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete (full) physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Known immunodeficiency disorder, including positive serology for HIV at screening, or a first degree relative with a hereditary immunodeficiency
* Infection with hepatitis B or hepatitis C viruses.
* History of any lymphoproliferative disorder
* Known present or a history of malignancy other than a successfully treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes