A Phase 1 Study Evaluating Relative Bioavailability of Sprinkled Ritlecitinib in Applesauce, Yoghurt, and Strawberry Jam and Evaluating the Effect of Food on the Bioavailability of Ritlecitinib Intact Blend-In Capsule in Healthy Adult Participants.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

28 Apr 2023 → 25 Jul 2023

Decision date (initial)

2023-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Pharmacokinetic

To estimate the relative BA of ritlecitinib intact BiC (Blend in Capsule) when sprinkled on food (apple sauce, strawberry jam, and yoghurt) compared to intact BiC (reference) at a 30 mg dose under fasted conditions in adult healthy participants and to estimate the effect of food on the relative BA of ritlecitinib intact BiC at a 30 mg dose.

Secondary objectives 1

1. To evaluate the safety and tolerability of 30 mg BiCs of ritlecitinib administered to healthy adult participants under fasted and fed conditions.

Conditions and MedDRA coding

Alopecia Areata, Rheumatoid Arthritis, Vitiligo, Ulcerative Colitis and Crohn's Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants aged 18 or older (or the minimal age of consent in accordance with location regulations) at screening.
2. Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, full physical examination (which includes BP and pulse rate measurement), clinical laboratory tests, and 12-lead ECG
3. BMI of 16 to 32 kg/m2, and a total body weight >45 kg (99 lb).
4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
5. Capable of giving signed informed consent.

Exclusion criteria 9

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
3. Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency.
4. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm history.
5. Participants with any of the specified acute or chronic infections or infection history.
6. History of febrile illness within 5 days prior to the first dose of study intervention.
7. History of any lymphoproliferative disorder such as EBV related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs or symptoms suggestive of current lymphatic or lymphoid disease.
8. 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.
9. Evidence of untreated or inadequately treated active or latent Mycobacterium TB infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Plasma AUCinf and Cmax of ritlecitinib

Secondary endpoints 1

1. AE monitoring

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

235 East 42nd Street

City

New York

Postcode

10017-5703

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications