A Study to Learn How Different Manufactured Products of the Study Medicine Called Ritlecitinib are Taken up Into the Blood in Healthy Adults When Taken on an Empty Stomach or When Taken With a Meal in Healthy Adults.

Start 29 Jan 2024 · End 29 Mar 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol B7981086

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 12

Countries 1

Sites 1

ulcerative colitis, Crohn’s Disease, alopecia areata, rheumatoid arthritis, vitiligo

Key facts

Sponsor: Pfizer Inc.
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trial duration: 29 Jan 2024 → 29 Mar 2024
Decision date (initial): 2023-10-25
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

ulcerative colitis, Crohn’s Disease, alopecia areata, rheumatoid arthritis, vitiligo

Version	Level	Code	Term	System organ class
20.0	PT	10001761	Alopecia areata	100000004858
20.0	LLT	10013099	Disease Crohns	10017947
20.0	PT	10009900	Colitis ulcerative	100000004856
21.1	PT	10047642	Vitiligo	100000004858
21.0	PT	10039073	Rheumatoid arthritis	100000004859

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation: Pfizer Inc.
Address: 66 Hudson Boulevard East
City: New York
Postcode: 10001-2189
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

Country	MS status	Planned subjects	Sites
Belgium	Ended	12	1
Rest of world	—	0	—

Investigational sites

Belgium

1 site · Ended

Pfizer Clinical Research Unit

N/A, Lennikse Baan 808, 1070, Brussels

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Belgium	2024-01-29	2024-03-28	2024-02-01	2024-02-13

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-09-20	Belgium	Acceptable with conditions 2023-10-25	2023-10-25
2	SUBSTANTIAL MODIFICATION	SM-1	2023-12-06	Belgium	Acceptable 2024-01-15	2024-01-26
3	SUBSTANTIAL MODIFICATION	SM-2	2024-02-23	Belgium	Acceptable 2024-03-25	2024-03-25