A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food

Healthy Volunteers Clinical Trial

Official title:

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-SEQUENCE, 3-PERIOD STUDY TO CHARACTERIZE THE GASTROINTESTINAL TRANSIT OF A MODIFIED-RELEASE CAPSULE FORMULATION UNDER FASTED AND FED CONDITIONS BY SINGLE LABEL GAMMA SCINTIGRAPHY IN HEALTHY MALE ADULT PARTICIPANTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369454
• Other study ID #: B7981090
• Status: Recruiting
• Phase: Phase 1
• Start date: May 3, 2024
• Est. completion date: August 2, 2024

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.

This study is seeking healthy participants who have:

• Aged 18 years or older;

• male who are healthy as determined by medical assessment;

• BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb).

All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).

The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

2. BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb).

3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

4. Capable of giving signed informed consent

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

2. Participants with the acute or chronic infections or infection history

3. History of febrile illness within 5 days prior to the first dose of study intervention.

4. 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.

5. 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.

6. History of active or latent Mycobacterium TBA: participant who is currently being treated for active or latent Mycobacterium TB infection or has a history of Mycobacterium TB must be excluded from the study.

7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

8. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Ritlecitinib
Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg) with 153Sm2O3

Locations

Country	Name	City	State
United States	Scintipharma - Lexington - Maywick View Lane	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Site of capsule disintegration and MR microsphere dispersion	The time and gastrointestinal location where the HPMC capsule(s) disintegrate and disperse the drug formulation.	up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Primary	Gastric emptying time	Gastric emptying metrics may include a) time of 1st GE; b) time(s) for GE 10%, 25%, 50%, 75%, 90% and complete gastric emptying time GE100%.	up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Primary	Small intestine residence/transit time	Small Intestine transit metrics may include time for 10%, 25%, 50%, 75%, 90% and 100% of the formulation to transit through the small intestine.	up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Primary	Colon arrival time	Arrival time at the colon (ATC) metrics may include a) time(s) for ATC 10%, 25%, 50%, 75%, 90% and 100%.	up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Primary	Colon (ascending, transverse, descending) residence/transit time	The residence time of the formulation in the three primary regions of the large intestine to include the ascending, transverse and descending colon.	up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Primary	Total transit time	Residence time of the formulation in the gastrointestinal tract.	up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
Secondary	Maximum plasma concentration (Cmax)	Maximum plasma concentration (Cmax)	Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Secondary	Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)	Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) will be calculated if data permit.	Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Secondary	Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)	Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)	Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Secondary	Time for Cmax (Tmax)	Time for Cmax (Tmax)	Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Secondary	Terminal half-life (t1/2)	Terminal half-life (t1/2) will be calculated if data permit.	Solution: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. Capsules: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Secondary	Frequency of adverse events	To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.	Baseline up to Day 35
Secondary	Frequency of abnormal clinical laboratory tests	To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.	Baseline up to Day 11
Secondary	Frequency of abnormal vital signs	To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.	Baseline up to Day 11
Secondary	Frequency of abnormal 12-lead ECG	To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants.	Baseline up to Day 11

External Links

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