Clinical trial NCT06369454: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics,
Scintigraphy,
Adults
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Site of capsule disintegration and MR microsphere dispersion
timeFrame: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
measure: Gastric emptying time
timeFrame: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
measure: Small intestine residence/transit time
timeFrame: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
measure: Colon arrival time
timeFrame: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
measure: Colon (ascending, transverse, descending) residence/transit time
timeFrame: up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours)
measure: Total transit time
timeFrame: 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 outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 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.
measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
timeFrame: 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.
measure: Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
timeFrame: 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.
measure: Time for Cmax (Tmax)
timeFrame: 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.
measure: Terminal half-life (t1/2)
timeFrame: 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.
measure: Frequency of adverse events
timeFrame: Baseline up to Day 35
measure: Frequency of abnormal clinical laboratory tests
timeFrame: Baseline up to Day 11
measure: Frequency of abnormal vital signs
timeFrame: Baseline up to Day 11
measure: Frequency of abnormal 12-lead ECG
timeFrame: Baseline up to Day 11
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Scintipharma - Lexington - Maywick View Lane
state: Kentucky
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: