Healthy Volunteers
Conditions
Keywords
Pharmacokinetics,, Scintigraphy,, Adults
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.
Interventions
DRUGRitlecitinib
Ritlecitinib 100 milligrams (mg) will be provided as either solution or capsule formulation (2 capsules of 50 mg) with 153Sm2O3
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Site of capsule disintegration and MR microsphere dispersion | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) | The time and gastrointestinal location where the HPMC capsule(s) disintegrate and disperse the drug formulation. |
| Gastric emptying time | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) | 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%. |
| Small intestine residence/transit time | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) | Small Intestine transit metrics may include time for 10%, 25%, 50%, 75%, 90% and 100% of the formulation to transit through the small intestine. |
| Colon arrival time | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) | Arrival time at the colon (ATC) metrics may include a) time(s) for ATC 10%, 25%, 50%, 75%, 90% and 100%. |
| Colon (ascending, transverse, descending) residence/transit time | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) | The residence time of the formulation in the three primary regions of the large intestine to include the ascending, transverse and descending colon. |
| Total transit time | up to 48 hours post dose or as long as radioactivity is present in the GI tract (if it is shorter than 48 hours) | Residence time of the formulation in the gastrointestinal tract. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of abnormal clinical laboratory tests | Baseline up to Day 11 | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. |
| Frequency of adverse events | Baseline up to Day 35 | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. |
| Frequency of abnormal 12-lead ECG | Baseline up to Day 11 | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. |
| Frequency of abnormal vital signs | Baseline up to Day 11 | To evaluate safety and tolerability of ritlecitinib following single oral administration as solution and MR capsule formulations in healthy male adult participants. |
| 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. | Maximum plasma concentration (Cmax) |
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) | 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. | Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) will be calculated if data permit. |
| 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. | Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) |
| 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. | Time for Cmax (Tmax) |
| Terminal half-life (t1/2) | 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. | Terminal half-life (t1/2) will be calculated if data permit. |
Countries
United States
Outcome results
None listed