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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Scintipharma - Lexington - Maywick View Lane

Lexington, Kentucky, 40504, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Capable of giving signed informed consent

Exclusion criteria

  • 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).
  • Participants with the acute or chronic infections or infection history
  • History of febrile illness within 5 days prior to the first dose of study intervention.
  • 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.
  • 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.
  • 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.
  • 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.
  • Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose.

Treatment and study plan

Ritlecitinib

Drug

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

Other names: PF-06651600

Primary outcomes

  1. Site of capsule disintegration and MR microsphere dispersion

    Time frame: 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.

  2. Gastric emptying time

    Time frame: 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%.

  3. Small intestine residence/transit time

    Time frame: 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.

  4. Colon arrival time

    Time frame: 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%.

  5. Colon (ascending, transverse, descending) residence/transit time

    Time frame: 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.

  6. Total transit time

    Time frame: 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 outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 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)

  2. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)

    Time frame: 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.

  3. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)

    Time frame: 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)

  4. Time for Cmax (Tmax)

    Time frame: 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)

  5. Terminal half-life (t1/2)

    Time frame: 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.

  6. Frequency of adverse events

    Time frame: 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.

  7. Frequency of abnormal clinical laboratory tests

    Time frame: 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.

  8. Frequency of abnormal vital signs

    Time frame: 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.

  9. Frequency of abnormal 12-lead ECG

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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