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Phase 1 Completed N=12 Basic Science

Study to Evaluate the Effect of Multiple-Dose Ritlecitinib on the Pharmacokinetics (PK) of Tolbutamide

Healthy Volunteers
Source: ClinicalTrials.gov NCT05097716 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Tolbutamide Administered With and Without Ritlecitinib — 44240; 45740 ng/mL (nanogram/milliliter)

Summary

This is a Phase 1, 2-period, multiple-dose, open-label, single fixed sequence study of the effect of ritlecitinib on tolbutamide pharmacokinetics in healthy participants.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Plasma Concentration (Cmax) of Tolbutamide Administered With and Without Ritlecitinib
44240; 45740
PRIMARY
Area Under the Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Tolbutamide Administered With and Without Ritlecitinib
608600; 586500
SECONDARY
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - All Causalities and Treatment Related
1; 2; 2; 0; 0; 1

Eligibility Criteria

Inclusion Criteria

  • Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination (including BP and pulse rate measurements), clinical laboratory tests, and 12-lead ECG.
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

  • Past/present clinically significant hematological, renal, endocrine, pulmonary, GI, CV, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • Infection with hepatitis B or C viruses.
  • Participants with any of the following acute or chronic infections or infection history: any infection requiring treatment within 2 weeks prior to the start of study participation; any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of investigational product; any infection judged to be an opportunistic infection or clinically significant within the past 6 months of the first dose of investigational product; known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections; history of recurrent localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
  • 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 presence or a history of malignancy other than a successfully treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05097716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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