Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

Withdrawn before enrolling · Phase 4

Conditions studied: Colitis, Ulcerative, Crohn Disease

In brief

The purpose of this study is to evaluate in a step-wise approach the disease drug-drug interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome P-450 (CYP) substrate drugs by modulating pro-inflammatory cytokines in participants with ulcerative colitis (UC) or Crohn's disease (CD) who are treated with vedolizumab.

Key facts

Study ID: NCT02760615
Run by: Takeda
People needed: 0
Starts: 2016-11-01
Expected to finish: 2020-08-01
Last updated by the study team: 2020-10-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
Is a cytochrome P-450 (CYP)2C9, CYP2C19, and CYP2D6 extensive metabolizer, based on genotyping of pharmacogenomic (PGx) deoxyribonucleic acid (DNA) analysis.
Is a male or female aged 18 to 55 years, inclusive, at Screening.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m\^2), inclusive, at Screening and Check-in (Day -1).
The healthy control participants in Part 1 of this study will be matched at Day-1 with the UC or CD participants in Group 1 or 3 (whichever enrolls faster) on the basis of age (+/-10 years), gender and weight (+/-30 [percent] %).
Participants in Part 2 and Group 1 will be matched on Day-1 on the basis of the inflammatory bowel disease (IBD) diagnosis (UC or CD), age (+/-10 years), gender and weight (+/-30%).
For Part 1 Participants:
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study.
All female participants who are of childbearing potential and who are sexually active, agree to routinely use adequate contraception from signing of informed consent throughout the duration of the study. NOTE: Female participants NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation [at least 2 years post-operation]) or who are postmenopausal (example, defined as at least 1 year since last regular menses with an follicle stimulated hormone [FSH] greater than [>] 40 international units per liter [IU/L] or at least 5 years since last regular menses, confirmed before any study medication is implemented).
For Part 1 Only Participants with UC or CD
Has a diagnosis of UC or CD established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
Prior to entering the study, participants with UC must have had an endoscopy during screening to confirm active disease, with Mayo score of 6 to 12 and an endoscopic subscore greater than or equal to (>=)2. Participants with CD must have a Crohn's Disease Activity Index (CDAI) score of 220 to 450 to confirm moderate to severe disease on entry (that is, Day-1).
Participant may be receiving a therapeutic dose of the following drugs for treatment of their underlying disease:
Oral or topical 5-aminosalicylic acid (5-ASA) compounds provided that the dose has been stable for the 2 weeks immediately prior to enrollment.
Probiotics (example, Culturelle, Saccharomyces boulardii) provided that the dose has been stable for the 2 weeks immediately prior to enrollment.
Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
Azathioprine or 6-mercaptopurine, provided that the dose has been stable for the 8 weeks immediately prior to enrollment.
Methotrexate provided that the dose has been stable for the 8 weeks immediately prior to randomization.
Oral corticosteroid therapy (prednisone at a stable dose less than or equal to [<=] 30 milligram per day [mg/day], or equivalent steroid) provided that the dose has been stable for the 4 weeks immediately prior to enrollment, if corticosteroids have been initiated, or for the 2 weeks immediately prior to the enrollment, if corticosteroids are being tapered.
C-reactive protein (CRP) >=5 milligram per liter (mg/L) during screening period in participants with CD.
For Part 1 Healthy Participants Only:
The participant, in opinion of the investigator, is in healthy condition as determined by a prestudy physical examination, medical history, vital signs, electrocardiogram (ECG), and the results of blood biochemistry, hematology, serology, and urinalysis tests.
For Part 2 Participants with Active UC and CD:
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 57 days after last dose.

You may not qualify if…

For both Part 1 and Part 2:
Has a known hypersensitivity to any of the drugs or components in the Injection (Inje) Cocktail.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
Within 30 days prior to enrollment, participants with UC or CD have received any treatment of underlying disease other than those specifically listed in the protocol for the Treatment of UC or CD.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 57 days after participating in this study; or intending to donate ova during such time period.
If male, the participant intends to donate sperm during the course of this study or for 57 days thereafter.
Has received rituximab or natalizumab treatment or other integrin inhibitors.
Has taken any excluded medication, supplements, or food products listed in the protocol.
Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
Has had extensive colonic resection, subtotal or total colectomy.
Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Has evidence of or has had treatment for Clostridium difficile infection within 60 days or other intestinal pathogen within 30 days prior to enrollment.
Has a history or evidence of adenomatous colonic polyps that have not been removed.
Has a history or evidence of colonic mucosal dysplasia.
Has chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Has any identified congenital or acquired immunodeficiency (example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
Has received any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine.
Has clinically significant infection (example, pneumonia, pyelonephritis) within 30 days prior to enrollment.
Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
Has had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period.
Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to enrollment. Participants with remote history of malignancy (example, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
Has a current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
Has active psychiatric problems that, in the investigator's opinion, may interfere with compliance with the study procedures.
Is unable to attend all the study visits or comply with study procedures.
For Part 1 Participants With UC or CD:

Where it is running

WCCT — Cypress, California, United States
QPS MRA — Miami, Florida, United States

Full record on ClinicalTrials.gov

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