A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

Part of paid clinical trials in Cypress, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03358706
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Ustekinumab IV Infusion — DRUG
    Participants will receive a single IV infusion dose of ustekinumab (dosage to be decided based on body weight) on Day 8.
  • Ustekinumab SC Injection — DRUG
    Participants will receive a Ustekinumab 90 mg SC maintenance dose on Day 64. A second optional maintenance dose may be administered on Day 120 based on participants clinical response assessed by investigator.
  • Midazolam 2 mg — DRUG
    Participants will receive 2 milligram per milliliter (mg/ml) syrup of midazolam as a component of the Cytochrome P 450 probe cocktail orally.
  • Warfarin 10 mg — DRUG
    Participants will receive 10 mg tablet of warfarin as a component of the Cytochrome P 450 probe cocktail orally.
  • Vitamin K 10 mg — DRUG
    Participants will receive 10 mg tablet of vitamin K as a component of the Cytochrome P 450 probe cocktail orally.
  • Omeprazole 20 mg — DRUG
    Participants will receive 20 mg capsule of omeprazole as a component of the Cytochrome P 450 probe cocktail orally.
  • Dextromethorphan 30 mg — DRUG
    Participants will receive 30 mg capsule of dextromethorphan as a component of the Cytochrome P 450 probe cocktail orally.
  • Caffeine 100 mg — DRUG
    Participants will receive 100 mg tablet of caffeine as a component of the Cytochrome P 450 probe cocktail orally.

Study Details

The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe substrates of cytochrome P450 (CYP) enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) in participants with Active Crohn's disease (CD) or Ulcerative Colitis (UC).

Key Dates

Start date
Feb 2, 2018
Status verified
Aug 2025
Primary completion
Nov 22, 2021
Completion
Nov 22, 2021

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Crohn's Disease or Ulcerative Colitis Participants: Ustekinumab + Probe Cocktail
    Participants will receive a single Intravenous (IV) infusion dose of ustekinumab (dosage to be decided based on body weight) on Day 8 and a ustekinumab 90 milligram (mg) maintenance dose via subcutaneous (SC) route on Day 64. A second optional maintenance dose may be administered on Day 120 based on participants clinical response assessed by investigator. The probe cocktail (2 milligram \[mg\] of midazolam, 10 mg of warfarin plus 10 mg of vitamin K, 20 mg of omeprazole, 30 mg dextromethorphan, and 100 mg of caffeine) will be administered orally on Days 1, 22, and 113.
  • Experimental: Healthy Participants: Probe Cocktail
    Participants will receive the probe cocktail (2 mg of midazolam, 10 mg of warfarin plus 10 mg of vitamin K, 20 mg of omeprazole, 30 mg dextromethorphan, and 100 mg of caffeine) orally on Day 1.

Primary Outcome Measure

For Crohn's disease (CD) or Ulcerative Colitis (UC) Participants: Geometric Mean Ratio (Day 22/ Day 1) of the Maximum Plasma Concentration (Cmax) of Cytochrome P450 Probe Substrates (Midazolam, Omeprazole, Dextromethorphan, S-warfarin and Caffeine) [ Time Frame: Day 1 and 22: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post dose ]

Locations (3)

FacilityCityStateZIPSite coordinators
WCCT Global, LLCCypressCalifornia90630-
Ocean Blue Medical Research Center Inc.Miami SpringsFlorida33166-
Duke UniversityDurhamNorth Carolina27710-

Find similar trials in Cypress, CA

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
WCCT Global, LLC· Cypress, CAOcean Blue Medical Research Center Inc.· Miami Springs, FLDuke University· Durham, NC

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