A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Part of paid clinical trials in Coronado, California.

Sponsor
AbbVie
Study ID
NCT04254783
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Risankizumab — DRUG
    Intravenous (IV) infusion
  • Cytochrome P450 (CYP) Substrates — DRUG
    Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol

Study Details

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD. Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide. In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.

Key Dates

Start date
May 27, 2020
Status verified
Jun 2024
Primary completion
Oct 14, 2022
Completion
Oct 14, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cytochrome P450 (CYP) + Risankizumab
    In Period 1, participants will receive single oral dose of Cytochrome P450 (CYP) substrates on Day 1. In Period 2, three IV doses of risankizumab on Days 1, 29 and 57, followed by single oral dose of CYP substrates on Day 64 will be administered.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Midazolam [ Time Frame: Up to 71 Days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Southern California Res. Ctr. /ID# 216257CoronadoCalifornia92118-1408-
University Clinical Research /ID# 216823DeLandFlorida32720-
Atlantic Medical Research Group /ID# 227465MargateFlorida33063-5737-
Clinical Trials of Texas, Inc /ID# 216277San AntonioTexas78229-

Find similar trials in Coronado, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Southern California Res. Ctr.· Coronado, CAUniversity Clinical Research· DeLand, FLAtlantic Medical Research Group· Margate, FLClinical Trials of Texas, Inc· San Antonio, TX

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