NCT04254783

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2020

Typical duration for phase_1

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 27, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2022

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

2.4 years

First QC Date

February 3, 2020

Last Update Submit

June 28, 2024

Conditions

Ulcerative Colitis (UC)Crohn's Disease

Keywords

Ulcerative Colitis (UC)Crohn's DiseaseRisankizumabSKYRIZIABBV-066Cytochrome P450

Outcome Measures

Primary Outcomes (30)

  • Maximum Observed Plasma Concentration (Cmax) of Midazolam

    Maximum observed plasma concentration (Cmax) of Midazolam

    Up to 71 Days

  • Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam

    Time to maximum plasma concentration (Tmax) of Midazolam

    Up to 71 Days

  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

    Up to 71 Days

  • AUC From Time 0 to Infinity (AUCinf) of Midazolam

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

    Up to 71 Days

  • Terminal Phase Elimination Rate Constant (β) of Midazolam

    Terminal phase elimination rate constant (β) for Midazolam

    Up to 71 Days

  • Terminal Phase Elimination Half-Life (t1/2) of Midazolam

    Terminal phase elimination half-life (t1/2) of Midazolam

    Up to 71 Days

  • Maximum Observed Plasma Concentration (Cmax) of Caffeine

    Maximum observed plasma concentration (Cmax) of Caffeine

    Up to 71 Days

  • Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine

    Time to maximum plasma concentration (Tmax) of Caffeine

    Up to 71 Days

  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

    Up to 71 Days

  • AUC From Time 0 to Infinity (AUCinf) of Caffeine

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

    Up to 71 Days

  • Terminal Phase Elimination Rate Constant (β) of Caffeine

    Terminal phase elimination rate constant (β) for Caffeine

    Up to 71 Days

  • Terminal Phase Elimination Half-Life (t1/2) of Caffeine

    Terminal phase elimination half-life (t1/2) of Caffeine

    Up to 71 Days

  • Maximum Observed Plasma Concentration (Cmax) of Warfarin

    Maximum observed plasma concentration (Cmax) of Warfarin

    Up to 71 Days

  • Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin

    Time to maximum plasma concentration (Tmax) of Warfarin

    Up to 71 Days

  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

    Up to 71 Days

  • AUC From Time 0 to Infinity (AUCinf) of Warfarin

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

    Up to 71 Days

  • Terminal Phase Elimination Rate Constant (β) of Warfarin

    Terminal phase elimination rate constant (β) for Warfarin

    Up to 71 Days

  • Terminal Phase Elimination Half-Life (t1/2) of Warfarin

    Terminal phase elimination half-life (t1/2) of Warfarin

    Up to 71 Days

  • Maximum Observed Plasma Concentration (Cmax) of Omeprazole

    Maximum observed plasma concentration (Cmax) of Omeprazole

    Up to 71 Days

  • Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole

    Time to maximum plasma concentration (Tmax) of Omeprazole

    Up to 71 Days

  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

    Up to 71 Days

  • AUC From Time 0 to Infinity (AUCinf) of Omeprazole

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

    Up to 71 Days

  • Terminal Phase Elimination Rate Constant (β) of Omeprazole

    Terminal phase elimination rate constant (β) for Omeprazole

    Up to 71 Days

  • Terminal Phase Elimination Half-Life (t1/2) of Omeprazole

    Terminal phase elimination half-life (t1/2) of Omeprazole

    Up to 71 Days

  • Maximum Observed Plasma Concentration (Cmax) of Metoprolol

    Maximum observed plasma concentration (Cmax) of Metoprolol

    Up to 71 Days

  • Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol

    Time to maximum plasma concentration (Tmax) of Metoprolol

    Up to 71 Days

  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration

    Up to 71 Days

  • AUC From Time 0 to Infinity (AUCinf) of Metoprolol

    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

    Up to 71 Days

  • Terminal Phase Elimination Rate Constant (β) of Metoprolol

    Terminal phase elimination rate constant (β) for Metoprolol

    Up to 71 Days

  • Terminal Phase Elimination Half-Life (t1/2) of Metoprolol

    Terminal phase elimination half-life (t1/2) of Metoprolol

    Up to 71 Days

Study Arms (1)

Cytochrome P450 (CYP) + Risankizumab

EXPERIMENTAL

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.

Drug: RisankizumabDrug: Cytochrome P450 (CYP) Substrates

Interventions

RisankizumabDRUG

Intravenous (IV) infusion

Also known as: SKYRIZI, ABBV-066
Cytochrome P450 (CYP) + Risankizumab
Cytochrome P450 (CYP) SubstratesDRUG

Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol

Cytochrome P450 (CYP) + Risankizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of UC or CD for at least 3 months prior to Day -1 (baseline). Appropriate documentation of biopsy results consistent with the diagnosis of CD or UC, in the assessment of the gastroenterologist, must be available.
  • Moderately to severely active CD or UC.
  • Must have demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids, immunomodulators, and/or approved biologic therapies.
  • Participant must agree to not use any known inhibitors or inducers of cytochrome P450 within 1 month or 5 half-lives, whichever is greater before each administration of the cocktail probe and until the last pharmacokinetic sample is collected, 7 days after the intake of each probe cocktail.

You may not qualify if:

  • History of any clinically significant sensitivity or allergy to any medication or food.
  • History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption (e.g., celiac disease, gastroparesis, cholecystectomy, vagotomy).
  • Positive for COVID-19 infection signs and symptoms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Southern California Res. Ctr. /ID# 216257

Coronado, California, 92118-1408, United States

Location

University Clinical Research /ID# 216823

DeLand, Florida, 32720, United States

Location

Atlantic Medical Research Group /ID# 227465

Margate, Florida, 33063-5737, United States

Location

Clinical Trials of Texas, Inc /ID# 216277

San Antonio, Texas, 78229, United States

Location

Charite Research Organisation GmbH /ID# 218646

Berlin, 10117, Germany

Location

The Chaim Sheba Medical Center /ID# 223959

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Related Publications (1)

  • D'Cunha R, Azam T, Kalabic J, Anschutz T, Lahat A, Pang Y. Evaluation of the Effect of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease. Clin Pharmacokinet. 2025 Jan;64(1):143-154. doi: 10.1007/s40262-024-01462-4. Epub 2024 Dec 21.

    PMID: 39707077DERIVED

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeCrohn Disease

Interventions

risankizumabCytochrome P-450 Enzyme System

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CytochromesEnzymes and CoenzymesMixed Function OxygenasesOxygenasesOxidoreductasesEnzymesHemeproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

May 27, 2020

Primary Completion

October 14, 2022

Study Completion

October 14, 2022

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)DE(1)US(4)