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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04254783
Other study ID # M19-974
Secondary ID 2019-003684-22
Status Completed
Phase Phase 1
First received
Last updated
Start date May 27, 2020
Est. completion date October 14, 2022

Study information

Verified date October 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 14, 2022
Est. primary completion date October 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

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

Locations

Country Name City State
Germany Charite Research Organisation GmbH /ID# 218646 Berlin
Israel The Chaim Sheba Medical Center /ID# 223959 Ramat Gan Tel-Aviv
United States Southern California Res. Ctr. /ID# 216257 Coronado California
United States University Clinical Research /ID# 216823 DeLand Florida
United States Atlantic Medical Research Group /ID# 227465 Margate Florida
United States Clinical Trials of Texas, Inc /ID# 216277 San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Germany,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Observed Plasma Concentration (Cmax) of Midazolam Maximum observed plasma concentration (Cmax) of Midazolam Up to 71 Days
Primary Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam Time to maximum plasma concentration (Tmax) of Midazolam Up to 71 Days
Primary 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
Primary 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
Primary Terminal Phase Elimination Rate Constant (ß) of Midazolam Terminal phase elimination rate constant (ß) for Midazolam Up to 71 Days
Primary Terminal Phase Elimination Half-Life (t1/2) of Midazolam Terminal phase elimination half-life (t1/2) of Midazolam Up to 71 Days
Primary Maximum Observed Plasma Concentration (Cmax) of Caffeine Maximum observed plasma concentration (Cmax) of Caffeine Up to 71 Days
Primary Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine Time to maximum plasma concentration (Tmax) of Caffeine Up to 71 Days
Primary 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
Primary 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
Primary Terminal Phase Elimination Rate Constant (ß) of Caffeine Terminal phase elimination rate constant (ß) for Caffeine Up to 71 Days
Primary Terminal Phase Elimination Half-Life (t1/2) of Caffeine Terminal phase elimination half-life (t1/2) of Caffeine Up to 71 Days
Primary Maximum Observed Plasma Concentration (Cmax) of Warfarin Maximum observed plasma concentration (Cmax) of Warfarin Up to 71 Days
Primary Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin Time to maximum plasma concentration (Tmax) of Warfarin Up to 71 Days
Primary 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
Primary 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
Primary Terminal Phase Elimination Rate Constant (ß) of Warfarin Terminal phase elimination rate constant (ß) for Warfarin Up to 71 Days
Primary Terminal Phase Elimination Half-Life (t1/2) of Warfarin Terminal phase elimination half-life (t1/2) of Warfarin Up to 71 Days
Primary Maximum Observed Plasma Concentration (Cmax) of Omeprazole Maximum observed plasma concentration (Cmax) of Omeprazole Up to 71 Days
Primary Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole Time to maximum plasma concentration (Tmax) of Omeprazole Up to 71 Days
Primary 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
Primary 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
Primary Terminal Phase Elimination Rate Constant (ß) of Omeprazole Terminal phase elimination rate constant (ß) for Omeprazole Up to 71 Days
Primary Terminal Phase Elimination Half-Life (t1/2) of Omeprazole Terminal phase elimination half-life (t1/2) of Omeprazole Up to 71 Days
Primary Maximum Observed Plasma Concentration (Cmax) of Metoprolol Maximum observed plasma concentration (Cmax) of Metoprolol Up to 71 Days
Primary Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol Time to maximum plasma concentration (Tmax) of Metoprolol Up to 71 Days
Primary 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
Primary 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
Primary Terminal Phase Elimination Rate Constant (ß) of Metoprolol Terminal phase elimination rate constant (ß) for Metoprolol Up to 71 Days
Primary Terminal Phase Elimination Half-Life (t1/2) of Metoprolol Terminal phase elimination half-life (t1/2) of Metoprolol Up to 71 Days
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