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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous (IV) infusion
Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol
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, United States
Charite Research Organisation GmbH /ID# 218646
Berlin, Germany
The Chaim Sheba Medical Center /ID# 223959
Ramat Gan, Tel Aviv, Israel
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Maximum observed plasma concentration (Cmax) of Midazolam
Time frame: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam
Time to maximum plasma concentration (Tmax) of Midazolam
Time frame: 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
Time frame: 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
Time frame: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Midazolam
Terminal phase elimination rate constant (β) for Midazolam
Time frame: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Midazolam
Terminal phase elimination half-life (t1/2) of Midazolam
Time frame: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Caffeine
Maximum observed plasma concentration (Cmax) of Caffeine
Time frame: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine
Time to maximum plasma concentration (Tmax) of Caffeine
Time frame: 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
Time frame: 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
Time frame: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Caffeine
Terminal phase elimination rate constant (β) for Caffeine
Time frame: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Caffeine
Terminal phase elimination half-life (t1/2) of Caffeine
Time frame: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Warfarin
Maximum observed plasma concentration (Cmax) of Warfarin
Time frame: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin
Time to maximum plasma concentration (Tmax) of Warfarin
Time frame: 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
Time frame: 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
Time frame: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Warfarin
Terminal phase elimination rate constant (β) for Warfarin
Time frame: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Warfarin
Terminal phase elimination half-life (t1/2) of Warfarin
Time frame: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Omeprazole
Maximum observed plasma concentration (Cmax) of Omeprazole
Time frame: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole
Time to maximum plasma concentration (Tmax) of Omeprazole
Time frame: 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
Time frame: 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
Time frame: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Omeprazole
Terminal phase elimination rate constant (β) for Omeprazole
Time frame: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Omeprazole
Terminal phase elimination half-life (t1/2) of Omeprazole
Time frame: Up to 71 Days
Maximum Observed Plasma Concentration (Cmax) of Metoprolol
Maximum observed plasma concentration (Cmax) of Metoprolol
Time frame: Up to 71 Days
Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol
Time to maximum plasma concentration (Tmax) of Metoprolol
Time frame: 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
Time frame: 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
Time frame: Up to 71 Days
Terminal Phase Elimination Rate Constant (β) of Metoprolol
Terminal phase elimination rate constant (β) for Metoprolol
Time frame: Up to 71 Days
Terminal Phase Elimination Half-Life (t1/2) of Metoprolol
Terminal phase elimination half-life (t1/2) of Metoprolol
Time frame: Up to 71 Days
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