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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04254783
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Crohn's Disease Drug: Risankizumab Drug: Cytochrome P450 (CYP) Substrates Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Actual Study Start Date : February 16, 2020
Estimated Primary Completion Date : November 5, 2021
Estimated Study Completion Date : November 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Risankizumab
Intravenous (IV) infusion
Other Names:
  • SKYRIZI
  • ABBV-066

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




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Midazolam [ Time Frame: Up to 71 Days ]
    Maximum observed plasma concentration (Cmax) of Midazolam

  2. Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam [ Time Frame: Up to 71 Days ]
    Time to maximum plasma concentration (Tmax) of Midazolam

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

  4. AUC From Time 0 to Infinity (AUCinf) of Midazolam [ Time Frame: Up to 71 Days ]
    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

  5. Terminal Phase Elimination Rate Constant (β) of Midazolam [ Time Frame: Up to 71 Days ]
    Terminal phase elimination rate constant (β) for Midazolam

  6. Terminal Phase Elimination Half-Life (t1/2) of Midazolam [ Time Frame: Up to 71 Days ]
    Terminal phase elimination half-life (t1/2) of Midazolam

  7. Maximum Observed Plasma Concentration (Cmax) of Caffeine [ Time Frame: Up to 71 Days ]
    Maximum observed plasma concentration (Cmax) of Caffeine

  8. Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine [ Time Frame: Up to 71 Days ]
    Time to maximum plasma concentration (Tmax) of Caffeine

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

  10. AUC From Time 0 to Infinity (AUCinf) of Caffeine [ Time Frame: Up to 71 Days ]
    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

  11. Terminal Phase Elimination Rate Constant (β) of Caffeine [ Time Frame: Up to 71 Days ]
    Terminal phase elimination rate constant (β) for Caffeine

  12. Terminal Phase Elimination Half-Life (t1/2) of Caffeine [ Time Frame: Up to 71 Days ]
    Terminal phase elimination half-life (t1/2) of Caffeine

  13. Maximum Observed Plasma Concentration (Cmax) of Warfarin [ Time Frame: Up to 71 Days ]
    Maximum observed plasma concentration (Cmax) of Warfarin

  14. Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin [ Time Frame: Up to 71 Days ]
    Time to maximum plasma concentration (Tmax) of Warfarin

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

  16. AUC From Time 0 to Infinity (AUCinf) of Warfarin [ Time Frame: Up to 71 Days ]
    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

  17. Terminal Phase Elimination Rate Constant (β) of Warfarin [ Time Frame: Up to 71 Days ]
    Terminal phase elimination rate constant (β) for Warfarin

  18. Terminal Phase Elimination Half-Life (t1/2) of Warfarin [ Time Frame: Up to 71 Days ]
    Terminal phase elimination half-life (t1/2) of Warfarin

  19. Maximum Observed Plasma Concentration (Cmax) of Omeprazole [ Time Frame: Up to 71 Days ]
    Maximum observed plasma concentration (Cmax) of Omeprazole

  20. Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole [ Time Frame: Up to 71 Days ]
    Time to maximum plasma concentration (Tmax) of Omeprazole

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

  22. AUC From Time 0 to Infinity (AUCinf) of Omeprazole [ Time Frame: Up to 71 Days ]
    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

  23. Terminal Phase Elimination Rate Constant (β) of Omeprazole [ Time Frame: Up to 71 Days ]
    Terminal phase elimination rate constant (β) for Omeprazole

  24. Terminal Phase Elimination Half-Life (t1/2) of Omeprazole [ Time Frame: Up to 71 Days ]
    Terminal phase elimination half-life (t1/2) of Omeprazole

  25. Maximum Observed Plasma Concentration (Cmax) of Metoprolol [ Time Frame: Up to 71 Days ]
    Maximum observed plasma concentration (Cmax) of Metoprolol

  26. Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol [ Time Frame: Up to 71 Days ]
    Time to maximum plasma concentration (Tmax) of Metoprolol

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

  28. AUC From Time 0 to Infinity (AUCinf) of Metoprolol [ Time Frame: Up to 71 Days ]
    Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity

  29. Terminal Phase Elimination Rate Constant (β) of Metoprolol [ Time Frame: Up to 71 Days ]
    Terminal phase elimination rate constant (β) for Metoprolol

  30. Terminal Phase Elimination Half-Life (t1/2) of Metoprolol [ Time Frame: Up to 71 Days ]
    Terminal phase elimination half-life (t1/2) of Metoprolol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254783


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
Southern California Res. Ctr. /ID# 216257 Recruiting
Coronado, California, United States, 92118-1408
United States, Florida
University Clinical Research /ID# 216823 Recruiting
DeLand, Florida, United States, 32720
United States, Texas
Clinical Trials of Texas,Inc. /ID# 216277 Recruiting
San Antonio, Texas, United States, 78229
Germany
Charite Research Organisation GmbH /ID# 218646 Not yet recruiting
Berlin, Germany, 10117
Israel
Sheba Medical Center /ID# 223959 Not yet recruiting
Ramat Gan, Israel, 5239424
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04254783    
Other Study ID Numbers: M19-974
2019-003684-22 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Ulcerative Colitis (UC)
Crohn's Disease
Risankizumab
SKYRIZI
ABBV-066
Cytochrome P450
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes