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Completed

NCT Number: NCT04254783

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

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charite Research Organisation GmbH /ID# 218646, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risankizumab

Drug

Intravenous (IV) infusion

Other names: SKYRIZI, ABBV-066

Cytochrome P450 (CYP) Substrates

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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