This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis

NCT02772601 | Completed Phase 1

• 3 other identifiers: M16-0072015-005523-311311.36
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a means of predicting drug-drug interactions.

Conditions

Psoriasis

Keywords

ABBV-066; BI 655066; risankizumab

Outcome Measures

Primary Outcomes (20)

• AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 98-101

• AUC0 - tz (area under the concentration-time curve) of caffeine without risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 1-3

• AUC0 - tz (area under the concentration-time curve) of warfarin with risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 98 - 105

• AUC0 - tz (area under the concentration-time curve) of warfarin without risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 1-8

• AUC0 - tz (area under the concentration-time curve) of omeprazole with risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 98 - 100

• AUC0 - tz (area under the concentration-time curve) of omeprazole without risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 1-2

• AUC0 - tz (area under the concentration-time curve) of metoprolol with risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 98 -100

• AUC0 - tz (area under the concentration-time curve) of metoprolol without risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 1-3

• AUC0 - tz (area under the concentration-time curve) of midazolam with risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 98 - 99

• AUC0 - tz (area under the concentration-time curve) of midazolam without risankizumab in plasma over time interval from 0 to last quantifiable data point

  Day 1-2

• Cmax (maximum measured concentration) of the analyte omeprazole without risankizumab in plasma

  Day 1

• Cmax (maximum measured concentration) of the analyte metoprolol with risankizumab in plasma

  Day 98

• Cmax (maximum measured concentration) of the analyte metoprolol without risankizumab in plasma

  Day 1

• Cmax (maximum measured concentration) of the analyte midazolam with risankizumab in plasma

  Day 98

• Cmax (maximum measured concentration) of the analyte midazolam without risankizumab in plasma

  Day 1

• Cmax (maximum measured concentration) of the analyte caffeine with risankizumab in plasma

  Day 98

• Cmax (maximum measured concentration) of the analyte caffeine without risankizumab in plasma

  Day 1

• Cmax (maximum measured concentration) of the analyte warfarin with risankizumab in plasma

  Day 98

• Cmax (maximum measured concentration) of the analyte warfarin without risankizumab in plasma

  Day 1

• Cmax (maximum measured concentration) of the analyte omeprazole with risankizumab in plasma

  Day 98

Study Arms (1)

All patients

EXPERIMENTAL

Drug: Caffeine; Drug: Warfarin; Drug: Omeprazole; Drug: Metoprolol; Drug: Midazolam; Drug: Risankizumab

Interventions

Caffeine DRUG

All patients

Warfarin DRUG

All patients

Omeprazole DRUG

All patients

Metoprolol DRUG

All patients

Midazolam DRUG

All patients

Risankizumab DRUG

Also known as: ABBV-066, BI 655066

All patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent in accordance with GCP (Good Clinical Practice) and local legislation prior to admission to the trial and prior to any trial related procedure.
• Age 18 years to 75 years at screening
• Body mass index of 18.5 to 40.0 kg/m2 and within the weight range of 50 to 148 kg
• Male or female patients.
• If female, subject must be either postmenopausal, defined as:
• Age \> 55 years with no menses for 12 or more months without an alternative medical cause.
• Age \< 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level \> 40 IU/L.
• Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
• Females must have negative results for pregnancy tests performed:
• at Screening on a urine sample obtained within 30 days prior to initial study drug administration, and
• prior to initial dosing on a serum sample obtained at the start of confinement
• Women of Childbearing Potential (WOCBP) must practice at least one of the following methods of birth control, on Study Day 1 (or earlier) through at least 140 days after the last dose of study drug.
• Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with the inhibition of ovulation, initiated at least 1 month prior to Study Day 1.
• Progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, initiated at least 1 month prior to Study Day 1.
• Bilateral tubal occlusion/ligation.

You may not qualify if:

• Patients with
• non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
• current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• active ongoing inflammatory diseases other than psoriasis that might confound trial evaluations according to investigator's judgment
• Participation in another trial with an investigational drug or device within 4 weeks or 5 half-lives (whichever is greater) prior to screening. Observational study is permitted.
• Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
• Major surgery performed within 12 weeks prior to screening or planned within 10 months after screening (e.g. hip replacement, aneurysma removal, stomach ligation)
• Active systemic infections during the last 2 weeks (exception: common cold) prior to screening
• Chronic or relevant acute infections including HIV (Human Immunodeficiency Virus), viral hepatitis and (or) tuberculosis or evidence of tuberculosis infection as defined by a positive QuantiFERON TB (tuberculosis) test within 2 months prior to or during screening. Patients with a positive QuantiFERON TB test may participate in the study if further work up including a chest X-ray (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis and initiation of treatment during the conduct of this study is not needed. If presence of latent tuberculosis is established, then treatment according to local country guidelines must have been initiated and completed prior to study initiation.
• Active HBV (Hepatitis B Virus) and HCV (Hepatitis C Virus), defined as:
• HBV: hepatitis B surface antigen (HBs Ag) positive (+),HBcAb positive or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab);
• HCV: HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab).
• Positive screen for drugs of abuse, alcohol or cotinine at Screening.
• Use of known inhibitors or inducers of CYP1A2, 2C9, 2C19, 2D6 or 3A4, including dietary supplements or herbal products containing St. John's wort (Hypericum perforatum) or other known CYP inducers or inhibitors within 30 days or 5 half-lives, whichever is greater prior to study CYP cocktail probe drug administration.
• Use of grapefruits, Seville oranges (sour or bitter oranges), starfruit and their juices, quinine, tonic water, dietary/herbal supplements and inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) and organic anion-transporting polypeptide 1B1/1B3 (OATP1B1/1B3) transporters within 14 days or 5 half-lives of the respective medication before CYP cocktail probe drug administration.

Sponsors & Collaborators

• AbbVie: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Related Publications (1)

• Khatri A, Cheng L, Camez A, Ignatenko S, Pang Y, Othman AA. Lack of Effect of 12-Week Treatment with Risankizumab on the Pharmacokinetics of Cytochrome P450 Probe Substrates in Patients with Moderate to Severe Chronic Plaque Psoriasis. Clin Pharmacokinet. 2019 Jun;58(6):805-814. doi: 10.1007/s40262-018-0730-x.

  PMID: 30574672 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Caffeine; Warfarin; Omeprazole; Metoprolol; Midazolam; risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Benzodiazepines; Benzazepines

Study Officials

• Lawrence Mcnamee

  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: May 12, 2016
• First Posted: May 13, 2016
• Study Start: September 15, 2016
• Primary Completion: June 15, 2017
• Study Completion: September 22, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

DE (1)