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PsoriasisPhase 1NCT02772601

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

A Phase 1 study testing Caffeine, Warfarin and Omeprazole in people with Psoriasis, run by AbbVie at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis
What is being tested?
Caffeine, Warfarin and Omeprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteGermany
Study dates
15 Sep 2016to 22 Sep 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Age < 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L.
  • OR
  • 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.
  • Vasectomized partner(s), provided the vasectomized partner has received medical assessment of the surgical success and is the sole sexual partner of the WOCBP trial participant.
  • Intrauterine device (IUD).
  • Intrauterine hormone-releasing system (IUS).
  • True abstinence: Refraining from heterosexual intercourse-when this is in line with the preferred and usual lifestyle of the subject. (Note: Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable).
  • Further inclusion criteria apply.

Who cannot join

  • 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
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  • 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.
  • Current smokers of nicotine containing products, including those who quit smoking less than 30 days prior to CYP cocktail probe drug administration.
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
  • Plans for administration of live vaccines during the study period or within 6 weeks prior to screening
  • Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Boehringer Ingelheim Investigational Site

    Berlin

Other trials in Germany

About this study

Official title: The Effect of Multiple Subcutaneous Doses of Risankizumab on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) Administered Orally in an Open-label, One-sequence Trial in Patients With Plaque Psoriasis With or Without Concomitant Psoriatic Arthritis

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

Conditions
Psoriasis
Being tested
Caffeine, Warfarin, Omeprazole, Metoprolol, Midazolam
Keywords
ABBV-066, BI 655066, risankizumab
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02772601
Study groupRoleWhat they receive
All patientsExperimentalNot described
Receives: Drug: Caffeine; Drug: Warfarin; Drug: Omeprazole; Drug: Metoprolol; Drug: Midazolam; Drug: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 98-101

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

    Measured: Day 1-3

  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

    Measured: Day 98 - 105

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

    Measured: Day 1-8

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

    Measured: Day 98 - 100

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

    Measured: Day 1-2

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

    Measured: Day 98 -100

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

    Measured: Day 1-3

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

    Measured: Day 98 - 99

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

    Measured: Day 1-2

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

    Measured: Day 1

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

    Measured: Day 98

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

    Measured: Day 1

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

    Measured: Day 98

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

    Measured: Day 1

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

    Measured: Day 98

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

    Measured: Day 1

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

    Measured: Day 98

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

    Measured: Day 1

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

    Measured: Day 98

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2016 (estimated)
  2. Study start15 Sep 2016
  3. Primary completion15 Jun 2017
  4. Study completion22 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02772601
Sponsor's protocol ID
M16-007
Other IDs
2015-005523-31, 1311.36, 2015
Status last verified
Sep 2017
First submitted
12 May 2016
Last updated
25 Sep 2017
Results posted
No

Publications

  • 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.

    PubMed 30574672

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Caffeine, Warfarin and Omeprazole in people with Psoriasis, run by AbbVie at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point (time frame: Day 98-101). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02772601, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.

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