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Study type
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About
To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a means of predicting drug-drug interactions.
Enrollment
Sex
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Volunteers
Inclusion criteria
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:
OR
Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Females must have negative results for pregnancy tests performed:
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.
Further inclusion criteria apply.
Exclusion criteria
Patients with
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:
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.
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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