Direct Helpers Research Center | Hialeah, FL
Status and phase
Conditions
Treatments
About
The primary objective of the study is to evaluate the pharmacokinetics (PK) of multiple cytochrome P450 (CYP450) substrates alone and in combination with rocatinlimab in participants with moderate to severe atopic dermatitis (AD).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in
The use of any of the following treatments within 4 weeks before Check-in:
The use of any of the following treatments within one week before Check-in:
Administration, within 14 days before baseline or within a period of 5 times the elimination half-life of the medication before baseline, whichever is longer, of any medication that is a known inducer or inhibitor of either one or more of the following cytochrome P450 (CYP) enzymes: CYP3A4, CYP2C19, CYP2C9, CYP2D6, and CYP1A2. Participants who are on any of these medications at the time of screening and cannot be safely taken off these medications will be excluded from the study.
Any contraindication to one or more of the following drugs, according to the applicable labeling:
Consumption of any 1 or more of the following food items and/or beverages within 1 week prior to Check-in:
History of alcoholism or drug/chemical abuse within 1 year prior to Check-in or regular alcohol consumption (>14 units per week for males and >7 units for females)
Smoke more than 10 cigarettes or use the equivalent (as determined by site staff) tobacco- or nicotine-containing products per day and unwilling to adhere to smoking restrictions.
Poor metabolizers for CYP2C9, CYP2C19, or CYP2D6 based on genotyping
Presence of any one or more of the following lab abnormalities at screening or Check-in:
• Platelet count <100k /µL, international normalized ratio (INR)>1.2, prothrombin time (PT)>13.5 sec or partial thromboplastin time (PTT)>35 sec
Active, chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals at screening or Check-in
Superficial skin infections, including tinea infections, within 2 weeks prior to Check-in
History of acquired, common variable, primary or secondary immunodeficiency
Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test, at screening as per Center for Disease Control interpretation. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included. Participants with positive hepatitis B core antibody will be excluded.
Active malignancy, multiple myeloma, myeloproliferative or lymphoproliferative disorder, or a history of any of these conditions within 5 years prior to informed consent (except curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma)
Diagnosis of a helminth parasitic infection within 6 months prior to screening that had not been treated with or failed to respond to standard of care therapy.
History of suicidal ideation (thoughts), suicide-related behaviors, suicide attempt(s), depression or major psychiatric illness within 6 months prior to signing the informed consent
Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study through 18 weeks after the end of study visit
Unwilling to adhere to contraceptive requirements through 18 weeks after the end of study visit
Male participant with a pregnant partner or partner planning to become pregnant while the participant is on study through 18 weeks after the end of study visit
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
Loading...
Central trial contact
Amgen Call Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal