Phase
Condition
Healthy Volunteers
Treatment
COC
Esomeprazole
Zasocitinib
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilograms per square meter (kg/m^2) at the screening visit.
Medically healthy with no clinically significant medical history, physicalexamination, laboratory profiles, vital signs, and Electrocardiograms (ECGs) asoutlined in the protocol. Part 1 Only:
Healthy, adult, female, aged 18 to 65 years, inclusive, at the screening visit. Parts 2-4 Only:
Healthy, adult, male or female, aged 18 to 55 years, inclusive, at the screeningvisit.
Exclusion
Exclusion criteria:
Positive urine drug or alcohol results at the screening visit or at check-in.
Unable to refrain from or anticipates the use of:
Any drugs, including prescription and non-prescription medications, herbalremedies, or vitamin supplements and other drugs outlined in protocol.
Any drugs known to be inducers of Cytochrome P450 3A4 (CYP3A4) and/or P-gp,including St. John's Wort, for 28 days prior to the first dosing.
Has been on a diet incompatible with the on-trial diet, in the opinion of theinvestigator or designee, within the 30 days prior to first dosing and throughoutthe trial.
Has made a donation of blood or had significant blood loss within 56 days prior tofirst dosing.
Has made a plasma donation within 7 days prior to first dosing.
Participated in another clinical trial within 30 days prior to first dosing. The 30-day window will be derived from the date of the last dosing in the previous trialto Day 1 of Period 1 of the current trial.
Has herpes infections.
Positive results for non-herpetic viral diseases at the screening visit.
Positive results for tuberculosis (TB) at the screening visit. Part 1:
Unable to refrain from or anticipates the use of:
Any drugs known to increase or decrease levels of sex hormone-binding globulin (SHBG), including any oral, topical, or intravaginal hormone-containingproduct, within 12 weeks prior to the first dosing.
Any injectable or implantable hormone-containing product within 1 year prior tothe first dosing. Part 2 Only:
Hemoglobin A1c (HbA1c) greater than (>) ULN (5.7 percentage [%]) and deemedclinically significant by the investigator or designee at the screening visit. Part 3 Only:
Has or is at risk for major cardiac events or dysfunction. Part 4 Only:
Had diarrhea or vomiting within 48 hours prior to check-in.
Study Design
Study Description
Connect with a study center
Celerion
Tempe, Arizona 85283
United StatesSite Not Available
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