A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults
NCT ID: NCT06793943
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
78 participants
INTERVENTIONAL
2025-01-23
2025-03-30
Brief Summary
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Another aim is to learn about the side effects of zasocitinib and how well it is tolerated when taken alone and together with these other medicines.
During the study, participants will need to stay at the clinic for up to 27 days.
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Detailed Description
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Zasocitinib is being tested to assess the effect of zasocitinib on the pharmacokinetics of Combined Oral Contraceptive (COC \[containing LNG and EE\] in Part 1), multidrug and toxic compound extrusion (MATE) substrate (metformin in Part 2), and a P-glycoprotein (P-gp) substrate (digoxin in Part 3). Additionally, the effect of proton-pump inhibitor (PPI) (esomeprazole in Part 4) on the pharmacokinetics of zasocitinib is being evaluated in healthy participants.
The study will enroll approximately 78 participants. Participants will be enrolled in one of the four parts to evaluate the following treatments:
* Part 1: COC (LNG and EE) + Zasocitinib
* Part 2: Metformin + Zasocitinib
* Part 3: Digoxin + Zasocitinib
* Part 4: Zasocitinib + Esomeprazole
The overall time (including screening and follow-up periods) to participate is approximately 68 days for Part 1, 54 days for Part 2, 62 days for Part 3 and 56 days for Part 4. All participants will be followed up for up to 14 days after the last dose of Period 2 in each Part.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Part 1: COC (LNG and EE) + Zasocitinib
Zasocitinib
Zasocitinib tablets specified doses on specified days.
COC
COC tablets (containing LNG and EE) specified doses on specified days.
Part 2: Metformin + Zasocitinib
Zasocitinib
Zasocitinib tablets specified doses on specified days.
Metformin
Metformin tablets specified doses on specified days.
Part 3: Digoxin + Zasocitinib
Zasocitinib
Zasocitinib tablets specified doses on specified days.
Digoxin
Digoxin tablets specified doses on specified days.
Part 4: Zasocitinib + Esomeprazole
Zasocitinib
Zasocitinib tablets specified doses on specified days.
Esomeprazole
Esomeprazole capsules specified doses on specified days.
Interventions
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Zasocitinib
Zasocitinib tablets specified doses on specified days.
COC
COC tablets (containing LNG and EE) specified doses on specified days.
Metformin
Metformin tablets specified doses on specified days.
Digoxin
Digoxin tablets specified doses on specified days.
Esomeprazole
Esomeprazole capsules specified doses on specified days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs) as outlined in the protocol.
Part 1 Only:
3. Healthy, adult, female, aged 18 to 65 years, inclusive, at the screening visit.
Parts 2-4 Only:
4. Healthy, adult, male or female, aged 18 to 55 years, inclusive, at the screening visit.
Exclusion Criteria
2. Unable to refrain from or anticipates the use of:
* Any drugs, including prescription and non-prescription medications, herbal remedies, 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.
3. Has been on a diet incompatible with the on-trial diet, in the opinion of the investigator or designee, within the 30 days prior to first dosing and throughout the trial.
4. Has made a donation of blood or had significant blood loss within 56 days prior to first dosing.
5. Has made a plasma donation within 7 days prior to first dosing.
6. 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 trial to Day 1 of Period 1 of the current trial.
7. Has herpes infections.
8. Positive results for non-herpetic viral diseases at the screening visit.
9. Positive results for tuberculosis (TB) at the screening visit.
Part 1:
10. 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-containing product, within 12 weeks prior to the first dosing.
* Any injectable or implantable hormone-containing product within 1 year prior to the first dosing.
Part 2 Only:
11. Hemoglobin A1c (HbA1c) greater than (\>) ULN (5.7 percentage \[%\]) and deemed clinically significant by the investigator or designee at the screening visit.
Part 3 Only:
12. Has or is at risk for major cardiac events or dysfunction.
Part 4 Only:
13. Had diarrhea or vomiting within 48 hours prior to check-in.
18 Years
65 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Celerion
Tempe, Arizona, United States
Countries
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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TAK-279-1011
Identifier Type: -
Identifier Source: org_study_id
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