Healthy VolunteersPhase 1NCT06793943
A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults
A Phase 1 study testing Zasocitinib, COC and Metformin in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial summary
The main aim of this study is to find out how zasocitinib (TAK-279) interacts with other medicines taken by mouth (orally). This will be examined by how the body processes medicines, which is called pharmacokinetics or PK. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Zasocitinib, COC and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 30 Mar 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs) as outlined 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 screening visit.
Who cannot join
- 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, 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.
- 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.
- Has made a donation of blood or had significant blood loss within 56 days prior to first dosing.
Show all 21Show fewer
- 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 trial to 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-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:
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 4-Part Trial to Assess the Drug-Drug Interaction Between Zasocitinib and Combined Oral Contraceptives, a MATE Substrate, a P-gp Substrate, and a Proton-Pump Inhibitor in Healthy Participants
The main aim of this study is to find out how zasocitinib (TAK-279) interacts with other medicines taken by mouth (orally). This will be examined by how the body processes medicines, which is called pharmacokinetics or PK. In this study, other medicines that will be administered together with zasocitinib include a contraceptive (levonorgestrel (LNG) and ethinyl estradiol [EE]), a medicine for diabetes (metformin), a medicine used for heart problems (digoxin), and a medicine that blocks the production of stomach acid (esomeprazole).
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.
Read the detailed description
The drug being tested in this study is called zasocitinib.
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
- Healthy Volunteers
- Being tested
- Zasocitinib, COC, Metformin, Digoxin, Esomeprazole
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZasocitinibDrug
Also called TAK- 279
Zasocitinib tablets specified doses on specified days.
COCDrug
COC tablets (containing LNG and EE) specified doses on specified days.
MetforminDrug
Metformin tablets specified doses on specified days.
DigoxinDrug
Digoxin tablets specified doses on specified days.
EsomeprazoleDrug
Esomeprazole capsules specified doses on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: COC (LNG and EE) + Zasocitinib | Experimental | Not described Receives: Drug: Zasocitinib; Drug: COC |
| Part 2: Metformin + Zasocitinib | Experimental | Not described Receives: Drug: Zasocitinib; Drug: Metformin |
| Part 3: Digoxin + Zasocitinib | Experimental | Not described Receives: Drug: Zasocitinib; Drug: Digoxin |
| Part 4: Zasocitinib + Esomeprazole | Experimental | Not described Receives: Drug: Zasocitinib; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib
Measured: Up to 144 hours
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for LNG and EE When Administered Alone and With Zasocitinib
Measured: Up to 144 hours
Part 1: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for LNG and EE When Administered Alone and With Zasocitinib
Measured: Up to 144 hours
Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib
Measured: Up to 48 hours
Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib
Measured: Up to 48 hours
Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib
Measured: Up to 48 hours
Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib
Measured: Up to 144 hours
Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib
Measured: Up to 144 hours
Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib
Measured: Up to 144 hours
Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole
Measured: Up to 120 hours
Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole
Measured: Up to 120 hours
Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole
Measured: Up to 120 hours
Secondary outcomes (1)
Parts 1, 2, 3 and 4: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Measured: Part 1: Up to 33 days; Part 2: Up to 23 days; Part 3: Up to 27 days; Part 4: Up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start23 Jan 2025
- Primary completion11 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793943
- Sponsor's protocol ID
- TAK-279-1011
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 4-Part Trial to Assess the Drug-Drug Interaction Between Zasocitinib and Combined Oral Contraceptives, a MATE Substrate, a P-gp Substrate, and a Proton-Pump Inhibitor in Healthy Participants
- ClinicalTrials.gov ID
- NCT06793943
- Acronym / sponsor ID
- TAK-279-1011
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to find out how zasocitinib (TAK-279) interacts with other medicines taken by mouth (orally). This will be examined by how the body processes medicines, which is called pharmacokinetics or PK. In this study, other medicines that will be administered together with zasocitinib include a contraceptive (levonorgestrel (LNG) and ethinyl estradiol [EE]), a medicine for diabetes (metformin), a medicine used for heart problems (digoxin), and a medicine that blocks the production of stomach acid (esomeprazole).
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.
Detailed description
The drug being tested in this study is called zasocitinib.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: COC (LNG and EE) + Zasocitinib | Experimental | Drug: Zasocitinib, Drug: COC |
| Part 2: Metformin + Zasocitinib | Experimental | Drug: Zasocitinib, Drug: Metformin |
| Part 3: Digoxin + Zasocitinib | Experimental | Drug: Zasocitinib, Drug: Digoxin |
| Part 4: Zasocitinib + Esomeprazole | Experimental | Drug: Zasocitinib, Drug: Esomeprazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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, physical examination, laboratory profiles, vital signs, and Electrocardiograms (ECGs) as outlined in the protocol.
- Healthy, adult, female, aged 18 to 65 years, inclusive, at the screening visit.
- Healthy, adult, male or female, aged 18 to 55 years, inclusive, at the screening visit.
Key exclusion criteria (21 listed)
- Positive urine drug or alcohol results at the screening visit or at check-in.
- Unable to refrain from or anticipates the use of:
- 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.
- Has made a donation of blood or had significant blood loss within 56 days prior to first dosing.
- Has made a plasma donation within 7 days prior to first dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZasocitinibAlso: TAK- 279Zasocitinib tablets specified doses on specified days. | Drug | Part 1: COC (LNG and EE) + Zasocitinib, Part 2: Metformin + Zasocitinib, Part 3: Digoxin + Zasocitinib, Part 4: Zasocitinib + Esomeprazole |
| COCCOC tablets (containing LNG and EE) specified doses on specified days. | Drug | Part 1: COC (LNG and EE) + Zasocitinib |
| MetforminMetformin tablets specified doses on specified days. | Drug | Part 2: Metformin + Zasocitinib |
| DigoxinDigoxin tablets specified doses on specified days. | Drug | Part 3: Digoxin + Zasocitinib |
| EsomeprazoleEsomeprazole capsules specified doses on specified days. | Drug | Part 4: Zasocitinib + Esomeprazole |
Primary outcome
Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for LNG and EE When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 1: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for LNG and EE When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib
Time frame: Up to 48 hours
Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib
Time frame: Up to 48 hours
Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib
Time frame: Up to 48 hours
Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole
Time frame: Up to 120 hours
Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole
Time frame: Up to 120 hours
Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole
Time frame: Up to 120 hours
1 secondary outcome
Parts 1, 2, 3 and 4: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Part 1: Up to 33 days; Part 2: Up to 23 days; Part 3: Up to 27 days; Part 4: Up to 23 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zasocitinib, COC and Metformin in people with Healthy Volunteers, run by Takeda at 1 site in United States.
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 6 inclusion and 21 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 4 Apr 2025. 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 United States. 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?
Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib (time frame: Up to 144 hours). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.