A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults

NCT06793943 | Completed Phase 1 FDA Drug

• 1 other identifier: TAK-279-1011
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (12)

• Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib

  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

  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

  Up to 144 hours

• Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib

  Up to 48 hours

• Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib

  Up to 48 hours

• Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib

  Up to 48 hours

• Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib

  Up to 144 hours

• Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib

  Up to 144 hours

• Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib

  Up to 144 hours

• Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole

  Up to 120 hours

• Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole

  Up to 120 hours

• Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole

  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)

  Part 1: Up to 33 days; Part 2: Up to 23 days; Part 3: Up to 27 days; Part 4: Up to 23 days

Study Arms (4)

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

Interventions

Zasocitinib DRUG

Zasocitinib tablets specified doses on specified days.

Also known as: TAK- 279

Part 1: COC (LNG and EE) + Zasocitinib; Part 2: Metformin + Zasocitinib; Part 3: Digoxin + Zasocitinib; Part 4: Zasocitinib + Esomeprazole

COC DRUG

COC tablets (containing LNG and EE) specified doses on specified days.

Part 1: COC (LNG and EE) + Zasocitinib

Metformin DRUG

Metformin tablets specified doses on specified days.

Part 2: Metformin + Zasocitinib

Digoxin DRUG

Digoxin tablets specified doses on specified days.

Part 3: Digoxin + Zasocitinib

Esomeprazole DRUG

Esomeprazole capsules specified doses on specified days.

Part 4: Zasocitinib + Esomeprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• 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.

MeSH Terms

Interventions

Metformin; Digoxin; Esomeprazole

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 23, 2025
• Primary Completion: March 11, 2025
• Study Completion: March 30, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)