A Study of TAK-279 in Adults With or Without Liver Damage

NCT05976321 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TAK-279-1004
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

Brief Summary

The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. The participants will need to stay at the clinic for 11 days.

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-279

  Predose and at multiple time points post dose from Days 1 to 10

• AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-279

  Predose and at multiple time points post dose from Days 1 to 10

• AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279

  Predose and at multiple time points post dose from Days 1 to 10

Secondary Outcomes (9)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Up to 14 days

• Number of Participants With Adverse Events of Special Interest (AESIs)

  Up to 14 days

• Number of Participants With Clinically Significant Vital Signs

  Up to 10 days

• Number of Participants With Clinically Significant Electrocardiogram Findings

  Up to 10 days

• Number of Participants With Clinically Significant Laboratory Values

  Up to 10 days

Study Arms (3)

Cohort 1, Moderate HI: TAK-279 50 mg

EXPERIMENTAL

Participants with moderate HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study.

Drug: TAK-279

Cohort 2, Normal Hepatic Function: TAK-279 50 mg

EXPERIMENTAL

Participants with normal hepatic function will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part A of the study. Based on an evaluation of the results from Part A, additional participants with normal hepatic function may be enrolled in Part B of the study.

Drug: TAK-279

Cohort 3, Mild/Severe HI: TAK-279 50 mg

EXPERIMENTAL

Participants with mild/severe HI will receive a single oral dose of TAK-279 50 mg, on Day 1 in Part B of the study based on an evaluation of the results from Part A.

Drug: TAK-279

Interventions

TAK-279 DRUG

TAK-279 capsules.

Cohort 1, Moderate HI: TAK-279 50 mg; Cohort 2, Normal Hepatic Function: TAK-279 50 mg; Cohort 3, Mild/Severe HI: TAK-279 50 mg

Eligibility Criteria

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

You may qualify if:

• A. Participants with Hepatic Impairment:
• Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
• Adult male or female participant aged ≥18 years, at screening.
• Has a body weight greater than 50 kilograms (kg) and has a body mass index (BMI) ≥18.0 and ≤42.0 kilograms per meter square (kg/m\^2), at screening.
• Continuous non-smoker or moderate smoker (≤10 cigarettes/day or the equivalent \[including electronic cigarettes\]) before screening. Participant must agree to smoke no more than 5 cigarettes or equivalent/day (including electronic cigarettes) from the 7 days prior to TAK-279 dosing.
• Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, or screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
• Supine blood pressure (BP) is ≥90/40 millimeters of mercury (mmHg) and ≤150/95 mmHg, at screening.
• Supine pulse rate (PR) is ≥40 beats per minute (bpm) and ≤99 bpm, at screening.
• Estimated creatinine clearance (CrCl) ≥60 millilitres per minute (mL/min) (using Cockcroft-Gault formula) at screening. Both estimated CrCl and estimated glomerular filtration rate (eGFR) using modification of diet in renal disease (MDRD) formula will be reported.
• Have had chronic HI for at least 3 months before screening, and the HI must be stable, i.e., no significant changes in hepatic function in the 30 days preceding screening (or since the last visit if within 3 months before screening).
• Has a score on the Child-Pugh Class at screening as follows:
• Severe HI cohort, Child-Pugh Class C: ≥10 and ≤15.
• Moderate HI cohort, Child-Pugh Class B: ≥7 and ≤9.
• Mild HI cohort, Child-Pugh Class A: ≥5 and ≤6.
• Female participants of childbearing potential agree to comply with any acceptable contraceptive requirements of the protocol.

You may not qualify if:

• A. Participants with Hepatic Impairment:
• The participant must be excluded from participating in the study if the participant:
• Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.
• Has history or presence of clinically significant medical or psychiatric condition or disease (aside from HI) in the opinion of the Investigator or designee.
• Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
• Has a history of any of the following:
• Active infection or febrile illness within 7 days prior to dosing, as assessed by the Investigator or designee.
• Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to dosing.
• Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
• An infected joint prosthesis unless that prosthesis has been removed or replaced within 60 days prior to dosing.
• Opportunistic infections (e.g., Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
• Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
• Liver or other solid organ transplant.
• Has history or presence of alcoholism and/or drug abuse within the past 6 months prior to dosing, as determined by the Investigator or designee.
• Has history or presence of clinically significant hypersensitivity or idiosyncratic reaction to the study drug or related compounds.

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

University of Miami

Miami, Florida, 33146, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation - Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

Location

Related Links

• To obtain more information about this study, click this link

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: September 22, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

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 (4)