A Study of TAK-279 in Adults With or Without Kidney Problems

NCT05992155 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TAK-279-1003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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 kidney problems compared to participants without kidney 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

Renal Impairment; Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-279

  Predose to Day 10

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

  Predose to Day 10

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

  Predose to Day 10

Secondary Outcomes (6)

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

  From study start through 14 days after last dose administration (up to approximately 42 days)

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

  From study start through 14 days after last dose administration (up to approximately 42 days)

• Number of Participants With Markedly Abnormal Values for Vital Signs

  Up to Day 10

• Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings

  Up to Day 10

• Number of Participants With Markedly Abnormal Laboratory Values

  Up to Day 10

Study Arms (3)

Cohort 1, Severe RI: TAK-279 50 mg

EXPERIMENTAL

Participants with severe RI 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 Renal Function: TAK-279 50 mg

EXPERIMENTAL

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

Drug: TAK-279

Cohort 3, Moderate RI: TAK-279 50 mg

EXPERIMENTAL

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

Drug: TAK-279

Interventions

TAK-279 DRUG

TAK-279 capsules.

Cohort 1, Severe RI: TAK-279 50 mg; Cohort 2, Normal Renal Function: TAK-279 50 mg; Cohort 3, Moderate RI: 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 RI:
• 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 kg and has a body mass index (BMI) ≥18.0 and ≤39.0 kilograms per meters squared (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 RI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Investigator or designee, including:
• Supine blood pressure (BP) is ≥90/40 mmHg (asymptomatic) and ≤180/100 mmHg, at screening;
• Supine pulse rate (PR) is ≥40 beats per minute (bpm) and ≤99 bpm, at screening;
• Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin within the upper limit of normal (ULN) at screening and at check-in.
• Creatine phosphokinase (CPK) ≤ ULN at the screening visit and at check-in.
• Amylase and lipase ≤ ULN at the screening visit and at check-in.
• Estimated glomerular filtration rate (eGFR) based on the Modification of Diet in Renal Disease (MDRD) equation at screening as follows,
• Severe RI: \<30 milliliters per minute (mL/min), not on dialysis;
• Moderate RI: 30-59 mL/min.
• Has chronic RI for at least 3 months before screening, and the RI must be stable, i.e., no significant changes (i.e., ≥30%) in renal function in the 30 days preceding screening (or since the last visit if within 6 months before screening) and treatment with stable doses of medication.

You may not qualify if:

• A. Participants with RI:
• 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 RI) 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 (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis);
• Cancer or lymphoproliferative disease with the exception of successfully treated nonmelanoma skin cancer (NMSC) or basal cell carcinoma and/or localized carcinoma in situ of the cervix;
• Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy;
• Has had a failed renal transplant or a nephrectomy.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (3)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Research by Design

Chicago, Illinois, 60643, United States

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: August 8, 2023
• First Posted: August 15, 2023
• Study Start: September 27, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 28, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

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 (3)