A Study of TAK-279 in Healthy Chinese Adults

NCT06111547 | Completed Phase 1

• 1 other identifier: TAK-279-1005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to find out how the body of a healthy Chinese adult processes TAK-279 (pharmacokinetics). Other aims are to learn about side effects and how well TAK-279 is tolerated when given to healthy Chinese Adults. Participants will receive either TAK-279 or a placebo on Day 1 and from Day 6 to Day 19. Blood samples will be taken at different timepoints throughout the study participation. Participants will need to adhere to certain lifestyle restrictions during the study. This also includes eating and drinking restrictions. During the study, participants will need to stay at the clinic for 25 days.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of TAK-279

  AUC0-t of TAK-279 in plasma will be assessed.

  Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

• Area Under the Concentration-time Curve From Time 0 To Infinity (AUC0-inf) of TAK-279

  AUC0-inf of TAK-279 in plasma will be assessed.

  Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

• Maximum Observed Plasma Concentration (Cmax) of TAK-279

  Cmax of TAK-279 in plasma will be assessed.

  Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

• Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of TAK-279

  AUCtau of TAK-279 in plasma will be assessed.

  Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

• Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of TAK-279

  Cmax,ss of TAK-279 in plasma will be assessed.

  Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

Secondary Outcomes (17)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)

  From start of study drug administration up to follow-up (up to Day 36)

• Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG), Vital Signs and Clinical Laboratory Parameters

  From start of study drug administration up to follow-up (up to Day 36)

• Area Under the Plasma Concentration-Time Curve From Time 0 To the Time 24 Hours (AUC0-24) of TAK-279

  Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose

• Terminal Elimination Rate Constant (Lambda z) of TAK-279 at Day 1 and Day 19

  Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

• Terminal phase half-life (t1/2) of TAK-279 at Day 1 and Day 19

  Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose

Study Arms (3)

Cohort 1: TAK-279 30 mg

EXPERIMENTAL

Participants will receive a single dose of TAK-279 30 milligram (mg) oral tablet on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.

Drug: TAK-279

Cohort 2: TAK-279 60 mg

EXPERIMENTAL

Participants will receive a dose of TAK-279 60 mg (2\*30mg) oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.

Drug: TAK-279

Cohort 1 and 2: Placebo 30 mg or 60 mg

PLACEBO COMPARATOR

Participants will receive TAK-279 30 mg or 60 mg (2\*30mg) matching placebo oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.

Drug: Placebo

Interventions

TAK-279 DRUG

TAK-279 oral tablet.

Cohort 1: TAK-279 30 mg; Cohort 2: TAK-279 60 mg

Placebo DRUG

TAK-279 30 mg or 60 mg (2\*30mg) matching placebo tablet.

Cohort 1 and 2: Placebo 30 mg or 60 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing to participate and is capable of giving informed consent.
• Healthy, male or female participants of Chinese descent 18 to 45 years of age, inclusive, at the time of informed consent.
• Female participants meets the following contraception requirements: A surgically sterile female participant; or a female participant of nonchildbearing potential with laboratory confirmation of postmenopausal status (that is follicle-stimulating hormone levels greater than \[\>\] 40 milli-international units per milliliter \[mIU/mL\]); or, if sexually active with a non-sterilized male partner, a female participant who agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the study and for 10 days after the last dose. Male participants must agree to comply with effective contraceptive requirements.
• Body mass index greater than or equal to (\>=) 18.0 kilogram per meter square (kg/m\^2) and less than or equal to (\<=) 28.0 kg/m\^2 at the screening visit.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms \[ECGs\], as deemed by the principal investigator (PI) or designee, including the following:
• Seated blood pressure (BP) (systolic BP/diastolic BP) \>=90/50 millimeters of mercury (mmHg) and \<=140/90 mmHg at the screening visit.
• Seated heart rate or pulse is \>=50 beats per minute (bpm) and \<=100 bpm at the screening visit.
• ECG findings are considered normal or not clinically significant by the PI or designee at the screening visit.
• Participant must be willing and able to understand and fully comply with all study procedures and must be available for the duration of the study.

You may not qualify if:

• Site personnel or their family.
• History or presence of clinically significant medical or psychiatric condition or disease.
• History of any illness or condition that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
• History of allergy to study drug or any of its components.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• Clinical laboratory values at the time of screening or at check-in:
• Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.5 \* the upper limit normal (ULN).
• Creatine phosphokinase (CPK) \> the ULN.
• Hemoglobin \<11.0 grams per deciliter (g/dL) (\<110.0 gram per liter \[g/L\]).
• Absolute neutrophil count \<1.8\*10\^9/liters (L) (\<1800 per cubic millimeter \[/mm\^3\]).
• Absolute lymphocyte count \<0.8\*10\^9/L (\<800/mm\^3).
• Platelet count \<100\*10\^9/L (\<100,000/mm\^3).
• A participant with out-of-range values may have the test repeated once at each time point (screening or check-in) and the participant may be enrolled if the repeated values are within protocol-specified ranges.
• Ingestion of Seville orange- or grapefruit-containing foods or beverages within 7 days prior to check-in.
• History of alcohol abuse or drug/chemical abuse within 2 years prior to check-in.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, 201100, China

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 1, 2023
• Study Start: June 24, 2024
• Primary Completion: July 23, 2024
• Study Completion: August 4, 2024
• Last Updated: August 7, 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

CN (1)