A Study of TAK-279 in Healthy Chinese Adults

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: TAK-279; Drug: Placebo

• Registration Number: NCT06111547
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-01
• Study Start: 2024-06-24
• Primary Completion: 2024-07-23
• Status Verified: 2024-08
• Study Completion: 2024-08-04
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: TAK-279 30 mg	TAK-279	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.
Cohort 2: TAK-279 60 mg	TAK-279	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.
Cohort 1 and 2: Placebo 30 mg or 60 mg	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Cmax of TAK-279 in plasma will be assessed.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Cmax,ss of TAK-279 in plasma will be assessed.
Area Under the Concentration-time Curve From Time 0 To Infinity (AUC0-inf) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	AUC0-inf of TAK-279 in plasma will be assessed.
Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	AUC0-t of TAK-279 in plasma will be assessed.
Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	AUCtau of TAK-279 in plasma will be assessed.

Secondary Outcome Measures

Name	Time	Method
Average Plasma Concentration (Cavg) for TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Cavg of TAK-279 will be assessed, calculated as AUC(tau)/tau. Tau is defined as length of dosing interval.
Accumulation Ratio for Cmax (RA, Cmax) of TAK-279	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	Accumulation ratio calculated from Cmax,ss at steady state and Cmax indicated a single dose will be assessed.
Accumulation Ratio for AUCtau (RA, AUCtau) of TAK-279	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	Accumulation ratio calculated from AUCtau at steady state and AUC0-24 indicated a single dose will be assessed.
Apparent Volume of Distribution at Steady State (Vss/F) of TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Vss/F of TAK-279 will be assessed.
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)	Number of participants with clinically significant changes in ECG, vital signs, and clinical laboratory parameters will be assessed. Clinical significance of ECG, vital signs, and clinical laboratory parameters will be determined at the investigator's discretion.
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	t1/2 of TAK-279 in plasma will be assessed.
Trough Concentration (Ctrough) of TAK-279	Pre-dose on Day 17, Day 18 and Day 19	Ctrough of TAK-279 will be assessed.
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	Lambda z of TAK-279 in plasma will be assessed.
Apparent Clearance (CL/F) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	CL/F of TAK-279 in plasma will be assessed.
Minimum Plasma Concentration (Cmin) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Cmin of TAK-279 will be assessed.
Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Tmax,ss of TAK-279 will be assessed.
Total Body Drug Clearance at Steady State (CLss/F) of TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	CLss/F of TAK-279 will be assessed.
Percent peak-to-trough fluctuation (%FLUC) of TAK-279	Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Percent peak-to-trough fluctuation will be assessed, calculated as 100%\*(\[Cmax,ss-Ctrough\]/Cavg) will be assessed.
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 TEAEs, serious TEAEs and AESI will be reported.
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	AUC0-24 of TAK-279 in plasma will be assessed.
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Vz/F of TAK-279 in plasma will be assessed.
Time to Reach Peak Plasma Concentration (Tmax) of TAK-279	Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose	Tmax of TAK-279 in plasma will be assessed.

Trial Locations

Locations (1)

Huashan Hospital Fudan University; 🇨🇳 Shanghai, China