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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071210007

Registered date:08/04/2021

A Study of TAK-861 in Healthy Adult

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealthy Volunteers
Date of first enrollment02/04/2021
Target sample size245
Countries of recruitmentUnited States,Japan
Study typeInterventional
Intervention(s)Part A: SRD in Japanese Healthy Adults Single dose: TAK-861 Dose A or placebo-matching, on Day 1, and will be discharged on Day 6. Food effect: Participants in Cohort A3 and A10 (A10 is an optional Cohort) will return at least after 5 days of discharge. TAK-861 Dose A or matching placebo on Day 1 under fasted conditions in Treatment Period 1, followed by TAK-861 Dose A or matching placebo, under fed conditions in Treatment Period 2. Part B: Multiple-Rising Dose (MRD) in Japanese Healthy Adults TAK-861 or TAK-861 placebo-matching, daily for 14 days in Cohorts B1 to B6. Part C: Multiple Dose in Japanese Healthy Elderly Participants TAK-861 or TAK-861 placebo-matching, daily for 14 days in Cohort C1. Part D: MRD in Japanese and Non-Japanese Participants TAK-861 or TAK-861 placebo-matching, for 28 days in Cohorts D1 and D2. Dose will be administered as same or a lower dose than those previously administered in Part B.

Outcome(s)

Primary Outcome1.Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) Time Frame: Part A: Baseline up to Day 9 (single dose) and Day 23 (food effect); Parts B and C: Baseline up to Day 21; Part D: Baseline up to Day 56 2.Number of Participants With at Least one Markedly Abnormal Value (MAV) for Laboratory Assessments Post-dose Time Frame: Part A: Baseline up to Day 9 (single dose) and Day 23(food effect); Parts B and C: Baseline up to Day 21; Part D: Baseline up to Day 56 3.Number of Participants With at Least one MAV for Vital Signs Post-dose Time Frame: Part A: Baseline up to Day 9 (single dose) and Day 23 (food effect); Parts B and C: Baseline up to Day 21; Part D: Baseline up to Day 56 4.Number of Participants With at Least one MAV for Electrocardiograms (ECGs) Post-dose Time Frame: Part A: Baseline up to Day 9 (single dose) and Day 23 (food effect); Parts B and C: Baseline up to Day 21; Part D: Baseline up to Day 56
Secondary Outcome1.Pharmacokinetics parameters of TAK-861 and details are to be determined.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaHealthy Adult Participants for Part A, Band C: 1. Must be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be less than (<) 140 millimeter of mercury (mmHg) (systolic) and <90 mmHg (diastolic) at screening and at Day -1. 2. Must be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before the first dose of study drug or first study assessment. Healthy Adult Participants (Parts A and B ): 3. Must be aged 18 to 55 years, inclusive, at the screening visit. Healthy Elderly Participants (Part C): 4. Must be aged >=65 years, inclusive, at the screening visit. Participants for Parts D: 5. Must be aged 18 to 64 years, inclusive, at the time of informed consent.
Exclude criteriaAll Participants: 1. Has a known hypersensitivity to any component of the formulation of TAK 861 or related compounds. 2. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. Healthy Adult Participants for Parts A, B, and C: 3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 mL/12 ounce (oz)], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).

Related Information

Contact

Public contact
Name Trial Information Contact for Clinical
Address 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone +81-6-6204-2111
E-mail smb.Japanclinicalstudydisclosure@takeda.com
Affiliation Takeda Pharmaceutical Company Limited
Scientific contact
Name Hidenori Nonomura
Address 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone +81-6-6204-2111
E-mail smb.Japanclinicalstudydisclosure@takeda.com
Affiliation Takeda Pharmaceutical Company Limited