A Study of TAK-861 in Healthy Adults and Subjects With Narcolepsy Type 1

JRCT ID: jRCT2071210007

Registered date:08/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Volunteers
• Date of first enrollment: 02/04/2021
• Target sample size: 263
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

Part A: SRD in Japanese Healthy Adults
Single dose: TAK-861 or placebo-matching, on Day 1, and will be discharged on Day 6. Subsequent dose levels will be determined by emerging safety, tolerability, and PK data.

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 with NT1
TAK-861 or TAK-861 placebo-matching, for 28 days.
Dose will be administered as same or a lower dose than those previously administered in Part B.

Outcome(s)

Primary Outcome

1.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 Outcome: 1.Pharmacokinetics parameters of TAK-861 and details are to be determined.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Healthy Adult Participants for Part A, B, 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, B):
3. Must be aged 18 to 55 years, inclusive, at the screening visit.
4. Must have a body weight >=50 kg at the screening visit.

Healthy Elderly Participants (Part C):
5. Must be aged >=65 years, inclusive, at the screening visit.
6. Must have a body weight >=40 kg at the screening visit.

Participants With NT1 (Parts D):
7. Must be aged 18 to 64 years, inclusive, at the time of informed consent.
8. Must have a diagnosis of NT1 by polysomnography (PSG)/multiple sleep latency test (MSLT) performed within the past 10 years meeting the minimal acceptable criteria for the proper performance of PSG/MSLT as outlined by the ICSD-3 criteria.
9. ESS score must be >=10 at Day -1.
10. Must be willing to discontinue all medications used for the treatment of NT1.
11. The participant must have a BMI >=18.0 and =<40 kg/m2 at the screening visit.
12. The participant must have BP <140 mm Hg (systolic) and <90 mm Hg (diastolic) at the screening visit and Day -2.

Exclude criteria

All Participants:
1. Have a known hypersensitivity to any component of the formulation of TAK 861 or related compounds.
2. Consumes excessive amounts, defined as greater than 600mg of caffeine of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.

Participants With NT1 for Parts D - Additional Criteria
3. Have a medical disorder, other than narcolepsy, associated with EDS.
4. Have any other medical condition, such as anxiety, depression, heart disease, or hepatic, pulmonary, or renal disease, that requires the participant to take excluded medications or at the time of screening the participant is being treated with nasal/oronasal PAP for any reason.
5. Have a nicotine dependence that is likely to have an effect on sleep (eg, a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portions of the study.

Related Information

• Primary Sponsor: Nonomura Hidenori