Healthy Volunteers
Conditions
Interventions
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,
Sponsors
Nonomura Hidenori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 (=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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1.Pharmacokinetics parameters of TAK-861 and details are to be determined. | — |
Countries
Japan, United States
Contacts
Public ContactTrial Information Contact for Clinical
Takeda Pharmaceutical Company Limited
Outcome results
None listed