phase 1 tak-925 study in healthy adult and elderly volunteers and participants with narcolepsy

Conditions: Healthy Participants and Patients With Narcolepsy

Summary: the purpose of this study is to investigate safety, tolerability, and pharmacokinetics of tak-925 when a single dose of tak-925 is administered to healthy adult participants, healthy elderly participants and patients with type 1 narcolepsy.

orexins are neuropeptides that play a role in the regulation of sleep and wakefulness. in type 1 narcolepsy, there is a loss of orexin producing neurons in the brain. the investigational drug, tak-925, is an orexin 2 receptor agonist that is being tested in healthy adult participants, healthy elderly participants and patients with narcolepsy in order to evaluate the safety, tolerability, and pharmacokinetics (pk) of a single intravenous administration. the study will enroll approximately 20 healthy participants and 16 healthy elderly participants in part 1 of the study and approximately 20 patients with narcolepsy in part 2. in part 1, the study consists of 4 cohorts of 8 or 4 participants each. participants will be randomly assigned (by chance, like flipping a coin) to one of the following treatment groups to receive tak-925 or placebo: - part 1, cohort 1; tak-925 (dose level 1, 3, 5), cohort 2; tak-925 (dose level 2, 4, 6), cohort 3 and 4; tak-925 (dose level 5) for cohort 1-4, healthy adult and elderly participants will be administered tak-925 or placebo once in each cohort or dose level. the dose at the start (cohort 1 dose level 1) is 7 mg of tak-925 and following doses in cohorts 1-4 will be determined based on available data from previous cohorts/dose levels. in part 2 of the study, the study consists of 3 cohorts of 4 to 12 patients with narcolepsy. patients will be randomly assigned to one of the treatment groups of cohort 5-7 and will be administered tak-925 or placebo once in each cohort. the dose of tak-925 in cohort 5-7 is tbd and will be decided based on available data from part 1 and previous cohorts. - part 2, cohort 5-7 this multi-center trial will be conducted in japan. participants will make multiple visits to the clinic. visits in part 1 will include a screening period (day -28 to -2), check-in on day -1, treatment period (day 1 and 2), and follow-up visit on day 7. in part 2 of the study, the visits include a screening period (day -42 to -2), check-in on day -1, cross-over period (day 1 to 4), and follow-up visit on day 7.

Eligibility criteria:
inclusion criteria: healthy adult participants and healthy elderly participants: - participant weighs at least 50 kilogram (kg) (healthy adults participants) / 40 kg (healthy elderly participants) and has a body mass index (bmi) from 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at screening. narcolepsy patients: * patient weighs at least 40 kg inclusive at screening. * a diagnosis of narcolepsy type 1, as defined by the international classification of sleep disorders, third edition (icsd-3). * hla narcolepsy test positivity. * at day -1, epworth sleepiness scale (ess) score greater than or equal to (\>=) 10 * blood pressure less than (\<) 140 systolic and \< 90 diastolic. the patient may have a history of hypertension and be on antihypertensive medication treatment as long as the bp meets these criteria. exclusion criteria: all participants: * participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the screening visit. * past or current epilepsy, convulsion, tremor or the disorders of related symptoms. * has a lifetime history of major psychiatric disorder, such as major depressive disorder, bipolar disorder, or schizophrenia. hv (only cohort 4): - participant has had csf collection performed within 14 days prior to check-in (day -1). narcolepsy patients * medical disorder associated with excessive sleepiness other than narcolepsy (including sleep apnea syndrome). * excessive caffeine (greater than \[\>\] 400 milligram per day \[mg/day\]) use one week prior to study.