Status:
WITHDRAWN
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-988 in Healthy Participants
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) ...
Detailed Description
The drug being tested in this study is called TAK-988. TAK-988 is being tested to evaluate safety, tolerability, PK, and PD of single and multiple oral doses in healthy non-Japanese and Japanese adult...
Eligibility Criteria
Inclusion
- 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).
- Healthy Adult and Elderly Participants (Parts A through D)
- Must have a body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2) at the screening visit (non-Japanese only).
- Healthy Adult Participants (Parts A, B, and C)
- Must be aged 18 to 55 years, inclusive, at the screening visit.
- Must have a body weight \>=50 kilogram (kg) at the screening visit.
- HE Participants (Part D)
- Must be aged \>=65 years, inclusive, at the time of informed consent.
- Must have a body weight \>=40 kg at the screening visit.
- Healthy Japanese Adult Participants (Part E)
- Must be aged 18 to 55 years, inclusive, at the screening visit.
- Must have a BMI \>=18.0 and \<=26.0 kg/m\^2 at the screening visit.
- Must have been born in Japan to a Japanese mother and father and have maternal and paternal Japanese grandparents.
- Must have not been away from Japan for more than 10 years at the screening visit.
- In the opinion of the investigator, must have a lifestyle that has not changed significantly since relocation from Japan.
Exclusion
- Has a known hypersensitivity to any component of the formulation of TAK-988 or related compounds.
- Has a risk of suicide according to endorsement of Item 4 or 5 of the screening/baseline visit Columbia Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months.
- Has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia. Participant who have history of major depressive disorder (MDD) may be included, but participants who have current active MDD or who have had active MDD in the past 6 months are excluded.
- Has a clinically significant history of head injury or head trauma.
- Has a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
- Screening electrocardiogram (ECG) reveals a QT interval with the Fridericia's correction method (QTcF) greater than (\>) 450 millisecond (ms) (men) or \>470 ms (women).
- Has a resting heart rate outside of the range of 45 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes).
- Healthy Non-Japanese Adult Participants (Part C)
- Has undergone CSF collection within 30 days before check-in (Day -2).
- Has a known hypersensitivity to anesthesia or its derivatives used during CSF collection or to any medication used to prepare the area of lumbar puncture.
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04082481
Start Date
November 17 2021
End Date
April 29 2022
Last Update
November 26 2021
Active Locations (2)
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1
Parexel Internalional - Glendale
Glendale, California, United States, 91206
2
PRA Health Sciences - Salt Lake City
Millcreek, Utah, United States, 84124