A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT2080222725
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 24
1. In the opinion of the investigator and subinvestigator, the participant is capable of understanding and complying with protocol requirements.
2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
3. The participant is a healthy Japanese adult male.
4. The participant is aged 20 to 35 years, inclusive at the time of informed consent.
5. The participant weighs at least 50.0 kg and has a body mass index (BMI) from 18.5 to 25.0 kg/m2, inclusive at Screening.
1. Participant has systolic blood pressure < 90 mmHg at Screening.
2. Participant has suspected hypotension and associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on Day -1 of Period 1, or up to administration on the Period 1.
3. The participant has received any study drug within 16 weeks (i.e., 112 days) prior to study drug administration of Period 1.
4. The participant has received TAK-491*, TAK-536, amlodipine (AML), or hydrochlorothiazide (HCTZ) in a previous clinical study or as a therapeutic agent.
*: A prodrug of TAK-536
5. Participant has a known hypersensitivity to drugs.
6. Participant requires any excluded medication, vitamins, or food products listed in the prohibited medications and foods table.
7. Participant has abnormal laboratory values at Screening or prior to study drug administration of Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: ALT or AST is >1.5-fold of the upper limits of normal range.
8. Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations and urinary excretion rates<br>Primary timeframe: 5 days<br>Pharmacokinetics of unchanged TAK-536 and its major metabolites (M-I and M-II), AML and HCTZ
- Secondary Outcome Measures
Name Time Method Frequency of adverse events (AE)<br>Secondary timeframe: Up to 36 days<br>The frequencies of all adverse events that occur after study drug administration will be tabulated. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.