A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet

Hypertension Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Food-Effect of Single Oral Dose Administration of TAK-536TCH Final Formulation Tablet in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348658
• Other study ID #: TAK-536TCH/CPH-004
• Secondary ID: U1111-1165-5595J
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2015
• Last updated: August 3, 2015
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This is a phase 1, randomized, open-label, crossover study to evaluate the food-effect of single oral dose administration of TAK-536TCH final formulation tablet in healthy adult male subjects

Description:

The purpose of this study is to evaluate the effect of food on the pharmacokinetics and safety of a single oral dose of TAK-536TCH under fasted and fed conditions in the morning in an open-label 2x2 crossover manner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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, or hydrochlorothiazide 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 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• TAK-536TCH
TAK-536TCH tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the concentration-time curve) of the analyte in plasma	Analyte: unchanged TAK-536 and its major metabolites (M-I and M-II), amlodipine and hydrochlorothiazide	Up to 120 hours after administration of study drug in each period	No
Secondary	Frequency of adverse events (AE)	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.	Up to 36 days	Yes