A Phase I Bioequivalence Study of TAK-536 Pediatric Formulation

Japanese Healthy Adult Males Clinical Trial

Official title:

A Randomized, Open-label, 2×2 Crossover, Phase I Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-536 Pediatric Formulation and TAK-536 Commercial Tablet in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401464
• Other study ID #: TAK-536/CPH-101
• Secondary ID: U1111-1168-3113J
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2015
• Last updated: September 1, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: September 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

The purpose of this study is to assess the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation and a single oral dose of TAK-536 commercial tablet in healthy Japanese adult male subjects.

Description:

This study was designed to compare the bioequivalence of a single oral dose of 2 different drug forms of TAK-536 pediatric formulation (dry syrup, granules) and a single oral dose of TAK-536 commercial tablet by using open-label, 2 × 2 crossover design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2015
• Est. primary completion date: May 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 or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.

2. The participant signs and dates a written, ICF and any required privacy authorization prior to the initiation of any study procedures.

3. The participant is a healthy Japanese adult male volunteer. 4. The participant is between 20 and 35 years of age at the time of informed consent.

5. The participant has a body weight of at least 50.0 kg and has a body mass index (BMI) between 18.5 and 25.0 kg/m2 at the time of screening.

Exclusion Criteria:

• The participant has shown symptoms of dizziness on standing up, pallor facial, cold sweat, etc, and suspected hypotension at medical examination/physical findings at screening and the day before administration of the study drug for Period 1, and before administration of the study drug for Period 1.

2. The participant has received any investigational compound within 16weeks (112 days) prior to the start of study medication for Period 1 3. The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.

4. The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.

5. The participant has a known hypersensitivity to TAK-536 or angiotensin II receptor blockers.

6. The participant has positive results in the urine drug screening test at screening.

7. The 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 or is unwilling to agree to abstain from alcohol and drugs throughout the study period.

8. The participant has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table

9. The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, oesophageal reflux, peptic ulcer disease, erosive oesophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention (ie, cholecystectomy).

10. The participant has a history of cancer. 11. The participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening.

12. The participant has poor peripheral venous access. 13. The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study medication administration for Period 1.

14. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study medication administration for Period 1.

15. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration for Period 1.

16. The participant has an abnormal (clinically significant) electro-cardiogram at screening or prior to the start of study medication for Period 1.

17. The participant has abnormal laboratory values at screening or prior to the start of study medication for Period 1 that suggest a clinically significant underlying disease or participant with the following lab abnormalities: ALT or AST >1.5 times the upper limits of normal.

18. The participant who, in the opinion of the investigator or the sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Study Design

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

Related Conditions & MeSH terms

• Japanese Healthy Adult Males

Intervention

Drug:
• TAK-536
TAK-536 dry syrup formulation + TAK-536 10 mg tablet
• TAK-536
TAK-536 10 mg tablet + TAK-536 dry syrup formulation
• TAK-536
TAK-536 granule formulation + TAK-536 10 mg tablet
• TAK-536
TAK-536 10 mg tablet + TAK-536 granule formulation

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	Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for unchanged TAK-536	AUC(0-48) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 48 hours in this study).	Up to 48 hours	No
Primary	Maximum Observed Plasma Concentration for unchanged TAK-536	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	Up to 48 hours	No
Secondary	Number of participants who experience at least 1 treatment-emergent adverse event	An Adverse Event 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 6 Days	Yes