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Trial record 33 of 913 for:    tablet | Japan

A Phase 1 Bioequivalence Study of TAK-438 OD Tablet

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ClinicalTrials.gov Identifier: NCT03808493
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the bioequivalence (BE) of single oral dose of TAK-438 OD 20 mg tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2) in Japanese healthy adult male participants.

Condition or disease Intervention/treatment Phase
Japanese Healthy Adult Male Drug: TAK-438 OD Drug: TAK-438 Phase 1

Detailed Description:

The drug being tested in this study is called TAK-438 OD tablet. TAK-438 OD tablet is being tested in Japanese healthy adult men. This study will evaluate bioequivalence of single oral dose of TAK-438 OD 20 mg tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2).

The study will enroll up to 144 participants in total (Study 1 + 2). In Study 1 and 2, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups;

Study 1:

  • TAK-438 OD 20 mg tablet without water (Period 1) + TAK-438 20 mg tablet with water (Period 2)
  • TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet without water (Period 2)

Study 2:

  • TAK-438 OD 20 mg tablet with water (Period 1) + TAK-438 20 mg tablet with water (Period 2)
  • TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet with water (Period 2)

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 11 days. Participants will make two visits to the clinic and be hospitalized for four days each in Periods 1 and 2.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : September 18, 2019
Estimated Study Completion Date : September 18, 2019

Arm Intervention/treatment
Experimental: Study 1, TAK-438 OD + TAK-438
One TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9).
Drug: TAK-438 OD
TAK-438 OD tablet

Drug: TAK-438
TAK-438 tablet

Experimental: Study 1, TAK-438 + TAK-438 OD
One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9).
Drug: TAK-438 OD
TAK-438 OD tablet

Drug: TAK-438
TAK-438 tablet

Experimental: Study 2, TAK-438 OD + TAK-438
One TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9).
Drug: TAK-438 OD
TAK-438 OD tablet

Drug: TAK-438
TAK-438 tablet

Experimental: Study 2, TAK-438 + TAK-438 OD
One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9).
Drug: TAK-438 OD
TAK-438 OD tablet

Drug: TAK-438
TAK-438 tablet




Primary Outcome Measures :
  1. AUClast: Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-438 Free Base (TAK-438F) [ Time Frame: Days 1 and 9 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  2. Cmax: Maximum Observed Concentration for TAK-438F [ Time Frame: Days 1 and 9 pre-dose and at multiple time points (up to 48 hours) post-dose ]

Secondary Outcome Measures :
  1. AUC∞: Area Under the Concentration-Time Curve from Time 0 to Infinity for TAK-438F [ Time Frame: Days 1 and 9 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  2. tmax: Time of First Occurrence of Cmax for TAK-438F [ Time Frame: Days 1 and 9 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  3. MRT∞,ev: Mean Residence Time after Extravascular Administration from Time 0 to Infinity for TAK-438F [ Time Frame: Days 1 and 9 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  4. λz: Terminal Disposition Phase Rate Constant for TAK-438F [ Time Frame: Days 1 and 9 pre-dose and at multiple time points (up to 48 hours) post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. In the opinion of the investigator or sub-investigator, 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, aged 20 to 60 years, inclusive, at the time of informed consent.
  4. The participant weighs at least 50 kg and has a body mass index (BMI) from 18.5 to 25.0 kg/m^2, inclusive at Screening.
  5. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the start of study drug administration in Period 1.
  6. The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at the Screening Visit and prior to the start of study drug administration in Period 1.

Exclusion Criteria:

  1. The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
  2. The participant has received TAK-438 in a previous clinical study or as a therapeutic agent.
  3. The participant is an immediate family member of or a study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
  4. The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate in the study or potentially confound its results.
  5. The participant has hypersensitivity to any component of TAK-438 OD tablet or TAK-438 tablet.
  6. The participant has a positive urine drug result for drugs of abuse at Screening.
  7. The participant has a history of drug or alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  8. The participant has taken any excluded medication, supplements, or food products during the specified time periods.
  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, esophageal reflux, peptic ulcer disease, erosive esophagitis), frequent (more than once per week) occurrence of heartburn, or any surgical intervention.
  10. The participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
  11. The participant has a positive test result for hepatitis B virus 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 drug administration in 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 drug administration in Period 1.
  15. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration in Period 1.
  16. The participant has a Screening or Check-in (Day -1) ECG that was abnormal (clinically significant).
  17. The participant has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limits of normal (ULN).
  18. The participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808493


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Japan
Sekino Clinical Pharmacology Clininc Recruiting
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03808493     History of Changes
Other Study ID Numbers: TAK-438ODT-1001
U1111-1225-5005 ( Other Identifier: WHO )
JapicCTI-194587 ( Registry Identifier: JapicCTI )
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No