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Trial record 49 of 914 for:    tablet | Japan

A Study to Evaluate the Bioequivalence and the Food Effect of TAK-438ASA Tablet

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ClinicalTrials.gov Identifier: NCT03456960
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purposes of this study are to evaluate bioequivalence between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 mg and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men (Study 2).

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

Detailed Description:

The drug under investigation in this study is called TAK-438ASA. TAK-438ASA is being tested in Japanese healthy adult men. This study consists of two studies to evaluate bioequivalence (Study 1) and the effects of food (Study 2). Study 1 (split into a Pilot phase and a Pivotal phase) will look at bioequivalence between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 mg and aspirin enteric-coated tablet 100 mg. Study 2 will look at the effects of food on the pharmacokinetics of TAK-438ASA tablet.

The study will enroll up to 440 participants in total (Study 1 + 2). For Study 1, 12 participants per group (24 participants in total) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups for the pilot study to estimate the sample size of Pivotal study. After pilot study, 202 participants as a maximum per group (404 participants in total) will be randomly assigned to one of the two treatment groups;

  • TAK-438ASA tablet (Period 1) + TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 2)
  • TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 1) + TAK-438ASA tablet (Period 2)

For Study 2, 6 participants per group (12 participants in total) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups;

  • TAK-438ASA tablet (Fasted condition) + TAK-438ASA tablet (Fed condition)
  • TAK-438ASA tablet (Fed condition) + TAK-438ASA tablet (Fasted condition)

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 18 days. Participants will make two visits to the clinic and be hospitalized for eight days in total.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-438ASA Tablet and Single Oral Dose of TAK-438 Tablet Plus Aspirin Enteric-Coated Tablet (Study 1) and the Food Effect of Single Oral Dose of TAK-438ASA Tablet (Study 2) in Healthy Adult Male Subjects
Actual Study Start Date : March 8, 2018
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin
One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a wash-out period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16).
Drug: TAK-438ASA
TAK-438ASA tablet

Drug: TAK-438
TAK-438 tablet

Drug: Aspirin
Aspirin enteric-coated tablet

Experimental: Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA
One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a wash-out period (Days 2 to 15), followed by, one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16).
Drug: TAK-438ASA
TAK-438ASA tablet

Drug: TAK-438
TAK-438 tablet

Drug: Aspirin
Aspirin enteric-coated tablet

Experimental: Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin
One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a wash-out period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16).
Drug: TAK-438ASA
TAK-438ASA tablet

Drug: TAK-438
TAK-438 tablet

Drug: Aspirin
Aspirin enteric-coated tablet

Experimental: Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA
One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a wash-out period (Days 2 to 15), followed by, one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16).
Drug: TAK-438ASA
TAK-438ASA tablet

Drug: TAK-438
TAK-438 tablet

Drug: Aspirin
Aspirin enteric-coated tablet

Experimental: Study 2,TAK-438ASA (Fasted + Fed condition)
One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 15), followed by one TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 2 in Study 2 (Day 16).
Drug: TAK-438ASA
TAK-438ASA tablet

Experimental: Study 2,TAK-438ASA (Fed + Fasted condition)
One TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in Study 2 (Day 16).
Drug: TAK-438ASA
TAK-438ASA tablet




Primary Outcome Measures :
  1. AUClast: Area under the Plasma Concentration-Time Curve from Time 0 to Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F) in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  2. Cmax: Maximum Observed Plasma Concentration for TAK-438F in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  3. AUClast for Unchanged Aspirin in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose ]
  4. Cmax for Unchanged Aspirin in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose ]

Secondary Outcome Measures :
  1. AUC(infinity): Area under the Plasma Concentration-Time Curve from Time 0 to Infinity for TAK-438F in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  2. Tmax: Time to Reach Cmax for TAK-438F in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  3. MRT(infinity,ev): Mean Residence Time from Time 0 to Infinity for TAK-438F in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  4. λz: Apparent Terminal Elimination Rate Constant for TAK-438F in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  5. AUC(infinity) for Unchanged Aspirin in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose ]
  6. Tmax for Unchanged Aspirin in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose ]
  7. MRT(infinity,ev) for Unchanged Aspirin in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose ]
  8. λz for Unchanged Aspirin in Study 1 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose ]
  9. AUC(infinity) for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  10. AUCt: Area under the Plasma Concentration-Time Curve from Time 0 to Time t over the Dosing Interval for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  11. AUClast for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  12. Cmax for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  13. Tmax for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  14. T1/2z: Apparent Terminal Elimination Half-Life for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  15. AUC(infinity) for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  16. AUCt for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  17. AUClast for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  18. Cmax for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  19. Tmax for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  20. T1/2z for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  21. Aet: Amount of Unchanged Drug Excreted into Urine from Time 0 to Time t for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  22. Fe,t: Cumulative Percentage of Dose Excreted into Urine from Time 0 to Time t for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 48 hours) post-dose ]
  23. Renal Clearance (CLR) for TAK-438F and its Metabolites M-I, M-II, M-III and M-IV-Sul in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  24. Aet for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  25. Fe,t for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose ]
  26. CLR for Unchanged Aspirin and its Metabolites (Salicylic Acid) in Study 2 [ Time Frame: Pre-dose on Day 1 and at multiple time points (up to 24 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, participants are capable of understanding the procedures required for the study and complying with its requirements
  2. Participants sign and date an informed consent form by themselves prior to the initiation of any study procedures
  3. Japanese healthy men aged >= 20 and =< 60, inclusive, at the time of consent
  4. Body weight >= 50 kg as well as body mass index (BMI) >= 18.5 kg/m^2 and =< 25.0 kg/m^2 at screening test.

Exclusion Criteria:

  1. Participants who received study drug within 16 weeks (112 days) prior to the start of study treatment in Period 1
  2. Participants who received TAK-438 or aspirin in a previous study
  3. Staffs at the study site and their family, or participants who depend on the study-related staffs at the study site (e.g., husband and wife, parents, children, brothers and sisters), or participants who may be constrained to consent to the study
  4. Participants with uncontrolled and clinically significant neurological, cardiovascular, lung, hepatic, renal, metabolic, gastrointestinal, urinary or endocrine disease, or other abnormalities (except for diseases investigated) that might affect the study participation or impact the results of the study
  5. Participants with a previous or current history of aspirin asthma (asthmatic attack induced by non-steroidal anti-inflammatory drugs, etc.)
  6. Participants with hypersensitivity for components of TAK-438 tablet or aspirin enteric-coated tablet, or salicylic acid-based products
  7. Positive result in urinary test for illegal drug abuse at screening
  8. Participants who have a history of illegal drug abuse or alcoholism within the past 2 years prior to the screening visit, or who are not willing to refrain from alcohol consumption and drug use during the study period
  9. Participants who ingested a medicine, a supplement or food forbidden to be used in combination during the specified time period.
  10. Participants with a current history or recent episodes (within the past 6 months) of gastrointestinal diseases (malabsorption, gastroesophageal reflux, peptic ulcer disease, erosive oesophagitis), frequent (at least once per week) heartburn or surgical intervention that might affect drug absorption
  11. Participants with a history of cancer, except for basal cell carcinoma in remission for >= 5 years prior to Day 1
  12. Positive results at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological test for syphilis
  13. Participants who have difficulties in blood draw from peripheral veins
  14. Participants who had >= 200 mL of whole blood drawn within 4 weeks (28 days) prior to the start of study treatment in Period 1 or who had >= 400 mL of whole blood drawn within 12 weeks (84 days) prior to the start of study treatment in Period 1
  15. Participants who had a total of >= 800 mL of whole blood drawn within 52 weeks (364 days) prior to the start of study treatment in Period 1
  16. Participants who had blood components drawn within 2 weeks (14 days) prior to the start of study treatment in Period 1
  17. Clinically significant abnormalities in electrocardiogram at screening or admission (Day -1)
  18. Participants with abnormal laboratory parameters suggestive of clinically significant underlying diseases or who have abnormal values in the following measures at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) over the upper limit of normal
  19. Participants who are unlikely to comply with the protocol or deemed ineligible due to other reasons by the principal investigator or other investigators.

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): NCT03456960


Locations
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Japan
Fukuoka Mirai Hospital
Fukuoka, 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: NCT03456960     History of Changes
Other Study ID Numbers: TAK-438ASA-1001
U1111-1208-7631 ( Other Identifier: WHO )
JapicCTI-183885 ( Registry Identifier: JapicCTI )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics