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CompletedNCT03456960Updated Nov 19, 2019Results posted

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

A Phase 1 interventional study of TAK-438ASA and TAK-438 in Healthy Volunteers, sponsored by Takeda. Completed at 1 site in Japan. Open to male participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by Takeda · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Male
01

Study summary

The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (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).

Read the 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.
02

Conditions studied

  • Healthy Volunteers

Keywords

  • Drug Therapy
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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 greater than or equal to (>=) 20 and less than or equal to (=\<) 60, inclusive, at the time of consent.
  4. Body weight >=50 kilogram (kg) as well as body mass index (BMI) >=18.5 kilogram per meter square (kg/m\^2) and =\<25.0 kg/m\^2 at screening test.

Exclusion criteria

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 (example, 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 milliliter (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.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
276 participants (actual)

Study arms

  • 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 washout 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 · Drug: TAK-438 · Drug: Aspirin

  • 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 washout 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 · Drug: TAK-438 · Drug: Aspirin

  • 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 washout 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 · Drug: TAK-438 · Drug: Aspirin

  • 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 washout 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 · Drug: TAK-438 · Drug: Aspirin

  • 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 washout 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

  • 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 washout 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

Interventions

  • DrugTAK-438ASA

    TAK-438ASA tablet.

  • DrugTAK-438

    TAK-438 tablet.

  • DrugAspirin

    Aspirin enteric-coated tablet.

05

What researchers measure

Primary outcomes

  1. Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  2. Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  3. Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin

    Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

  4. Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin

    Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

Secondary outcomes

  1. Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  2. Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  3. Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  4. Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  5. Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin

    Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

  6. Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin

    Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

  7. Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin

    Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

  8. Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin

    Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

  9. Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites (M) (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  10. Study 2, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to Time 48 Hours Over the Dosing Interval for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  11. Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  12. Study 2, Cmax: Maximum Observed Plasma Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  13. Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  14. Study 2, T1/2z: Terminal Disposition Phase Half-life for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  15. Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin and Its Metabolite (Salicylic Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  16. Study 2, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Over the Dosing Interval for Unchanged Aspirin and Its Metabolite (Salicylic Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  17. Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  18. Study 2, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  19. Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin and Its Metabolite (Salicylic Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  20. Study 2, T1/2z: Terminal Disposition Phase Half-life for Unchanged Aspirin and Its Metabolite (Salicylic Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  21. Study 2, Ae(0-48): Amount of Drug Excreted in Urine From Time 0 to 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  22. Study 2, Fe(0-48): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  23. Study 2, CLR: Renal Clearance for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)

    Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

  24. Study 2, Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  25. Study 2, Fe(0-24): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

  26. Study 2, CLR: Renal Clearance for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)

    Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

06

Results

Posted Nov 4, 2019

Participant flow

Participants took part in the study at 1 investigative site in Japan from 8 March 2018 to 12 October 2018.

Period 1 (1 Day)
Participant flow — Period 1 (1 Day)
MilestonePilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)
Started121212012066
Completed121212012066
Not completed000000
Washout Period (at Least 14 Days)
Participant flow — Washout Period (at Least 14 Days)
MilestonePilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)
Started121212012066
Completed121211911866
Not completed001200
Withdrew: Withdrawal by subject001200
Period 2 (1 Day)
Participant flow — Period 2 (1 Day)
MilestonePilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)
Started121211911866
Completed111211911766
Not completed100100
Withdrew: Adverse event100100

Outcome measures

PrimaryStudy 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · hour*nanogram per milliliter (h*ng/mL)
Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)
hour*nanogram per milliliter (h*ng/mL)Pilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)92.46 ± 32.12891.95 ± 31.431——
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0059 · 90% CI -0.0340 to 0.0458
PrimaryStudy 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · nanogram per milliliter (ng/mL)
Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F
nanogram per milliliter (ng/mL)Pilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F13.87 ± 5.094513.22 ± 5.0778——
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0508 · 90% CI -0.0079 to 0.1096
PrimaryStudy 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin
Time frame:
Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin
h*ng/mLPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin873.5 ± 220.94831.9 ± 350.69912.3 ± 327.58832.7 ± 323.46
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0546 · 90% CI -0.0941 to 0.2034
  • Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin · Lsm difference: 0.0912 · 90% CI 0.0399 to 0.1424
PrimaryStudy 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin
Time frame:
Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Reported as:
Geometric mean · ng/mL
Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin
ng/mLPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin647.6 ± 326.77597.5 ± 507.90701.8 ± 349.18558.0 ± 404.26
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0916 · 90% CI -0.1330 to 0.3162
  • Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin · Lsm difference: 0.2293 · 90% CI 0.1519 to 0.3068
SecondaryStudy 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F
h*ng/mLPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F94.71 ± 32.33493.78 ± 31.828——
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0100 · 90% CI -0.0299 to 0.0500
SecondaryStudy 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Median · hour
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F
hourPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F1.500 (1.00 to 3.00)1.500 (1.00 to 3.00)——
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: -0.0281 · 90% CI -0.1662 to 0.1100
SecondaryStudy 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · hour
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F
hourPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F9.610 ± 1.24409.751 ± 1.3853——
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: -0.0150 · 90% CI -0.0448 to 0.0149
SecondaryStudy 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · 1 per hour
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F
1 per hourPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F0.08565 ± 0.00902300.08788 ± 0.013025——
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: -0.0195 · 90% CI -0.0676 to 0.0286
SecondaryStudy 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin
Time frame:
Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin
h*ng/mLPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin876.5 ± 221.10834.6 ± 349.28915.8 ± 328.82855.4 ± 322.27
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0547 · 90% CI -0.0937 to 0.2032
  • Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin · Lsm difference: 0.0654 · 90% CI 0.0141 to 0.1167
SecondaryStudy 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin
Time frame:
Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Reported as:
Median · hour
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin
hourPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin4.000 (2.50 to 8.50)4.500 (3.00 to 8.50)4.000 (2.00 to 11.0)4.500 (1.00 to 12.0)
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: -0.1460 · 90% CI -0.2478 to -0.0443
  • Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin · Lsm difference: -0.1674 · 90% CI -0.2084 to -0.1264
SecondaryStudy 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin
Time frame:
Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Reported as:
Mean · hour
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin
hourPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin4.629 ± 1.46345.194 ± 1.51544.398 ± 1.05525.152 ± 2.0334
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: -0.1193 · 90% CI -0.2179 to -0.0206
  • Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin · Lsm difference: -0.1366 · 90% CI -0.1730 to -0.1002
SecondaryStudy 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin
Time frame:
Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Reported as:
Mean · 1 per hour
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin
1 per hourPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and Aspirin
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin1.734 ± 0.303981.703 ± 0.307651.754 ± 0.322241.795 ± 0.35228
Statistical analysis
  • Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin · Lsm difference: 0.0148 · 90% CI -0.0734 to 0.1030
  • Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin · Lsm difference: -0.0020 · 90% CI -0.0463 to 0.0424
SecondaryStudy 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites (M) (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites (M) (M-I, M-II, M-III and M-IV-Sul)
h*ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-430ASA Fed
TAK-438F84.26 ± 16.890104.3 ± 19.470
M-I290.4 ± 50.706266.9 ± 44.125
M-II50.77 ± 19.17558.29 ± 63.088
M-III83.59 ± 15.20280.25 ± 22.318
M-IV-Sul115.9 ± 37.93397.60 ± 40.882
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-430ASA Fed · Lsm difference: 0.2138 · 90% CI 0.1609 to 0.2667
SecondaryStudy 2, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to Time 48 Hours Over the Dosing Interval for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 2, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to Time 48 Hours Over the Dosing Interval for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
h*ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-430ASA Fed
TAK-438F82.89 ± 16.467102.9 ± 18.851
M-I272.1 ± 49.341251.9 ± 44.461
M-II30.80 ± 14.80824.17 ± 12.927
M-III82.96 ± 14.93179.69 ± 22.117
M-IV-Sul111.5 ± 38.37693.20 ± 41.338
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-430ASA Fed · Lsm difference: 0.2161 · 90% CI 0.1652 to 0.2671
SecondaryStudy 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
h*ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F82.23 ± 16.775102.4 ± 19.138
M-I258.6 ± 49.384239.5 ± 44.950
M-II26.86 ± 12.92120.66 ± 10.882
M-III81.92 ± 15.03278.69 ± 21.959
M-IV-Sul108.4 ± 36.88489.48 ± 39.843
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.2190 · 90% CI 0.1675 to 0.2706
SecondaryStudy 2, Cmax: Maximum Observed Plasma Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Geometric mean · ng/mL
Study 2, Cmax: Maximum Observed Plasma Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F12.73 ± 2.546518.35 ± 5.4137
M-I41.26 ± 9.026135.22 ± 9.6886
M-II2.820 ± 0.838152.131 ± 0.57491
M-III15.38 ± 2.707814.90 ± 2.2273
M-IV-Sul28.52 ± 7.863423.09 ± 7.4466
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.3653 · 90% CI 0.2180 to 0.5126
SecondaryStudy 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Median · hour
Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
hourStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F1.500 (1.00 to 2.00)1.500 (1.00 to 3.00)
M-I1.500 (1.00 to 1.50)1.500 (1.00 to 4.00)
M-II4.000 (3.00 to 4.00)4.000 (4.00 to 10.0)
M-III1.750 (1.00 to 2.00)2.000 (1.00 to 4.00)
M-IV-Sul1.500 (1.00 to 3.00)2.000 (1.50 to 4.00)
SecondaryStudy 2, T1/2z: Terminal Disposition Phase Half-life for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · hour
Study 2, T1/2z: Terminal Disposition Phase Half-life for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
hourStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F8.293 ± 1.12547.951 ± 0.82489
M-I9.653 ± 1.35919.153 ± 1.0688
M-II12.92 ± 10.02927.52 ± 38.721
M-III6.797 ± 2.10596.826 ± 1.5924
M-IV-Sul4.067 ± 1.41944.543 ± 1.6209
SecondaryStudy 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
h*ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin817.9 ± 296.131008 ± 221.75
Salicylic acid20010 ± 5299.320290 ± 5048.4
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.2089 · 90% CI -0.0061 to 0.4239
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.0140 · 90% CI -0.0639 to 0.0918
SecondaryStudy 2, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Over the Dosing Interval for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 2, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Over the Dosing Interval for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
h*ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin816.7 ± 295.551007 ± 222.08
Salicylic acid20070 ± 5318.820340 ± 5119.5
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.2099 · 90% CI -0.0048 to 0.4246
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.0137 · 90% CI -0.0712 to 0.0986
SecondaryStudy 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Geometric mean · h*ng/mL
Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
h*ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin816.5 ± 295.681007 ± 222.45
Salicylic acid19370 ± 5108.519760 ± 4853.5
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.2096 · 90% CI -0.0054 to 0.4246
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.0201 · 90% CI -0.0690 to 0.1092
SecondaryStudy 2, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Geometric mean · ng/mL
Study 2, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
ng/mLStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin632.5 ± 286.18949.0 ± 415.75
Salicylic acid4414 ± 930.765374 ± 1119.4
Statistical analysis
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.4058 · 90% CI 0.0803 to 0.7312
  • Study 2: TAK-438ASA Fasted vs Study 2: TAK-438ASA Fed · Lsm difference: 0.1969 · 90% CI 0.1065 to 0.2873
SecondaryStudy 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Median · hour
Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
hourStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin4.500 (2.00 to 6.00)4.000 (2.50 to 7.00)
Salicylic acid5.500 (3.50 to 6.50)4.500 (3.00 to 8.00)
SecondaryStudy 2, T1/2z: Terminal Disposition Phase Half-life for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Mean · hour
Study 2, T1/2z: Terminal Disposition Phase Half-life for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
hourStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin0.3749 ± 0.0427840.4373 ± 0.10311
Salicylic acid2.050 ± 0.329821.901 ± 0.26555
SecondaryStudy 2, Ae(0-48): Amount of Drug Excreted in Urine From Time 0 to 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · microgram (mcg)
Study 2, Ae(0-48): Amount of Drug Excreted in Urine From Time 0 to 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
microgram (mcg)Study 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F433.3 ± 63.305583.1 ± 110.83
M-I150.1 ± 99.765153.4 ± 61.628
M-II0.000 ± 0.00000.000 ± 0.0000
M-III0.000 ± 0.00000.000 ± 0.0000
M-IV-Sul237.0 ± 56.783196.8 ± 59.876
SecondaryStudy 2, Fe(0-48): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · percentage of dose
Study 2, Fe(0-48): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
percentage of doseStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F4.333 ± 0.633055.831 ± 1.1083
M-I1.499 ± 0.995511.529 ± 0.61494
M-II0.000 ± 0.00000.000 ± 0.0000
M-III0.000 ± 0.00000.000 ± 0.0000
M-IV-Sul1.854 ± 0.443531.539 ± 0.46709
SecondaryStudy 2, CLR: Renal Clearance for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · liter per hour (l/h)
Study 2, CLR: Renal Clearance for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
liter per hour (l/h)Study 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
TAK-438F5.213 ± 0.657605.604 ± 0.55389
M-I0.5577 ± 0.386950.6018 ± 0.21705
M-II0.000 ± 0.00000.000 ± 0.0000
M-III0.000 ± 0.00000.000 ± 0.0000
M-IV-Sul2.148 ± 0.590162.126 ± 0.66434
SecondaryStudy 2, Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Mean · mcg
Study 2, Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
mcgStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin481.3 ± 173.04817.3 ± 403.78
Salicylic acid2318 ± 1904.72076 ± 1159.4
Salicyluric acid80180 ± 9852.283800 ± 4019.7
SecondaryStudy 2, Fe(0-24): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Mean · percentage of dose
Study 2, Fe(0-24): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
percentage of doseStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin0.4813 ± 0.173040.8173 ± 0.40378
Salicylic acid3.025 ± 2.48342.708 ± 1.5127
Salicyluric acid74.02 ± 9.098477.34 ± 3.7218
SecondaryStudy 2, CLR: Renal Clearance for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Time frame:
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Reported as:
Mean · l/h
Study 2, CLR: Renal Clearance for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
l/hStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Unchanged aspirin0.6181 ± 0.289170.7818 ± 0.29682
Salicylic acid0.1135 ± 0.0835340.1022 ± 0.055826

Adverse events

Collected over Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 2 days after the last dose of study drug in Period 2 (Day 18). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pilot Study 1: TAK-438ASA0/24 (0%)0/24 (0%)1/24 (4.2%)
Pilot Study 1: TAK-438 and Aspirin0/23 (0%)0/23 (0%)0/23 (0%)
Pivotal Study 1: TAK-438ASA0/237 (0%)0/237 (0%)8/237 (3.4%)
Pivotal Study 1: TAK-438 and Aspirin0/239 (0%)0/239 (0%)3/239 (1.3%)
Study 2: TAK-438ASA Fasted0/12 (0%)0/12 (0%)1/12 (8.3%)
Study 2: TAK-438ASA Fed0/12 (0%)0/12 (0%)0/12 (0%)
Most frequent other events
Most frequent other events
EventPilot Study 1: TAK-438ASAPilot Study 1: TAK-438 and AspirinPivotal Study 1: TAK-438ASAPivotal Study 1: TAK-438 and AspirinStudy 2: TAK-438ASA FastedStudy 2: TAK-438ASA Fed
Upper respiratory tract infectionInfections and infestations1/240/230/2370/2391/120/12
PharyngitisInfections and infestations0/240/236/2372/2390/120/12
NasopharyngitisInfections and infestations0/240/232/2370/2390/120/12
Liver function test abnormalInvestigations0/240/230/2371/2390/120/12

Baseline characteristics

The safety analysis set was defined as all participants who received at least one dose of study drug.

Age, Customized
Age, Customized(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Less than (<) 20 years0000000
Between 20 and 60 years121212012066276
Greater than (>) 60 years0000000
Sex: Female, Male
Sex: Female, Male(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Female0000000
Male121212012066276
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Count of participants——————0
Region of Enrollment
Region of Enrollment(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Japan121212012066276
Consumption of caffeine
Consumption of caffeine(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Had caffeine consumption6523182155
Had no caffeine consumption679710245221
Consumption of alcohol
Consumption of alcohol(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Drank daily2013006
Drank a few times per week22990022
Drank a few times per month35726833154
Never drank5538403394
Smoking classification
Smoking classification(Participants)Pilot Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAPivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and AspirinPivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASAStudy 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)Total
Never smoked76817644178
Current smoker209121125
Ex-smoker3630321173
07

Study locations

1 site
  • Fukuoka Mirai Hospital
    Fukuoka, Japan
08

References and documents

Study documents

  • Study protocol · Feb 9, 2018
  • Statistical analysis plan · Jul 25, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com 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.

09

Registry details

Key details

Study ID
NCT03456960
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Mar 8, 2018
Primary completion
Oct 10, 2018
Completion
Oct 12, 2018
Results posted
Nov 4, 2019
Last update
Nov 19, 2019

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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