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

NCT03456960 | Completed Phase 1 Results

• 3 other identifiers: TAK-438ASA-1001U1111-1208-7631JapicCTI-183885
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• 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)

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

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

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

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

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

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

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

Secondary Outcomes (26)

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

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

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

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

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

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

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

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

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

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

Study Arms (6)

Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin

EXPERIMENTAL

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

Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA

EXPERIMENTAL

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

Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin

EXPERIMENTAL

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

Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA

EXPERIMENTAL

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

Study 2,TAK-438ASA (Fasted + Fed condition)

EXPERIMENTAL

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

Study 2,TAK-438ASA (Fed + Fasted condition)

EXPERIMENTAL

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

TAK-438ASA DRUG

TAK-438ASA tablet.

Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA; Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin; Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA; Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin; Study 2,TAK-438ASA (Fasted + Fed condition); Study 2,TAK-438ASA (Fed + Fasted condition)

TAK-438 DRUG

TAK-438 tablet.

Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA; Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin; Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA; Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin

Aspirin DRUG

Aspirin enteric-coated tablet.

Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA; Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin; Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA; Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants sign and date an informed consent form by themselves prior to the initiation of any study procedures.
• Japanese healthy men aged greater than or equal to (\>=) 20 and less than or equal to (=\<) 60, inclusive, at the time of consent.
• 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.

You may not qualify if:

• Participants who received study drug within 16 weeks (112 days) prior to the start of study treatment in Period 1.
• Participants who received TAK-438 or aspirin in a previous study.
• 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.
• 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.
• Participants with a previous or current history of aspirin asthma (asthmatic attack induced by non-steroidal anti-inflammatory drugs, etc.).
• Participants with hypersensitivity for components of TAK-438 tablet or aspirin enteric-coated tablet, or salicylic acid-based products.
• Positive result in urinary test for illegal drug abuse at screening.
• 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.
• Participants who ingested a medicine, a supplement or food forbidden to be used in combination during the specified time period.
• 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.
• Participants with a history of cancer, except for basal cell carcinoma in remission for \>=5 years prior to Day 1.
• 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.
• Participants who have difficulties in blood draw from peripheral veins.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Fukuoka Mirai Hospital

Fukuoka, Japan

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: March 8, 2018
• Primary Completion: October 10, 2018
• Study Completion: October 12, 2018
• Last Updated: November 19, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)