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A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants

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ClinicalTrials.gov Identifier: NCT02541669
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to assess the pharmacokinetics and safety of single- and multiple-dose of TAK-491 in healthy Chinese participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: TAK-491 Drug: TAK-491 placebo Phase 1

Detailed Description:

The drug being tested in this study is called TAK-491. TAK-491 is being tested to treat people who have hypertension. This study will look at the pharmacokinetics of TAK-491 in Chinese participants who take TAK-491.

The study will enroll approximately 64 participants.

The first 16 enrolled participants have been randomly assigned (by chance, like flipping a coin) to 1 of the 2 treatment groups:

  • TAK-491 40 mg
  • TAK-491 80 mg

All participants will be asked to take 1 tablet at the same time on Day 1 and Day 4 to 10 during the study.

The following 48 randomized participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 3 treatment groups:

  • TAK-491 40 mg
  • TAK-491 80 mg
  • TAK-491 placebo

All participants will be asked to take two tablets at the same time on Day 1 and Day 4 to 10 during the study.

This single-center trial will be conducted in China. The overall time to participate in this study is approximately 52 days. Participants will be admitted in the clinic for the first 12 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Open-Label and Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Phase 1 Study of the Pharmacokinetics of TAK-491 40 mg and 80 mg in Healthy Chinese Subjects
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : March 17, 2017
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAK-491 40 mg (Open Label)
TAK-491 40 milligram (mg), tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
Drug: TAK-491
TAK-491 tablets
Other Names:
  • Azilsartan medoxomil
  • Edarbi

Experimental: TAK-491 80 mg (Open-label)
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
Drug: TAK-491
TAK-491 tablets
Other Names:
  • Azilsartan medoxomil
  • Edarbi

Experimental: TAK-491 40 mg (Double-blind)
TAK-491 40 mg, tablet, orally, once daily and TAK-491 80 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 in double-blind manner.
Drug: TAK-491
TAK-491 tablets
Other Names:
  • Azilsartan medoxomil
  • Edarbi

Drug: TAK-491 placebo
TAK-491 placebo-matching tablets

Experimental: TAK-491 80 mg (Double-blind)
TAK-491 80 mg, tablet, orally, once daily and TAK-491 40 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 in double-blind manner.
Drug: TAK-491
TAK-491 tablets
Other Names:
  • Azilsartan medoxomil
  • Edarbi

Drug: TAK-491 placebo
TAK-491 placebo-matching tablets

Placebo Comparator: Placebo
TAK-491 40 mg placebo-matching tablet, orally, once daily and TAK-491 80 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10.
Drug: TAK-491 placebo
TAK-491 placebo-matching tablets




Primary Outcome Measures :
  1. Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  2. Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10 [ Time Frame: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  3. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  4. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10 [ Time Frame: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  5. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]
  6. AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10 [ Time Frame: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose ]
  7. Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is capable of understanding and complying with protocol requirements.
  2. The participant or, when applicable, the legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. Is a healthy adult male or female of Chinese descent.
  4. Is aged 18 to 45 years, inclusive, at the time of informed consent and first study medication dose.
  5. Has a body mass index (BMI) greater than or equal to (>=) 19.0 kilogram per square meter (kg/m^2) and less than (<) 24.0 kg/m^2, inclusive at Screening.
  6. Has clinical laboratory evaluations (including clinical chemistry [fasted for at least 8 hours for the screening assessment], hematology, and complete urinalysis) within the reference range for the testing laboratory, unless the results were deemed by the investigator to be not clinically significant at Screening and Check-in (Day -1).
  7. Is willing to refrain from strenuous exercise, from 72 hours before Check-in (Day-1) until after Final Visit.
  8. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

  1. Has received any investigational compound within 30 days prior to Screening.
  2. Has received TAK-491 in a previous clinical study or as a therapeutic agent.
  3. Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
  4. Has history of uncontrolled, clinically significant manifestations of metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), endocrine, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, skin and subcutaneous tissue disorders, infectious, hepatic, renal, urologic, immunologic, psychiatric or mood disorders (including any past history of suicide attempt), or a history of lactose intolerance, which may impact the ability of the participant to participate or potentially confound the study results.
  5. Has a known hypersensitivity to any component of the formulation of TAK-491 or other AII inhibitors or related compounds.
  6. Has a positive urine drug result for drugs of abuse or breath alcohol test at Screening or Check-in (Day -1).
  7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  8. Has taken any excluded medication, supplements, or food products.
  9. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
  10. Has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (that is, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once per week] occurrence of heartburn, or any surgical intervention [example, cholecystectomy]).
  11. Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
  12. Has positive test result for anti-Human immunodeficiency virus (HIV), anti- hepatitis C virus (HCV) antibodies, or for hepatitis B surface antigen (HBsAg) at Screening.
  13. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).
  14. Has poor peripheral venous access.
  15. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
  16. Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participants with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator.
  17. Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>) 1.5 times the upper limits of normal.
  18. Has a hemoglobin value <12 gram per deciliter (g/dL) at Screening.
  19. Has a systolic blood pressure <110 and >=160 millimeter of Mercury (mmHg) or a diastolic blood pressure <60 and >=100 mmHg at Screening or Check-in (Day -1).

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): NCT02541669


Locations
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China, Beijing,P.R.
Beijing, Beijing,P.R., China
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] August 5, 2016
Statistical Analysis Plan  [PDF] April 28, 2017

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02541669    
Other Study ID Numbers: TAK-491_112
U1111-1159-5559 ( Other Identifier: WHO )
First Posted: September 4, 2015    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Azilsartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action