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

NCT02541669 | Completed Phase 1 Results

• 2 other identifiers: TAK-491_112U1111-1159-5559
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (7)

• Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10

  Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10

  Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose

• 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

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• 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

  Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose

• Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1

  Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Study Arms (5)

TAK-491 40 mg (Open Label)

EXPERIMENTAL

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 80 mg (Open-label)

EXPERIMENTAL

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 40 mg (Double-blind)

EXPERIMENTAL

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; Drug: TAK-491 placebo

TAK-491 80 mg (Double-blind)

EXPERIMENTAL

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; Drug: TAK-491 placebo

Placebo

PLACEBO COMPARATOR

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

Interventions

TAK-491 DRUG

TAK-491 tablets

Also known as: Azilsartan medoxomil, Edarbi

TAK-491 40 mg (Double-blind); TAK-491 40 mg (Open Label); TAK-491 80 mg (Double-blind); TAK-491 80 mg (Open-label)

TAK-491 placebo DRUG

TAK-491 placebo-matching tablets

Placebo; TAK-491 40 mg (Double-blind); TAK-491 80 mg (Double-blind)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is capable of understanding and complying with protocol requirements.
• 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.
• Is a healthy adult male or female of Chinese descent.
• Is aged 18 to 45 years, inclusive, at the time of informed consent and first study medication dose.
• 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.
• 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).
• Is willing to refrain from strenuous exercise, from 72 hours before Check-in (Day-1) until after Final Visit.
• 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.

You may not qualify if:

• Has received any investigational compound within 30 days prior to Screening.
• Has received TAK-491 in a previous clinical study or as a therapeutic agent.
• 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.
• 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.
• Has a known hypersensitivity to any component of the formulation of TAK-491 or other AII inhibitors or related compounds.
• Has a positive urine drug result for drugs of abuse or breath alcohol test at Screening or Check-in (Day -1).
• 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.
• Has taken any excluded medication, supplements, or food products.
• 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.
• 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 \[example, cholecystectomy\]).
• Has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
• 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.
• 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).
• Has poor peripheral venous access.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Beijing, Beijing,P.R., China

Location

MeSH Terms

Interventions

azilsartan medoxomil; azilsartan

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: November 20, 2015
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

CN (1)