Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155567
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of phenylacetate and benzoate after intravenous administration of TAK-123 in Japanese healthy adult male participants.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: TAK-123 Phase 1

Detailed Description:

The drug being tested in this study is called TAK-123. TAK-123 is being tested in Japanese healthy adult men. This study will look at the PK, safety and tolerability of phenylacetate and benzoates of people who administered TAK-123.

The study will enroll approximately 10 participants. All participants will be administered TAK-123 intravenously at the dose level of 3.75 g/m^2 of sodium phenylacetate and 3.75 g/m^2 of sodium benzoate.

- TAK-123 as 3.75 g/m^2 of sodium phenylacetate and 3.75 g/m^2 of sodium benzoate

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 8 days. Participants will make multiple visits to the clinic and be hospitalized for four days.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Subjects
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Arm Intervention/treatment
Experimental: TAK-123
TAK-123 as 3.75 gram per square meter (g/m^2) of sodium phenylacetate and 3.75 g/m^2 of sodium benzoate, intravenous administration over 90 minutes, followed by TAK-123 as 3.75 g/m^2 of sodium phenylacetate and 3.75 g/m^2 of sodium benzoate, intravenous administration over 24 hours.
Drug: TAK-123
TAK-123 infusion




Primary Outcome Measures :
  1. Cmax: Maximum Observed Concentration (Measured Values) for Phenylacetate, Benzoate, and These Metabolites (Phenylacetylglutamine and Hippurate) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  2. AUClast: Area under the Plasma Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Phenylacetate, Benzoate, and These Metabolites (Phenylacetylglutamine and Hippurate) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  3. AUC∞: Area under the Plasma Concentration-time Curve from Time 0 to Infinity for Phenylacetate, Benzoate, and These Metabolites (Phenylacetylglutamine and Hippurate) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]

Secondary Outcome Measures :
  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 8 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. A TEAE is defined as an AE that occurs on or after the start of the study drug administration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The participant is capable of understanding and complying with protocol requirements in the opinion of the investigator or sub-investigator.
  2. The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
  3. The participant is a Japanese healthy adult male.
  4. The participant is aged 20 to 45 years inclusive at the time of informed consent.
  5. The participant weighs at least 50.0 kg, and has a body mass index (BMI) between 18.5 and 25.0 kg/m^2, inclusive, at Screening.
  6. The participant is sterile, vasectomized or agrees to use an appropriate method of contraception throughout the treatment period.

Exclusion Criteria:

  1. The participant has received any investigational drugs within 90 days before screening for this study (including the cases that at least 5 times the elimination half-lives of any investigational drugs have not yet passed).
  2. The participant previously received TAK-123, its ingredients, or related compound before participation in this study except for the cases where benzoic acid is ingested as a food additive.
  3. The participant is an employee of the study site, or immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or who may be coerced to provide consent.
  4. The participants have previous or current history of diseases that may affect the participation in this study or study results, including uncontrolled, clinically relevant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine, hematologic, immune, skin disease or psychiatric disorder.
  5. The participant has a history of multiple episodes or severe allergies (example, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription drugs, over-the-counter (OTC) drugs or foods.
  6. The participant has had an anaphylactic reaction to active ingredients or additives of TAK-123, ondansetron or additives of ondansetron, or salicylic acid associated with the intravenous administration of TAK-123.
  7. The participant has a positive urine drug test at the time of screening.
  8. The participant has a history of drug abuse (defined as any illicit drug use) or has a history of alcohol dependence within 2 years before the start of screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
  9. The participant consumes 6 or more servings of caffeinated beverages (containing about 720 mg of caffeine or more) such as coffee, tea, cola, or energy drinks per day.
  10. The participant is a smoker who smoked cigarettes or used nicotine-containing products (such as nicotine patch) within 6 months before the study drug administration.
  11. The participant has a history of cancer.
  12. The participant has a positive test result for any of the following at the time of screening: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, serological test for syphilis.
  13. The participant has poor peripheral venous access.
  14. The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of the study drug administration.
  15. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of the study drug administration.
  16. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration.
  17. The participant has any clinically relevant abnormality in vital signs or 12-lead electrocardiogram (ECG) at screening or predose of Day 1.
  18. The participant has abnormal laboratory test values at screening indicating clinically relevant underlying disease, or showing alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 × upper limit of normal (ULN).
  19. The participant has been on an abnormal diet (example, excessive drinking and eating or starvation condition) during the four weeks (28 days) prior to the start of the study drug administration in the opinion of the investigator or sub-investigator.
  20. The participant who used or plans to use excluded concomitant medications, supplements, or dietary products during the predefined period in this study.
  21. The participant is unlikely to comply with the protocol requirements or is unsuitable as a participant of this study for any other reason in the opinion of the investigator or sub-investigator.

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): NCT04155567


Locations
Layout table for location information
Japan
Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04155567    
Other Study ID Numbers: TAK-123-1001
U1111-1237-4920 ( Other Identifier: WHO )
JapicCTI-195027 ( Registry Identifier: JapicCTI )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes