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Trial record 6 of 10 for:    TAK-935

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants

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ClinicalTrials.gov Identifier: NCT04461483
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: TAK-935 Drug: Placebo Phase 1

Detailed Description:

The drug being tested in this study is called TAK-935 tablet. TAK-935 tablet is being tested in Japanese healthy adult men. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).

The study will enroll up to 33 participants in total (Part 1 + 2). In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to one of these treatment cohorts/groups;

  • Cohort 1: Single dose of TAK-935 at 200 mg or placebo (fasted)
  • Cohort 2: Single dose of TAK-935 at 600 mg or placebo (fasted)
  • Cohort 3: Single dose of TAK-935 at 1200 mg or placebo (fasted)

In Part 2, participants will be randomly assigned to one of these treatment groups;

- Cohort 4: Multiple doses with titration of TAK-935 or placebo at 100 mg twice daily (BID) from Day 1 to Day 7, 200 mg BID from Day 8 to Day 14 and 300 mg BID from Day 15 to Day 21 (fasted).

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 36 days for Part 1 and 63 days for Part 2. Participants will be hospitalized for 5 days in Part 1 and 26 days in Part 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Subjects
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : November 14, 2020
Estimated Study Completion Date : November 14, 2020

Arm Intervention/treatment
Experimental: Part 1, Cohort 1; TAK-935 200 mg
Part 1, Cohort 1; TAK-935 200 mg, tablets, orally once on Days 1 in fasted state.
Drug: TAK-935
TAK-935 Tablets

Experimental: Part 1, Cohort 2; TAK-935 600 mg
Part 1, Cohort 2; TAK-935 600 mg, tablets, orally once on Days 1 in fasted state.
Drug: TAK-935
TAK-935 Tablets

Experimental: Part 1, Cohort 3; TAK-935 1200 mg
Part 1, Cohort 3; TAK-935 1200 mg, tablets, orally once on Days 1 in fasted state.
Drug: TAK-935
TAK-935 Tablets

Placebo Comparator: Part 1, Cohort 1-3; Placebo
Part 1, Cohort 1-3; TAK-935 placebo-matching tablets, orally once on Days 1 in fasted state.
Drug: Placebo
TAK-935 placebo-matching tablets

Experimental: Part 2, Cohort 4: TAK-935 100 mg
Part 2, Cohort 4: TAK-935 100 mg, tablets, orally twice on Days 1-7 in fasted state with multiple doses with titration.
Drug: TAK-935
TAK-935 Tablets

Experimental: Part 2, Cohort 4: TAK-935 200 mg
Part 2, Cohort 4: TAK-935 200 mg, tablets, orally twice on Days 8-14 in fasted state with multiple doses with titration.
Drug: TAK-935
TAK-935 Tablets

Experimental: Part 2, Cohort 4: TAK-935 300 mg
Part 2, Cohort 4: TAK-935 300 mg, tablets, orally twice on Days 15-21 in fasted state with multiple doses with titration.
Drug: TAK-935
TAK-935 Tablets

Placebo Comparator: Part 2, Cohort 4: Placebo
Part 2, Cohort 4: TAK-935 placebo-matching tablets, orally twice on Days 1-21 in fasted state.
Drug: Placebo
TAK-935 placebo-matching tablets




Primary Outcome Measures :
  1. Percentage of Participants who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Part 1: Up to Day 8, Part 2: Up to Day 35 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.


Secondary Outcome Measures :
  1. Cmax: Maximum Observed Plasma Concentration for TAK-935 [ Time Frame: Part 1: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose, Part 2: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose ]
  2. Area Under the Plasma Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration (AUClast) for TAK-935 (Part 1 only) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  3. Area Under the Plasma Concentration-time Curve from Time 0 to Time of Infinity (AUCinf) for TAK-935 (Part 1 only) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  4. AUC from Time 0 to 24 Hours (AUC24) for TAK-935 (Part 1 only) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose ]
  5. AUC during a Dosing Interval (AUCtau) at Steady State for TAK-935 (Part 2 only) [ Time Frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose ]


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.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The participant must understand the study procedures and agree to participate by providing written informed consent.
  2. The participant must be willing and able to comply with all study procedures and restrictions.
  3. The participant must be a Japanese healthy adult male or female, aged 20 to 55 years, inclusive, at the time of informed consent.
  4. The participant must have a body mass index (BMI) >=18.5 and =<25.0 kg/m^2 at the Screening Visit.
  5. The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the first dose of study drug or first invasive procedure.
  6. The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram, and vital sign measurements performed at the Screening Visit and prior to the first dose of study drug.
  7. The participant must meet the following birth control requirements:

    • Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until 90 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided the participant is at least 1-year postbilateral vasectomy procedure prior to the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year prior to the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedure should be provided.
    • Is a male participant who agrees to not donate sperm from the first dose of study drug until 90 days after the last dose of study drug.
    • Is a female participant of nonchildbearing potential, defined by at least 1 of the following criteria:

      1. Postmenopausal (defined as 12 months of spontaneous amenorrhea in females aged >45 years or >=6 months of spontaneous amenorrhea in females aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 mIU/mL). Appropriate documentation of follicle-stimulating hormone levels should be required.
      2. Hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
      3. Had a tubal ligation with appropriate documentation of surgical procedure.
      4. Congenital conditions such as uterine aplasia etc.

Exclusion Criteria:

  1. Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular (including arrhythmia), hematological, hepatic, immunological, renal, respiratory, genitourinary, major neurological (including stroke, epileptic seizure), or degenerative ophthalmological abnormalities or diseases
  2. Has participated in another investigational trial within 4 weeks or 5 half-lives (whichever is longer) before the pretrial visit (Screening). The 4-week or 5 half-lives window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
  3. Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the sponsor.
  4. Has a history of cancer (malignancy).
  5. Has any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within 12 months, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS) or is clinically judged by the investigator to be at risk for suicide.
  6. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
  7. Has a positive alcohol or drug screen.
  8. Had major surgery, donated or lost whole blood prior to the start of study drug administration as any of below:

    For both male and female participants, >=200 mL within 4 weeks (28 days) For male participants, >=400 mL within 12 weeks (84 days), >=800 mL in total within 52 weeks (364 days) For female participants, >=400 mL within 16 weeks (112 days). >=400 mL in total within 52 weeks (364 days)

  9. Had gastrointestinal surgery that could impact the absorption of study drug.
  10. Has a history of a major psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria.
  11. Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds.
  12. Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies, beginning approximately 7 days before administration of the initial dose of study drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit.
  13. 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.
  14. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  15. Has a substance abuse disorder.
  16. Has a QTcF >450 msec confirmed with one repeat testing, at the Screening Visit.
  17. Had abnormal Screening or Day -1 laboratory values that suggested a clinically significant underlying disease or participant with the following laboratory abnormalities: ALT and/or AST >1.5 time ULN.
  18. Has tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody/antigen, or serologic reactions for syphilis at Screening.
  19. In the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

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): NCT04461483


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
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Japan
Clinical Research Hospital Tokyo Recruiting
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04461483    
Other Study ID Numbers: TAK-935-1004
U1111-1252-8555 ( Other Identifier: WHO )
JapicCTI-205349 ( Registry Identifier: JapicCTI )
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No