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

NCT04461483 | Completed Phase 1 Results

• 3 other identifiers: TAK-935-1004U1111-1252-8555JapicCTI-205349
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Parts 1 and 2: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

  Part 1: Baseline up to Day 8; Part 2: Baseline up to Day 35

Secondary Outcomes (6)

• Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-935

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

• Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-935

  Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose

• Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-935

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

• Part 1, AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for TAK-935

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

• Part 1, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-935

  Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Study Arms (8)

Part 1, Cohort 1; TAK-935 200 mg

EXPERIMENTAL

Part 1, Cohort 1; TAK-935 200 mg, tablets, orally once on Days 1 in fasted state.

Drug: TAK-935

Part 1, Cohort 2; TAK-935 600 mg

EXPERIMENTAL

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

Drug: TAK-935

Part 1, Cohort 3; TAK-935 1200 mg

EXPERIMENTAL

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

Drug: TAK-935

Part 1, Cohort 1-3; Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part 2, Cohort 4: TAK-935 100 mg

EXPERIMENTAL

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

Part 2, Cohort 4: TAK-935 200 mg

EXPERIMENTAL

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

Part 2, Cohort 4: TAK-935 300 mg

EXPERIMENTAL

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

Part 2, Cohort 4: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TAK-935 DRUG

TAK-935 Tablets

Part 1, Cohort 1; TAK-935 200 mg; Part 1, Cohort 2; TAK-935 600 mg; Part 1, Cohort 3; TAK-935 1200 mg; Part 2, Cohort 4: TAK-935 100 mg; Part 2, Cohort 4: TAK-935 200 mg; Part 2, Cohort 4: TAK-935 300 mg

Placebo DRUG

TAK-935 placebo-matching tablets

Part 1, Cohort 1-3; Placebo; Part 2, Cohort 4: Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The participant must understand the study procedures and agree to participate by providing written informed consent.
• The participant must be willing and able to comply with all study procedures and restrictions.
• The participant must be a Japanese healthy adult male or female, aged 20 to 55 years, inclusive, at the time of informed consent.
• The participant must have a body mass index (BMI) \>=18.5 and =\<25.0 kg/m\^2 at the Screening Visit.
• 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.
• 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.
• 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:
• 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.
• Hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
• Had a tubal ligation with appropriate documentation of surgical procedure.
• Congenital conditions such as uterine aplasia etc.

You may not qualify if:

• 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
• 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.
• Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the sponsor.
• Has a history of cancer (malignancy).
• 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.
• 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.
• Has a positive alcohol or drug screen.
• 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)
• Had gastrointestinal surgery that could impact the absorption of study drug.
• Has a history of a major psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria.
• Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Location

Results Point of Contact

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

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 8, 2020
• Study Start: August 13, 2020
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)