TAK-935 Multiple Rising Dose Study in Healthy Participants

NCT02539134 | Completed Phase 1 Results

• 2 other identifiers: TAK-935-1002U1111-1168-6634
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.

Conditions

Epilepsy

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)

  Day 1 up to Day 28

• Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose

  Baseline up to Day 15

• Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose

  Baseline up to Day 15

• Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose

  Baseline up to Day 15

Secondary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for TAK-935

  Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose

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

  Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935

  Day 1: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose

• AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Over the Dosing Interval for TAK-935

  Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose

Study Arms (7)

Part 1, Cohort 1: TAK-935 100 mg QD

EXPERIMENTAL

TAK-935 100 milligram (mg), solution, orally, once daily (QD) or TAK-935 placebo-matching solution, orally, QD for up to 14 days.

Drug: TAK-935; Drug: Placebo

Part 1, Cohort 2: TAK-935 300 mg QD

EXPERIMENTAL

TAK-935 300 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days.

Drug: TAK-935; Drug: Placebo

Part 1, Cohort 3: TAK-935 300 mg BID

EXPERIMENTAL

TAK-935 300 mg, solution, orally, twice daily (BID) or TAK-935 placebo-matching solution, orally, BID for up to 10 days.

Drug: TAK-935; Drug: Placebo

Part 1, Cohort 4: TAK-935 600 mg QD

EXPERIMENTAL

TAK-935 600 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 10 days.

Drug: TAK-935; Drug: Placebo

Part 1, Cohort 5: TAK-935 400 mg QD

EXPERIMENTAL

TAK-935 400 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days.

Drug: TAK-935; Drug: Placebo

Part 2, Cohort 6: TAK-935 Dose 1

EXPERIMENTAL

TAK-935 first decided dose as determined from other TAK-935 trials and Cohorts 1 to 4 of Part 1, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days.

Drug: TAK-935; Drug: Placebo

Part 2, Cohort 7: TAK-935 Dose 2

EXPERIMENTAL

TAK-935 second decided dose as determined from other TAK-935 trials and Cohorts 1 to 4 of Part 1, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days.

Drug: TAK-935; Drug: Placebo

Interventions

TAK-935 DRUG

TAK-935 oral solution

Part 1, Cohort 1: TAK-935 100 mg QD; Part 1, Cohort 2: TAK-935 300 mg QD; Part 1, Cohort 3: TAK-935 300 mg BID; Part 1, Cohort 4: TAK-935 600 mg QD; Part 1, Cohort 5: TAK-935 400 mg QD; Part 2, Cohort 6: TAK-935 Dose 1; Part 2, Cohort 7: TAK-935 Dose 2

Placebo DRUG

TAK-935 placebo-matching oral solution

Part 1, Cohort 1: TAK-935 100 mg QD; Part 1, Cohort 2: TAK-935 300 mg QD; Part 1, Cohort 3: TAK-935 300 mg BID; Part 1, Cohort 4: TAK-935 600 mg QD; Part 1, Cohort 5: TAK-935 400 mg QD; Part 2, Cohort 6: TAK-935 Dose 1; Part 2, Cohort 7: TAK-935 Dose 2

Eligibility Criteria

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

You may qualify if:

• All Cohorts
• Is capable of understanding and complying with protocol requirements.
• Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
• Is a healthy male or female aged 18 to 55 years inclusive, at the time of informed consent and first study medication dose.
• Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m\^2), inclusive at Screening and Day -1.
• Male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
• Female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent and throughout the duration of the study, and for 30 days after the last dose.
• Can complete the CogState Battery at Screening.
• Agrees to spinal tap procedures for CSF collection.

You may not qualify if:

• All Cohorts
• Has received any investigational compound within 30 days prior to randomization.
• Has received TAK-935 in a previous clinical study or as a therapeutic agent.
• Has a significant history of uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease or psychiatric disorder or endocrine disease or other abnormality or any significant results from physical examinations, or clinical laboratory results which may impact the ability of the participant to participate or potentially confound the study results. It is the responsibility of the investigator to assess the clinical significance; however, consultation with the Takeda Medical Monitor may be warranted.
• Has a known hypersensitivity to any component of the formulation of TAK-935.
• 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. One unit is equivalent to a half-pint of beer or a single measure of spirits or 1 small glass of wine.
• Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.
• Has CSF collection performed within 30 days prior to check-in (Day -3).
• Has a known hypersensitivity to the anesthetic or its derivatives used during CSF collection, or any medication used to prepare the area of lumbar puncture.
• Has significant vertebral deformities (scoliosis or kyphosis) which, in the opinion of the investigator, may interfere with lumbar puncture procedure.
• Has a history of clinically significant back pain and/or injury.
• Has local infection at the puncture site.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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: August 31, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-04

Locations

US (1)