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Completed

NCT Number: NCT02201056

Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lincoln, Nebraska, United States

About this study

The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
  • Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive at the Screening Visit.

Exclusion criteria

  • Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
  • Has a known hypersensitivity to any component of the formulation of TAK-935.
  • There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.

Treatment and study plan

TAK-935

Drug

TAK-935 oral solution

Placebo

Drug

TAK-935 placebo-matching oral solution

Primary outcomes

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

    Time frame: Day 1 to Day 30

    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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.

  2. Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose

    Time frame: Day 1 to Day 14

    The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.

  3. Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose

    Time frame: Day 1 to Day 14

    The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.

  4. Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose

    Time frame: Day 1 to Day 14

    The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.

Secondary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for TAK-935

    Time frame: Multiple time-points (Up to 96 hours) post-dose

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

    Time frame: Multiple time-points (Up to 96 hours) post-dose

  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935

    Time frame: Multiple time-points (Up to 96 hours) post-dose

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2014
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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