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

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ClinicalTrials.gov Identifier: NCT02201056
Recruitment Status : Completed
First Posted : July 25, 2014
Results First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
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.

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-935 in Healthy Subjects
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Cohort 1: TAK-935 15 mg
TAK-935 15 mg solution, orally, once, on Day 1.
Drug: TAK-935
TAK-935 oral solution

Experimental: Cohort 2: TAK-935 50 mg
TAK-935 50 mg solution, orally, once, on Day 1.
Drug: TAK-935
TAK-935 oral solution

Experimental: Cohort 3: TAK-935 200 mg
TAK-935 200 mg solution, orally, once, on Day 1.
Drug: TAK-935
TAK-935 oral solution

Experimental: Cohort 4: TAK-935 600 mg
TAK-935 600 mg solution, orally, once, on Day 1.
Drug: TAK-935
TAK-935 oral solution

Experimental: Cohort 5: TAK-935 900 mg
TAK-935 900 mg solution, orally, once, on Day 1.
Drug: TAK-935
TAK-935 oral solution

Experimental: Cohort 6: TAK-935 1350 mg
TAK-935 1350 mg solution, orally, once, on Day 1.
Drug: TAK-935
TAK-935 oral solution

Placebo Comparator: Cohorts 1-6: Placebo
TAK-935 placebo-matching solution, orally, once, on Day 1.
Drug: Placebo
TAK-935 placebo-matching oral solution




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
  2. 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:

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

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): NCT02201056


Locations
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United States, Nebraska
Lincoln, Nebraska, United States
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02201056     History of Changes
Other Study ID Numbers: TAK-935_101
U111-1155-6022 ( Registry Identifier: WHO )
First Posted: July 25, 2014    Key Record Dates
Results First Posted: July 12, 2016
Last Update Posted: July 12, 2016
Last Verified: June 2016
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Pharmaceutical Solutions