Clinical trial NCT02201056: Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to Day 30
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
timeFrame: Day 1 to Day 14
measure: Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose
timeFrame: Day 1 to Day 14
measure: Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for TAK-935
timeFrame: Multiple time-points (Up to 96 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
timeFrame: Multiple time-points (Up to 96 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935
timeFrame: Multiple time-points (Up to 96 hours) post-dose
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: