Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
82 participants
INTERVENTIONAL
2014-11-30
2015-04-30
Brief Summary
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Detailed Description
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The study is composed of three parts, Single-dose Ascending Part, Food Effect Part and Multiple-dose Ascending Part. Single-dose Ascending Part and Multiple-dose Ascending Part are designed as a randomized, double-blind or open-label, placebo-controlled, sequential-cohort, ascending single or multiple oral dose study of TAK-114 or matched placebo. The Food Effect Part is designed as a randomized, open-label, 2-period crossover study of a single dose of TAK-114.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1A: TAK-114 10 mg
Orally, once only.
TAK-114 10 mg capsule
Cohort 1B: TAK-114 10 mg
Orally, once
TAK-114 10 mg capsule
Cohort 2A: TAK-114 20 mg
Orally, once
TAK-114 10 mg capsule
Cohort 2B: TAK-114 20 mg
Orally, once
TAK-114 10 mg capsule
Cohort 3A: TAK-114 50 mg
Orally, once
TAK-114 10 mg capsule
Cohort 3B: TAK-114 50 mg
Orally, once
TAK-114 10 mg capsule
Cohort 4a: TAK-114 20 mg
Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast
TAK-114 10 mg capsule
Cohort 4b: TAK-114 20 mg
Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state
TAK-114 10 mg capsule
Cohort 5A: TAK-114 20 mg
Orally, Twice daily, 10 days
TAK-114 10 mg capsule
Cohort 5B: TAK-114 20 mg
Orally, Twice daily, 10 days
TAK-114 10 mg capsule
Cohort 6A: TAK-114 50 mg
Orally, Twice daily, 10 days
TAK-114 10 mg capsule
Cohort 6B: TAK-114 50 mg
Orally, Twice daily, 10 days
TAK-114 10 mg capsule
Cohort 1A, 2A, 3A: TAK-114 placebo
Cohort 1A, 2A, 3A: Orally, once
TAK-114 matched placebo
Cohort 5A: TAK-114 placebo
Cohort 5A: Orally, Twice daily, 10 days
TAK-114 matched placebo
Cohort 6A: TAK-114 placebo
Cohort 6A: Orally, Twice daily, 10 days
TAK-114 matched placebo
Interventions
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TAK-114 10 mg capsule
TAK-114 matched placebo
Eligibility Criteria
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Inclusion Criteria
* Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
* Is aged 20 to 45 years, inclusive.
* Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2).
Healthy Caucasian participants:
* Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.
* Is aged 20 to 45 years, inclusive; are of Caucasian descent (born to Caucasian parents and grandparents and has lived outside original country for less than 5 years) and maintains their original diet and lifestyle.
* Weighs at least 50 kg and have a body mass index between 18.5 and 30.0 kg/m2.
Exclusion Criteria
20 Years
45 Years
MALE
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_CHAIR
Takeda
Locations
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Sumida-ku, Tokyo, Japan
Countries
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Other Identifiers
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U1111-1162-6078
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-142691
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-114/CPH-001
Identifier Type: -
Identifier Source: org_study_id
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