TAK-114 Single- and Multiple-Dose Phase 1 Study

Clinical Pharmacology Clinical Trial

Official title:

A Single-center, Single- and Multiple-Dose Phase 1 Study to Evaluate the Safety and Pharmacokinetics of TAK-114 in Healthy Adult Japanese and Caucasian Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286518
• Other study ID #: TAK-114/CPH-001
• Secondary ID: U1111-1162-6078J
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2014
• Last updated: September 16, 2015
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese subjects

Description:

This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese Subjects:

• All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.

• Male subjects aged 20 to 45 years, inclusive.

• All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 25.0 kg/m2.

Healthy Caucasian Subjects:

• All subjects must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol.

• Male subjects 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.

• All subjects should weigh at least 45 kg (99 lb) and have a body mass index between 18.5 and 30.0 kg/m2.

Exclusion Criteria:

• Subjects have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Pharmacology

Intervention

Drug:
• TAK-114 10 mg capsule

• TAK-114 matched placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of treatment emergent adverse events (TEAEs) in Single-dose Ascending Part	The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-114. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-114. TEAEs are defined as events occurring after the start of administration of an investigational product or events that occur due to the worsening of the present illness.	For 3 days during the treatment period	Yes
Primary	Frequency of treatment emergent adverse events (TEAEs) in Multiple-dose Ascending Part	The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-114. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-114. TEAEs are defined as events occurring after the start of administration of an investigational product or events that occur due to the worsening of the present illness.	For 12 days during the treatment period and 5 days during the follow-up period	Yes
Secondary	Plasma concentrations of unchanged TAK-114 in Single-dose Ascending Part	Single-dose Ascending Part and Food Effect Part: The pharmacokinetic parameters will be estimated from a model-independent analysis of the time course of changes in plasma concentration of TAK-114 until 48 hours after the administration of a single-dose.	For 3 days during the treatment period	No
Secondary	Plasma concentrations of unchanged TAK-114 in Food Effect Part	Single-dose Ascending Part and Food Effect Part: The pharmacokinetic parameters will be estimated from a model-independent analysis of the time course of changes in plasma concentration of TAK-114 until 48 hours after the administration of a single-dose.	For 3 days during the treatment period (excluding a the 14-day washout interval between the two periods)	No
Secondary	Plasma concentrations of unchanged TAK-114 in Multiple-dose Ascending Part	Multiple-dose Ascending Part For the start day (Day 1) and end day (Day 10) of multiple-dose administration, the pharmacokinetic parameters of TAK-114 will be estimated from a model-independent analysis of the time course of changes in plasma concentration of TAK-114 during the specified period of each day - i.e., the time course on Day 1 is for the period from prior to the first dose until 12 hours after the first dose, and the time course on Day 10 is for the period from prior to the last dose (216 hours after the first dose) until 48 hours after the last dose (264 hours after the first dose).	For 12 days during the treatment period and 5 days during the follow-up period	No
Secondary	Urinary excretion of unchanged TAK-114 (only for Cohorts 1A to 3A and Cohorts 1B to 3B)	For individual subjects, the cumulative urinary excretion rate (% of dose amount [equivalent to unchanged TAK-114]) until the end of the urine-collection period will be determined from the urinary concentration of TAK-114 and urine output during each urine-collection period.	Single-dose Ascending Part: For 3 days during the treatment period	No