Clinical PharmacologyPhase 1NCT02286518
TAK-114 Single- and Multiple-Dose Phase 1 Study
A Phase 1 study testing TAK-114 10 mg capsule in people with Clinical Pharmacology, run by Takeda at 1 site in Japan.
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 male participants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- TAK-114 10 mg capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2014to Apr 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese 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.
- 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.
Who cannot join
- Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
Trial locations and contacts
1 site in 1 country.
About this study
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
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 male participants.
Read the detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.
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
- Clinical Pharmacology
- Being tested
- TAK-114 10 mg capsule, TAK-114 matched placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-114 10 mg capsuleDrug
TAK-114 matched placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A: TAK-114 10 mg | Experimental | Orally, once only. Receives: Drug: TAK-114 10 mg capsule |
| Cohort 1B: TAK-114 10 mg | Experimental | Orally, once Receives: Drug: TAK-114 10 mg capsule |
| Cohort 2A: TAK-114 20 mg | Experimental | Orally, once Receives: Drug: TAK-114 10 mg capsule |
| Cohort 2B: TAK-114 20 mg | Experimental | Orally, once Receives: Drug: TAK-114 10 mg capsule |
| Cohort 3A: TAK-114 50 mg | Experimental | Orally, once Receives: Drug: TAK-114 10 mg capsule |
| Cohort 3B: TAK-114 50 mg | Experimental | Orally, once Receives: Drug: TAK-114 10 mg capsule |
| Cohort 4a: TAK-114 20 mg | Experimental | Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast Receives: Drug: TAK-114 10 mg capsule |
| Cohort 4b: TAK-114 20 mg | Experimental | Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state Receives: Drug: TAK-114 10 mg capsule |
| Cohort 5A: TAK-114 20 mg | Experimental | Orally, Twice daily, 10 days Receives: Drug: TAK-114 10 mg capsule |
| Cohort 5B: TAK-114 20 mg | Experimental | Orally, Twice daily, 10 days Receives: Drug: TAK-114 10 mg capsule |
| Cohort 6A: TAK-114 50 mg | Experimental | Orally, Twice daily, 10 days Receives: Drug: TAK-114 10 mg capsule |
| Cohort 6B: TAK-114 50 mg | Experimental | Orally, Twice daily, 10 days Receives: Drug: TAK-114 10 mg capsule |
| Cohort 1A, 2A, 3A: TAK-114 placebo | Placebo comparator | Cohort 1A, 2A, 3A: Orally, once Receives: Drug: TAK-114 matched placebo |
| Cohort 5A: TAK-114 placebo | Placebo comparator | Cohort 5A: Orally, Twice daily, 10 days Receives: Drug: TAK-114 matched placebo |
| Cohort 6A: TAK-114 placebo | Placebo comparator | Cohort 6A: Orally, Twice daily, 10 days Receives: Drug: TAK-114 matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Measured: Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)
Number of Participants With TEAEs Related to Vital Signs
Measured: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With TEAEs Related to Body Weight
Measured: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported.
Measured: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Measured: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Measured: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Secondary outcomes (7)
Cmax - Maximum Observed Plasma Concentration for TAK-114
Measured: Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3
AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2
Measured: Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2
AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3
Measured: Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114
Measured: Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3
Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.
Measured: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3
Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.
Measured: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1
Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.
Measured: Day 1: 0 to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286518
- Sponsor's protocol ID
- TAK-114/CPH-001
- Other IDs
- U1111-1162-6078, JapicCTI-142691
- Status last verified
- Jun 2016
- First submitted
- 5 Nov 2014
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02286518
- Acronym / sponsor ID
- TAK-114/CPH-001
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Posted 25 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 male participants.
Detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple oral dose study in healthy Caucasian and Japanese male participants.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A: TAK-114 10 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, once only. |
| Cohort 1B: TAK-114 10 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, once |
| Cohort 2A: TAK-114 20 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, once |
| Cohort 2B: TAK-114 20 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, once |
| Cohort 3A: TAK-114 50 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, once |
| Cohort 3B: TAK-114 50 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, once |
| Cohort 4a: TAK-114 20 mg | Experimental | Drug: TAK-114 10 mg capsulePeriod 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast |
| Cohort 4b: TAK-114 20 mg | Experimental | Drug: TAK-114 10 mg capsulePeriod 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state |
| Cohort 5A: TAK-114 20 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, Twice daily, 10 days |
| Cohort 5B: TAK-114 20 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, Twice daily, 10 days |
| Cohort 6A: TAK-114 50 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, Twice daily, 10 days |
| Cohort 6B: TAK-114 50 mg | Experimental | Drug: TAK-114 10 mg capsuleOrally, Twice daily, 10 days |
| Cohort 1A, 2A, 3A: TAK-114 placebo | Placebo comparator | Drug: TAK-114 matched placeboCohort 1A, 2A, 3A: Orally, once |
| Cohort 5A: TAK-114 placebo | Placebo comparator | Drug: TAK-114 matched placeboCohort 5A: Orally, Twice daily, 10 days |
| Cohort 6A: TAK-114 placebo | Placebo comparator | Drug: TAK-114 matched placeboCohort 6A: Orally, Twice daily, 10 days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
- 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.
Key exclusion criteria (1 listed)
- Participants have a known hypersensitivity to any component of the formulation of TAK-114 or any herb medicine or supplement related to Indigo naturalis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-114 10 mg capsule | Drug | Cohort 1A: TAK-114 10 mg, Cohort 1B: TAK-114 10 mg, Cohort 2A: TAK-114 20 mg, Cohort 2B: TAK-114 20 mg, Cohort 3A: TAK-114 50 mg, Cohort 3B: TAK-114 50 mg, Cohort 4a: TAK-114 20 mg, Cohort 4b: TAK-114 20 mg, Cohort 5A: TAK-114 20 mg, Cohort 5B: TAK-114 20 mg, Cohort 6A: TAK-114 50 mg, Cohort 6B: TAK-114 50 mg |
| TAK-114 matched placebo | Drug | Cohort 1A, 2A, 3A: TAK-114 placebo, Cohort 5A: TAK-114 placebo, Cohort 6A: TAK-114 placebo |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time frame: Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported.
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Time frame: Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
7 secondary outcomes
Cmax - Maximum Observed Plasma Concentration for TAK-114
Time frame: Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3
AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2
Time frame: Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2
AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3
Time frame: Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114
Time frame: Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3
Time frame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3
Time frame: Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3
Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1
Time frame: Day 1: 0 to 48 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study chair
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-114 10 mg capsule in people with Clinical Pharmacology, run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) (time frame: Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.