Dose Finding StudyPhase 1NCT02334982
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
A Phase 1 study testing TAK-137 in people with Dose Finding Study, run by Takeda.
Trial summary
The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dose Finding Study
- What is being tested?
- TAK-137
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of age inclusive at the time of informed consent and first study medication dose.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
- Is able to comply with the protocol and is willing to sign the informed consent prior to undergoing any study-related procedures.
Who cannot join
- Has a known hypersensitivity to any component of the formulation of TAK-137.
- Has a medical condition such as mental retardation that can cause cognitive impairment.
- Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [C-SSRS] or has made a suicide attempt in the previous 6 months).
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
- There is any finding in the participant's medical history, physical examination, or safety laboratory tests (including safety electroencephalogram [EEG]) giving reasonable suspicion of a disease that would contraindicate taking TAK-137, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
- Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-137 in Healthy Subjects
The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.
Read the detailed description
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose. This study looked at safety (lab results and side effects) and pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) in people who took TAK-137. This study was designed as a single ascending 6 Cohort dose study with planned doses of 2, 5, 15, 50, and 100 mg and Cohort 6 dose to be determined if the maximum tolerated dose (MTD) was not reached. Anticipated enrollment was 48.
This study enrolled 47 participants and consisted of 6 Cohorts. Participants in Cohorts 1, 2, 3, 5 and 6 were randomized to receive a single dose of TAK-137 or placebo after a 10-hour fast. Participants in Cohort 4 were randomized to receive a single dose of TAK-137 or placebo under fasted conditions, followed by a single dose of TAK-137 or placebo under fed conditions 14 days later. Participants in cohort 4 will receive the same dose in both fasted and fed conditions. The starting dose was 2 mg followed by administrations of 5, 10, 0.5 and 20 mg.
This single-center trial was conducted in the United States. For Cohorts 1, 2, 3, 5, and 6 the overall time to participate in this study was up to 42 days. Participants made 4 visits to the clinic including one 5-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
For Cohort 4 the overall time to participate in this study was up to 56 days. Participants made 7 visits to the clinic including two 5-day periods of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
- Conditions
- Dose Finding Study
- Being tested
- TAK-137, Placebo
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-137Drug
TAK-137 tablets
PlaceboDrug
TAK-137 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TAK-137 2 mg | Experimental | TAK-137 2 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-137 |
| Cohort 2: TAK-137 5 mg | Experimental | TAK-137 5 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-137 |
| Cohort 3: TAK-137 10 mg | Experimental | TAK-137 10 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-137 |
| Cohort 4: TAK-137 5 mg Food Effect | Experimental | TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2. Receives: Drug: TAK-137 |
| Cohort 5: TAK-137 0.5 mg | Experimental | TAK-137 0.5 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-137 |
| Cohort 6: TAK-137 20 mg | Experimental | TAK-137 20 mg, tablets, orally, once on Day 1. Receives: Drug: TAK-137 |
| Cohorts 1-6: Placebo | Placebo comparator | TAK-137 placebo-matching tablets, orally, once on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
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 is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Day 1 to 14 days after the last dose of study medication(Up to 30 days)
Percentage of Participants With Abnormal Safety Laboratory Findings
The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.
Measured: Day 1 to 14 days after the last dose of study medication (Up to 30 Days)
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
Measured: Day 1 to 14 days after the last dose of study medication
Secondary outcomes (10)
Cmax: Maximum Observed Plasma Concentration for TAK-137
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: Day 1
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 1
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Measured: Day 1
Terminal Elimination Half-life (T1/2) for TAK-137_101
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day 1
Apparent Clearance (CL/F) for TAK-137_101
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-inf), expressed in liters per hour (L/hr).
Measured: Day 1
Apparent Volume of Distribution (Vz/F) for TAK-137_101
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.
Measured: Day 1
Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])
Total amount of drug excreted in urine from time 0 to time t, calculated as Sum (Cu*Vu), where Cu is the concentration of drug excreted in urine and Vu is the volume of urine excreted.
Measured: Day 1
Fraction of TAK-137 Excreted in Urine (Fe)
Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.
Measured: Day 1
Renal Clearance (CLr) for TAK-137
CLr is a measure of apparent clearance of the drug from the urine, calculated as CLr=Ae(0-t)/AUC(0-96).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
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 Dose Finding StudyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334982
- Sponsor's protocol ID
- TAK-137_101
- Other IDs
- U1111-1164-7376
- Status last verified
- Jan 2015
- First submitted
- 6 Jan 2015
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Doses of TAK-137 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02334982
- Acronym / sponsor ID
- TAK-137_101
- Conditions
- Dose Finding Study
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Posted 10 Feb 2015
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 characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.
Detailed description
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose. This study looked at safety (lab results and side effects) and pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) in people who took TAK-137. This study was designed as a single ascending 6 Cohort dose study with planned doses of 2, 5, 15, 50, and 100 mg and Cohort 6 dose to be determined if the maximum tolerated dose (MTD) was not reached. Anticipated enrollment was 48.
This study enrolled 47 participants and consisted of 6 Cohorts. Participants in Cohorts 1, 2, 3, 5 and 6 were randomized to receive a single dose of TAK-137 or placebo after a 10-hour fast. Participants in Cohort 4 were randomized to receive a single dose of TAK-137 or placebo under fasted conditions, followed by a single dose of TAK-137 or placebo under fed conditions 14 days later. Participants in cohort 4 will receive the same dose in both fasted and fed conditions. The starting dose was 2 mg followed by administrations of 5, 10, 0.5 and 20 mg.
This single-center trial was conducted in the United States. For Cohorts 1, 2, 3, 5, and 6 the overall time to participate in this study was up to 42 days. Participants made 4 visits to the clinic including one 5-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
For Cohort 4 the overall time to participate in this study was up to 56 days. Participants made 7 visits to the clinic including two 5-day periods of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TAK-137 2 mg | Experimental | Drug: TAK-137TAK-137 2 mg, tablets, orally, once on Day 1. |
| Cohort 2: TAK-137 5 mg | Experimental | Drug: TAK-137TAK-137 5 mg, tablets, orally, once on Day 1. |
| Cohort 3: TAK-137 10 mg | Experimental | Drug: TAK-137TAK-137 10 mg, tablets, orally, once on Day 1. |
| Cohort 4: TAK-137 5 mg Food Effect | Experimental | Drug: TAK-137TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2. |
| Cohort 5: TAK-137 0.5 mg | Experimental | Drug: TAK-137TAK-137 0.5 mg, tablets, orally, once on Day 1. |
| Cohort 6: TAK-137 20 mg | Experimental | Drug: TAK-137TAK-137 20 mg, tablets, orally, once on Day 1. |
| Cohorts 1-6: Placebo | Placebo comparator | Drug: PlaceboTAK-137 placebo-matching tablets, orally, once on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of age inclusive at the time of informed consent and first study medication dose.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.
- Is able to comply with the protocol and is willing to sign the informed consent prior to undergoing any study-related procedures.
Key exclusion criteria (6 listed)
- Has a known hypersensitivity to any component of the formulation of TAK-137.
- Has a medical condition such as mental retardation that can cause cognitive impairment.
- Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale [C-SSRS] or has made a suicide attempt in the previous 6 months).
- Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash.
- There is any finding in the participant's medical history, physical examination, or safety laboratory tests (including safety electroencephalogram [EEG]) giving reasonable suspicion of a disease that would contraindicate taking TAK-137, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
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-137TAK-137 tablets | Drug | Cohort 1: TAK-137 2 mg, Cohort 2: TAK-137 5 mg, Cohort 3: TAK-137 10 mg, Cohort 4: TAK-137 5 mg Food Effect, Cohort 5: TAK-137 0.5 mg, Cohort 6: TAK-137 20 mg |
| PlaceboTAK-137 placebo-matching tablets | Drug | Cohorts 1-6: Placebo |
Primary outcome
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
Time frame: Day 1 to 14 days after the last dose of study medication(Up to 30 days)
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 is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants With Abnormal Safety Laboratory Findings
Time frame: Day 1 to 14 days after the last dose of study medication (Up to 30 Days)
The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Time frame: Day 1 to 14 days after the last dose of study medication
The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.
10 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for TAK-137
Time frame: Day 1
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137
Time frame: Day 1
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137
Time frame: Day 1
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137
Time frame: Day 1
Terminal Elimination Half-life (T1/2) for TAK-137_101
Time frame: Day 1
Apparent Clearance (CL/F) for TAK-137_101
Time frame: Day 1
Apparent Volume of Distribution (Vz/F) for TAK-137_101
Time frame: Day 1
Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])
Time frame: Day 1
Fraction of TAK-137 Excreted in Urine (Fe)
Time frame: Day 1
Renal Clearance (CLr) for TAK-137
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- 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.
Medical Director Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-137 in people with Dose Finding Study, run by Takeda.
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 3 inclusion and 6 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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 10 Feb 2015). 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?
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (time frame: Day 1 to 14 days after the last dose of study medication(Up to 30 days)). The study lists 3 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 10 Feb 2015.