SafetyPhase 1NCT02209506
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
A Phase 1 study testing MLN3126 in people with Safety and Tolerability, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Pharmacokinetics
- What is being tested?
- MLN3126
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 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
- Part A (Healthy non-Japanese participants):
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures, including requesting that a participant fast for any laboratory evaluations.
- Is a male or female adult, 18 to 55 years of age, inclusive, at the time of informed consent and study drug dosing.
- Is a healthy adult male or female participant as evidenced by their medical history, complete physical examination, vital signs, electrocardiogram (ECG), and safety laboratory evaluations.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30 kg/m^2 inclusive at Screening.
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- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent throughout the duration of the study to their next postconfinement menstruation. In addition, participants must be advised not to donate ova during this period.
- Part B (Healthy Japanese participants):
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures, including requesting that a participant fast for any laboratory evaluations.
- Is a male or female adult, 20 to 55 years of age, inclusive, at the time of informed consent and study drug dosing, is of Japanese descent (born to Japanese parents and grandparents and has lived outside Japan for less than 15 years), and maintains a Japanese diet and lifestyle.
- Is a healthy adult male or female participant as evidenced by their medical history, complete physical examination, vital signs, ECG, and safety laboratory evaluations.
- Weighs at least 45 kg and has a BMI between 18 and 28 kg/m^2 inclusive at Screening.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after the last dose.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent throughout the duration of the study to their next postconfinement menstruation. In addition, participants must be advised not to donate ova during this period.
Who cannot join
- Part A (Healthy non-Japanese participants) and Part B (Healthy Japanese participants):
- Has received any investigational compound within 30 days or 5 half-lives of the investigational compound, whichever is longer, prior to the first dose of study medication.
- Has received MLN3126 in a previous clinical study.
- Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (GI), or endocrine disease or allergic skin rash or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- Has a known hypersensitivity to any component of the formulation of MLN3126.
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- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 or more alcoholic beverages per day) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products section of the protocol.
- If female, the participant is pregnant or lactating or intending to become pregnant before or during the study, including the timeframe to the participant's next post-confinement menstruation after participating in this study.
- If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
- Has current or recent (within 6 months) GI disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption [eg, bariatric surgery or bowel resection], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent [more than once per week] occurrence of heartburn).
- Has Gilbert's syndrome or bilirubin level 1.2x the upper limits of normal (ULN).
- Has a history of cancer, except basal cell carcinoma, that has been in remission for at least 5 years prior to Day 1.
- Has a positive test result for hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (anti-HCV) at Screening or a known history of human immunodeficiency virus infection.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).
- Has poor peripheral venous access.
- Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis) or had a transfusion of any blood product within 45 days prior to Day 1.
- Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator.
- Has a QT interval with Fridericia correction method (QTcF) > 430 milliseconds (ms) for men or > 450 ms for women or a PR outside the range of 120 to 210 ms confirmed upon repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (Day -1).
- Has abnormal Screening or Check-in (Day -1) laboratory values that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.5 ULN.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Ascending Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Non-Japanese and Japanese Subjects
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
Read the detailed description
MLN3126 is being tested to find a safe and well-tolerated dose in healthy people and to assess how MLN3126 is processed by the body. In total, approximately 64 participants will be enrolled in the study.
This study is composed of 2 parts: Part A healthy non-Japanese participants and Part B healthy Japanese participants. Each part will consist of 4 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive MLN3126 and 2 participants will receive matched placebo within 30 minutes after the start of a standard breakfast. The starting dose will be 100 mg followed by doses of 300 mg, 800 mg, and a dose to be determined during the study. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 20 days. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.
Due to toxicology findings from a long-term animal study, Takeda made the decision to terminate this study. No clinically significant safety and/or tolerability issues have been observed or reported in participants exposed to MLN3126.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Being tested
- MLN3126, MLN3126 Matched Placebo
- Keywords
- MLN3126
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN3126Drug
MLN3126 tablets
MLN3126 Matched PlaceboDrug
MLN3126 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A: MLN3126 100 mg Non-Japanese Participants | Experimental | MLN3126 100 mg, administered orally as tablets once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. Receives: Drug: MLN3126 |
| Cohort 2A: MLN3126 300 mg Non-Japanese Participants | Experimental | MLN3126 300 mg, administered orally as tablets, orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. Receives: Drug: MLN3126 |
| Cohort 3A: MLN3126 800 mg Non-Japanese Participants | Experimental | MLN3126 800 mg, administered orally as tablets once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. Receives: Drug: MLN3126 |
| Cohort 4A: MLN3126 TBD Non-Japanese Participants | Experimental | The MLN3126 dose for this Cohort will be determined based on data collected from Cohort 3A. MLN3126, tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. Receives: Drug: MLN3126 |
| Cohorts 1A - 4A: Matched Placebo Non-Japanese Participants | Experimental | MLN3126 placebo-matching tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. Receives: Drug: MLN3126 Matched Placebo |
| Cohort 1B: MLN3126 100 mg Japanese Participants | Experimental | MLN3126 100 mg, administered orally as tablets, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 though 15) in healthy, Japanese participants. Receives: Drug: MLN3126 |
| Cohort 2B: MLN3126 300 mg Japanese Participants | Experimental | MLN3126 300 mg, administered orally as tablets, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, Japanese participants. Receives: Drug: MLN3126 |
| Cohort 3B: MLN3126 800 mg Japanese Participants | Experimental | MLN3126 800 mg, tablets, orally, once on Day 1, followed by a 7 day washout period, followed by MLN3126 800 mg, tablets, orally, once daily for 7 days (Days 9 through 15) in healthy, Japanese participants. Receives: Drug: MLN3126 |
| Cohort 4B: MLN3126 TBD Japanese Participants | Experimental | The MLN3126 dose for this Cohort will be determined based on data collected from Cohort 3B. MLN3126, tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, Japanese participants. Receives: Drug: MLN3126 |
| Cohorts 1B - 4B: Matched Placebo Japanese Participants | Experimental | MLN3126 placebo-matching tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily for 7 days (Days 9 through 15) in healthy, Japanese participants. Receives: Drug: MLN3126 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 (TEAEs)
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Baseline up to 7 days after last dose of study drug (Day 22)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose
A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.
Measured: Baseline up to 7 days after last dose of study drug (Day 22)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.
Measured: Baseline up to 7 days after last dose of study drug (Day 22)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.
Measured: Baseline up to 7 days after last dose of study drug (Day 22)
Secondary outcomes (16)
Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dose
CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)
M-I is the inactive metabolite of MLN3126.
Measured: Day 1: predose and at multiple timepoints (up to 96 hours) post-dose
Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1
M-I is the inactive metabolite of MLN3126.
Measured: Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15
M-I is the inactive metabolite of MLN3126.
Measured: Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Ae (0-4): Amount of MLN3126 and Its Metabolite Excreted in Urine From 0 to 4 Hours Post Dose
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose
Fe (0-4): Fraction of Dose of MLN3126 and Its Metabolite Excreted Unchanged in Urine From 0 to 4 Hours Post Dose
M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose
CLr: Renal Clearance of MLN3126 and Its Metabolite
CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr). M-I is the inactive metabolite of MLN3126.
Measured: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionDec 2014
Why it stopped: Long-term animal toxicology findings (see detailed description).
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 SafetyStudies 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
- 23 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
- NCT02209506
- Sponsor's protocol ID
- MLN3126_103
- Other IDs
- U1111-1156-8528
- Status last verified
- Jul 2016
- First submitted
- 4 Aug 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 Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Ascending Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Non-Japanese and Japanese Subjects
- ClinicalTrials.gov ID
- NCT02209506
- Acronym / sponsor ID
- MLN3126_103
- Conditions
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Keywords
- MLN3126
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Long-term animal toxicology findings (see detailed description).
- Enrolment
- 23 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Aug 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 single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
Detailed description
MLN3126 is being tested to find a safe and well-tolerated dose in healthy people and to assess how MLN3126 is processed by the body. In total, approximately 64 participants will be enrolled in the study.
This study is composed of 2 parts: Part A healthy non-Japanese participants and Part B healthy Japanese participants. Each part will consist of 4 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive MLN3126 and 2 participants will receive matched placebo within 30 minutes after the start of a standard breakfast. The starting dose will be 100 mg followed by doses of 300 mg, 800 mg, and a dose to be determined during the study. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 20 days. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.
Due to toxicology findings from a long-term animal study, Takeda made the decision to terminate this study. No clinically significant safety and/or tolerability issues have been observed or reported in participants exposed to MLN3126.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A: MLN3126 100 mg Non-Japanese Participants | Experimental | Drug: MLN3126MLN3126 100 mg, administered orally as tablets once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. |
| Cohort 2A: MLN3126 300 mg Non-Japanese Participants | Experimental | Drug: MLN3126MLN3126 300 mg, administered orally as tablets, orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. |
| Cohort 3A: MLN3126 800 mg Non-Japanese Participants | Experimental | Drug: MLN3126MLN3126 800 mg, administered orally as tablets once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. |
| Cohort 4A: MLN3126 TBD Non-Japanese Participants | Experimental | Drug: MLN3126The MLN3126 dose for this Cohort will be determined based on data collected from Cohort 3A. MLN3126, tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. |
| Cohorts 1A - 4A: Matched Placebo Non-Japanese Participants | Experimental | Drug: MLN3126 Matched PlaceboMLN3126 placebo-matching tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, non-Japanese participants. |
| Cohort 1B: MLN3126 100 mg Japanese Participants | Experimental | Drug: MLN3126MLN3126 100 mg, administered orally as tablets, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 though 15) in healthy, Japanese participants. |
| Cohort 2B: MLN3126 300 mg Japanese Participants | Experimental | Drug: MLN3126MLN3126 300 mg, administered orally as tablets, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, Japanese participants. |
| Cohort 3B: MLN3126 800 mg Japanese Participants | Experimental | Drug: MLN3126MLN3126 800 mg, tablets, orally, once on Day 1, followed by a 7 day washout period, followed by MLN3126 800 mg, tablets, orally, once daily for 7 days (Days 9 through 15) in healthy, Japanese participants. |
| Cohort 4B: MLN3126 TBD Japanese Participants | Experimental | Drug: MLN3126The MLN3126 dose for this Cohort will be determined based on data collected from Cohort 3B. MLN3126, tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily administration for 7 days (Days 9 through 15) in healthy, Japanese participants. |
| Cohorts 1B - 4B: Matched Placebo Japanese Participants | Experimental | Drug: MLN3126 Matched PlaceboMLN3126 placebo-matching tablets, administered orally, once on Day 1, followed by a 7 day washout period, followed by once daily for 7 days (Days 9 through 15) in healthy, Japanese participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures, including requesting that a participant fast for any laboratory evaluations.
- Is a male or female adult, 18 to 55 years of age, inclusive, at the time of informed consent and study drug dosing.
- Is a healthy adult male or female participant as evidenced by their medical history, complete physical examination, vital signs, electrocardiogram (ECG), and safety laboratory evaluations.
- Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30 kg/m^2 inclusive at Screening.
Key exclusion criteria (21 listed)
- Has received any investigational compound within 30 days or 5 half-lives of the investigational compound, whichever is longer, prior to the first dose of study medication.
- Has received MLN3126 in a previous clinical study.
- Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (GI), or endocrine disease or allergic skin rash or other abnormality which may impact the ability of the participant to participate or potentially confound the study results.
- Has a known hypersensitivity to any component of the formulation of MLN3126.
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 |
|---|---|---|
| MLN3126MLN3126 tablets | Drug | Cohort 1A: MLN3126 100 mg Non-Japanese Participants, Cohort 1B: MLN3126 100 mg Japanese Participants, Cohort 2A: MLN3126 300 mg Non-Japanese Participants, Cohort 2B: MLN3126 300 mg Japanese Participants, Cohort 3A: MLN3126 800 mg Non-Japanese Participants, Cohort 3B: MLN3126 800 mg Japanese Participants, Cohort 4A: MLN3126 TBD Non-Japanese Participants, Cohort 4B: MLN3126 TBD Japanese Participants |
| MLN3126 Matched PlaceboMLN3126 placebo-matching tablets | Drug | Cohorts 1A - 4A: Matched Placebo Non-Japanese Participants, Cohorts 1B - 4B: Matched Placebo Japanese Participants |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 7 days after last dose of study drug (Day 22)
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose
Time frame: Baseline up to 7 days after last dose of study drug (Day 22)
A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to 7 days after last dose of study drug (Day 22)
The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to 7 days after last dose of study drug (Day 22)
The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.
16 secondary outcomes
Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dose
CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)
Time frame: Day 1: predose and at multiple timepoints (up to 96 hours) post-dose
Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1
Time frame: Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15
Time frame: Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
Ae (0-4): Amount of MLN3126 and Its Metabolite Excreted in Urine From 0 to 4 Hours Post Dose
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose
Fe (0-4): Fraction of Dose of MLN3126 and Its Metabolite Excreted Unchanged in Urine From 0 to 4 Hours Post Dose
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose
CLr: Renal Clearance of MLN3126 and Its Metabolite
Time frame: Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose
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.
Medical Director Clinical Science study director
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 MLN3126 in people with Safety and Tolerability, run by Takeda at 1 site in United States.
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 16 inclusion and 21 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: stopped early, 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 United States. 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. 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 (TEAEs) (time frame: Baseline up to 7 days after last dose of study drug (Day 22)). The study lists 4 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.