Healthy VolunteersPhase 1NCT02447458

MLN3126 Single Rising Dose Study

A Phase 1 study testing MLN3126 in people with Healthy Volunteers, run by Takeda at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of MLN3126 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: Healthy Volunteers
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: 39 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Feb 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

In the opinion of the investigator, the participant was capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signed and dated a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Is a male or female adult, aged 18 to 55 years, inclusive, at the time of informed consent and study drug dosing.
Is a healthy adult male or female subject as evidenced by their medical history, complete physical examination, vital signs, ECG, and safety laboratory evaluations.
Weighed at least 45 kg (99 lbs) and had a body mass index (BMI) between 18 and 30.0 kg/m2 inclusive at Screening.
A male participant who was nonsterilized and sexually active with a female partner of childbearing potential agreed to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. In addition, participants were advised not to donate sperm during this period.
A female participant of childbearing potential who was sexually active with a nonsterilized male partner agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study to their next postconfinement menstruation. In addition participants were advised not to donate ova during this period.

Who cannot join

Any participant who meets any of the following criteria will not qualify for entry into the study:
Has received any investigational compound within 30 days prior to the first dose of study medication.
Is an immediate family member, study site employee, or in a dependent 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, GI, or endocrine disease 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.
Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).

Show all 20Show fewer

Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as 4 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, or intending to donate ova, before or during, the study; including the timeframe to participant's next postconfinement 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 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 giving reasonable suspicion of a disease that would contra indicate taking MLN3126 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 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 a history of cancer or other malignancy, 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, antibody to hepatitis C virus, at Screening or a known history of human immunodeficiency virus infection.
Has used nicotine-containing products (this includes, but is 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) ECG. Entry of any subject with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or medically qualified subinvestigator.
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.
Has QT interval with Fridericia correction method (QTcF) >430 ms for men and >450 ms for women or PR outside the range of 120 to 220 ms confirmed upon repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1).

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Eatontown, New Jersey

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetics Study of Escalating Single Doses of MLN3126 in Healthy Subjects

The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy participants.

Read the detailed description

The drug tested in this study is called MLN3126. The study evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and the potential effect of food on the PK of MLN3126 and its M-I metabolite following single oral dose administrations.

This study planned to enroll approximately 48 healthy participants, who were to be enrolled in 1 of the 6 dose cohorts or matching placebo in an ascending fashion. Participants were randomly assigned to MLN3126 or placebo within each cohort- which remained undisclosed to the participant and study doctor during the study (unless there was an urgent medical need):

Cohort 1 - MLN3126 300 mg or matching placebo
Cohort 2 - MLN3126 600 mg or matching placebo
Cohort 3 - MLN3126 1000 mg or matching placebo
Cohort 3 - MLN3126 1000 mg or matching placebo (fed regimen)
Cohort 4 - MLN3126 1500 mg or matching placebo
Cohort 5 - MLN3126 2000 mg or matching placebo
Cohort 6 - Did not taken place due to termination of the study

All participants were asked to take the required tablets at the same time throughout the study.

This single-centre trial was conducted in The United States. Participants were confined to the clinic for 5 days, and were contacted by telephone on day 14 (±2days) for a follow-up assessment.

This study was terminated after completion of Cohort 5 due to findings of study site non-compliance to Good Clinical Practice (GCP) regarding study documentation. There were no safety concerns.

Conditions: Healthy Volunteers
Being tested: MLN3126, MLN3126 Placebo
Keywords: Drug therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MLN3126Drug
MLN3126 tablets
MLN3126 PlaceboDrug
MLN3126 placebo-matching tablets

Study groups in NCT02447458
Study group	Role	What they receive
Cohort 1: MLN3126 300 mg	Experimental	MLN3126 300 mg tablets, orally, fasting, once on Day 1. Receives: Drug: MLN3126
Cohort 2: MLN3126 600 mg	Experimental	MLN3126 600 mg tablets, orally, fasting, once on Day 1. Receives: Drug: MLN3126
Cohort 3: MLN3126 1000 mg	Experimental	MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1. Receives: Drug: MLN3126
Cohort 4: MLN3126 1500 mg	Experimental	MLN3126 1500 mg administered orally as tablets, once on Day 1. Receives: Drug: MLN3126
Cohort 5: MLN3126 2000 mg	Experimental	MLN3126 2000 mg tablets, orally, fasting, once on Day 1. Receives: Drug: MLN3126
Cohort 6	Experimental	Did not take place due to termination of the study. Receives: Drug: MLN3126
Placebo: Cohort 1-6	Placebo comparator	Placebo-matching MLN3126 tablets, orally, once on Day 1. Receives: Drug: MLN3126 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose
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 (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Up to Day 22
Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose
Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.
Measured: Up to Day 16
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate [beats per minute (bpm) or heart rate]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.
Measured: Up to Day 16
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.
Measured: Up to Day 16

Secondary outcomes (9)

Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I
Tmax is the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration
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: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity
AUC(0-inf) is measure of area under the curve from time 0 to infinity.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
CL/F: Oral Clearance of MLN3126
CL/F is apparent clearance of the drug from the plasma, after extravascular administration.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
T ½: Half-life of MLN3126 and Metabolite M-I
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine
Ae (0-96) is the total amount of drug excreted in urine from time 0 to time 96 hours.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Fe: Fraction of MLN3126 Excreted in the Urine
Fe is the Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Renal Clearance (CLr) of MLN3126 and Metabolite M-I
Renal clearance was calculated as CLr=Ae(0-96)/AUC (0-96).
Measured: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Feb 2014

First posted18 May 2015 (estimated)
Study startSep 2013
Primary completionJan 2014
Study completionFeb 2014

Why it stopped: Site non-compliance to GCP (No safety concerns. 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 Healthy VolunteersStudies 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: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02447458
Sponsor's protocol ID: MLN3126_102
Other IDs: U1111-1163-1717
Status last verified: Jul 2015
First submitted: 14 May 2015
Last updated: 5 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 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 Pharmacokinetics Study of Escalating Single Doses of MLN3126 in Healthy Subjects
ClinicalTrials.gov ID: NCT02447458
Acronym / sponsor ID: MLN3126_102
Conditions: Healthy Volunteers
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Site non-compliance to GCP (No safety concerns. See detailed description)
Enrolment: 39 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Jan 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 5 Aug 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 was to evaluate the safety, tolerability, and pharmacokinetics of MLN3126 when administered as a single dose of tablets at escalating dose levels in healthy participants.

Detailed description

Cohort 1 - MLN3126 300 mg or matching placebo
Cohort 2 - MLN3126 600 mg or matching placebo
Cohort 3 - MLN3126 1000 mg or matching placebo
Cohort 3 - MLN3126 1000 mg or matching placebo (fed regimen)
Cohort 4 - MLN3126 1500 mg or matching placebo
Cohort 5 - MLN3126 2000 mg or matching placebo
Cohort 6 - Did not taken place due to termination of the study

All participants were asked to take the required tablets at the same time throughout the study.

This single-centre trial was conducted in The United States. Participants were confined to the clinic for 5 days, and were contacted by telephone on day 14 (±2days) for a follow-up assessment.

This study was terminated after completion of Cohort 5 due to findings of study site non-compliance to Good Clinical Practice (GCP) regarding study documentation. There were no safety concerns.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Cohort 1: MLN3126 300 mg	Experimental	Drug: MLN3126MLN3126 300 mg tablets, orally, fasting, once on Day 1.
Cohort 2: MLN3126 600 mg	Experimental	Drug: MLN3126MLN3126 600 mg tablets, orally, fasting, once on Day 1.
Cohort 3: MLN3126 1000 mg	Experimental	Drug: MLN3126MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
Cohort 4: MLN3126 1500 mg	Experimental	Drug: MLN3126MLN3126 1500 mg administered orally as tablets, once on Day 1.
Cohort 5: MLN3126 2000 mg	Experimental	Drug: MLN3126MLN3126 2000 mg tablets, orally, fasting, once on Day 1.
Cohort 6	Experimental	Drug: MLN3126Did not take place due to termination of the study.
Placebo: Cohort 1-6	Placebo comparator	Drug: MLN3126 PlaceboPlacebo-matching MLN3126 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 (7 listed)

In the opinion of the investigator, the participant was capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signed and dated a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Is a male or female adult, aged 18 to 55 years, inclusive, at the time of informed consent and study drug dosing.
Is a healthy adult male or female subject as evidenced by their medical history, complete physical examination, vital signs, ECG, and safety laboratory evaluations.
Weighed at least 45 kg (99 lbs) and had a body mass index (BMI) between 18 and 30.0 kg/m2 inclusive at Screening.

Key exclusion criteria (20 listed)

Any participant who meets any of the following criteria will not qualify for entry into the study:
Has received any investigational compound within 30 days prior to the first dose of study medication.
Is an immediate family member, study site employee, or in a dependent 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, GI, or endocrine disease 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 1: MLN3126 300 mg, Cohort 2: MLN3126 600 mg, Cohort 3: MLN3126 1000 mg, Cohort 4: MLN3126 1500 mg, Cohort 5: MLN3126 2000 mg, Cohort 6
MLN3126 PlaceboMLN3126 placebo-matching tablets	Drug	Placebo: Cohort 1-6

Primary outcome

Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose
Time frame: Up to Day 22
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 (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose
Time frame: Up to Day 16
Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.
Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose
Time frame: Up to Day 16
Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate [beats per minute (bpm) or heart rate]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.
Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose
Time frame: Up to Day 16
A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.

9 secondary outcomes

Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
CL/F: Oral Clearance of MLN3126
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
T ½: Half-life of MLN3126 and Metabolite M-I
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Fe: Fraction of MLN3126 Excreted in the Urine
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)
Renal Clearance (CLr) of MLN3126 and Metabolite M-I
Time frame: Pre-dose and multiple timepoints post-dose (Up to 96 Hours)

Results and safety

Results posted to the registry on 5 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MLN3126 300 mg	5	5
MLN3126 600 mg	6	6
MLN3126 1000 mg	6	5
MLN3126 1500 mg	6	6
MLN3126 2000 mg	6	6
Placebo	10	10

Primary outcome: Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose

Time frame: Up to Day 22. Number. Unit: Participants

Measure	MLN3126 300 mg n = 5	MLN3126 600 mg n = 6	MLN3126 1000 mg n = 6	MLN3126 1500 mg n = 6	MLN3126 2000 mg n = 6	Placebo n = 10	MLN3126 1000 mg (Fed) n = 5	Placebo (Fed) n = 2
Value	1	0	1	0	1	1	1	0

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose

Time frame: Up to Day 16. Number. Unit: Percentage of Participants

Measure	MLN3126 300 mg n = 5	MLN3126 600 mg n = 6	MLN3126 1000 mg n = 6	MLN3126 1500 mg n = 6	MLN3126 2000 mg n = 6	Placebo n = 10	MLN3126 1000 mg (Fed) n = 5	Placebo (Fed) n = 2
Value	0	0	0	0	0	0	0	0

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose

Time frame: Up to Day 16. Number. Unit: Percentage of Participants

Measure	MLN3126 300 mg n = 5	MLN3126 600 mg n = 6	MLN3126 1000 mg n = 6	MLN3126 1500 mg n = 6	MLN3126 2000 mg n = 6	Placebo n = 10	MLN3126 1000 mg (Fed) n = 5	Placebo (Fed) n = 2
Pulse - supine	0	33.3	33.3	16.7	33.3	40.0	0	0
Pulse - standing 1 minute	40.0	50.0	0	16.7	16.7	20.0	40.0	0
Pulse - standing 3 minutes	20.0	50.0	0	16.7	0	10.0	40.0	0
Systolic Blood pressure (BP) - supine	20.0	0	0	0	0	0	0	0
Systolic Blood pressure - standing 1 minute	0	0	0	0	0	0	20.0	0
Systolic Blood pressure - standing 3 minutes	0	0	16.7	16.7	0	0	20.0	0
Diastolic blood pressure - supine	40.0	33.3	0	16.7	16.7	20.0	20.0	50.0
Diastolic blood pressure - standing 1 minute	20.0	33.3	33.3	0	16.7	30.0	40.0	50.0

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose

Time frame: Up to Day 16. Number. Unit: Percentage of Participants

Measure	MLN3126 600 mg n = 6	MLN3126 1000 mg n = 6	MLN3126 1500 mg n = 6	MLN3126 2000 mg n = 6	Placebo n = 10	MLN3126 1000 mg (Fed) n = 5
Heart Rate	16.7	0	16.7	33.3	20.0	0
PR Interval	16.7	33.3	0	33.3	10.0	40.0
QRS Interval	0	0	0	0	10.0	0
QTc - Fredericia's	0	0	0	0	0	0
QTc Interval	0	0	0	0	0	0

Population analysed: Safety population included all enrolled participants who received at least 1 dose of study drug.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study drug to 30 days post last dose (Up to Day 31). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MLN3126 300 mg	0 of 5 (0%)	1 of 5 (20%)	Not reported
MLN3126 600 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
MLN3126 1000 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MLN3126 1500 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
MLN3126 2000 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Placebo	0 of 10 (0%)	1 of 10 (10%)	Not reported
MLN3126 1000 mg (Fed)	0 of 5 (0%)	1 of 5 (20%)	Not reported
Placebo (Fed)	0 of 2 (0%)	0 of 2 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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.

The record lists no contact. Use the official record to reach the sponsor.

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 Healthy Volunteers, 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 7 inclusion and 20 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 5 Aug 2015. 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. 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 5 Aug 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?

Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose (time frame: Up to 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?

On the ClinicalTrials.gov record for NCT02447458.

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 5 Aug 2015.