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Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02153099
Recruitment Status : Completed
First Posted : June 2, 2014
Results First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dose Finding Study
Interventions Drug: TAK-058 (ENV8058)
Drug: Placebo
Enrollment 48
Recruitment Details Participants took part in the study at 1 investigative site in the United States from 14 May 2014 (signing of informed consent) to 13 November 2014.
Pre-assignment Details Healthy Volunteers were enrolled in 1 of 6 Dose Cohorts: (5 mg, 15 mg, 30 mg, 45 mg, 75 mg, 150 mg TAK-058) or placebo.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Hide Arm/Group Description TAK-058 (ENV8058) 5 mg, 100 mL oral solution, once on Day 1. TAK-058 15 mg, 100 mL oral solution, once on Day 1. TAK-058 30 mg, 100 mL oral solution, once on Day 1. TAK-058 45 mg, 100 mL oral solution, once on Day 1. TAK-058 75 mg, 100 mL oral solution, once on Day 1. TAK-058 150 mg, 100 mL oral solution, once on Day 1. TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
Period Title: Overall Study
Started 6 6 6 6 6 6 12
Completed 6 6 6 6 6 6 12
Not Completed 0 0 0 0 0 0 0
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo Total
Hide Arm/Group Description TAK-058 5 mg, 100 mL oral solution, once on Day 1. TAK-058 15 mg, 100 mL oral solution, once on Day 1. TAK-058 30 mg, 100 mL oral solution, once on Day 1. TAK-058 45 mg, 100 mL oral solution, once on Day 1. TAK-058 75 mg, 100 mL oral solution, once on Day 1. TAK-058 150 mg, 100 mL oral solution, once on Day 1. TAK-058 placebo-matching, 100 mL oral solution, once on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 12 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
33.7  (11.38) 37.0  (14.01) 35.3  (10.71) 34.2  (7.78) 41.5  (10.93) 30.8  (8.54) 34.2  (9.11) 35.1  (10.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Female
1
  16.7%
1
  16.7%
2
  33.3%
2
  33.3%
1
  16.7%
0
   0.0%
2
  16.7%
9
  18.8%
Male
5
  83.3%
5
  83.3%
4
  66.7%
4
  66.7%
5
  83.3%
6
 100.0%
10
  83.3%
39
  81.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Asian 1 0 0 1 0 0 1 3
Black or African American 2 1 1 1 3 1 3 12
Native Hawaiian or other Pacific Islander 0 0 0 0 0 0 1 1
White 3 5 5 4 3 5 7 32
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Hispanic or Latino 0 3 1 3 1 2 2 12
Non-Hispanic or non-Latino 6 3 5 3 5 4 10 36
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
6 6 6 6 6 6 12 48
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
171.2  (4.40) 167.7  (6.44) 174.7  (15.20) 170.2  (10.42) 178.7  (8.78) 175.5  (8.69) 176.1  (12.91) 173.8  (10.49)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
72.73  (10.683) 70.65  (6.763) 81.72  (20.142) 79.38  (10.860) 86.17  (12.796) 80.50  (16.471) 72.77  (12.359) 77.09  (13.514)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
24.79  (3.110) 25.11  (1.674) 26.35  (3.086) 27.39  (2.440) 26.86  (1.989) 25.89  (2.728) 23.42  (2.533) 25.40  (2.770)
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Never smoked 5 5 5 6 5 5 11 42
Current smoker 0 0 0 0 0 0 0 0
Ex-smoker 1 1 1 0 1 1 1 6
Caffeine Consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Yes 3 3 4 4 4 3 6 27
No 3 3 2 2 2 3 6 21
Female Reproductive Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 48 participants
Postmenopausal 1 1 1 0 0 0 0 3
Surgically Sterile 0 0 1 2 1 0 2 6
Female of Childbearing Potential 0 0 0 0 0 0 0 0
Subject is Male 5 5 4 4 5 6 10 39
1.Primary Outcome
Title Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Hide Description Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Time Frame Baseline up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 12
Measure Type: Number
Unit of Measure: percentage of participants
16.7 0 50.0 0 16.7 0 8.3
2.Primary Outcome
Title Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
Hide Description The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
Time Frame Baseline up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 12
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 0 0 0
3.Primary Outcome
Title Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Hide Description The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.
Time Frame Baseline up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6 12
Measure Type: Number
Unit of Measure: percentage of participants
Any Vital Sign - Abnormal Low 66.7 16.7 33.3 33.3 50.0 16.7 50.0
Any Vital Sign - Abnormal High 0 16.7 0 0 0 16.7 0
Any Vital Sign - Any Abnormality 66.7 33.3 33.3 33.3 50.0 33.3 50.0
Systolic Blood Pressure <85 mmHg 16.7 0 33.3 0 0 16.7 0
Systolic Blood Pressure >180 mmHg 0 0 0 0 0 0 0
Systolic Blood Pressure - Any Abnormality 16.7 0 33.3 0 0 16.7 0
Diastolic Blood Pressure <50 mmHg 0 0 0 16.7 16.7 0 0
Diastolic Blood Pressure >110 mmHg 0 0 0 0 0 0 0
Diastolic Blood Pressure - Any Abnormality 0 0 0 16.7 16.7 0 0
Pulse <50 bpm 50.0 16.7 16.7 16.7 50.0 0 33.3
Pulse >120 bpm 0 16.7 0 0 0 16.7 0
Pulse - Any Abnormality 50.0 33.3 16.7 16.7 50.0 16.7 33.3
Temperature <35.6 degrees Celsius 16.7 0 0 0 0 0 25.0
Temperature >37.7 degrees Celsius 0 0 0 0 0 0 0
Temperature - Any Abnormality 16.7 0 0 0 0 0 25.0
4.Secondary Outcome
Title Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)
Hide Description Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population included all enrolled participants.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
142.4  (43.68) 565.0  (112.07) 824.7  (297.45) 1248.2  (254.06) 1563.3  (339.51) 2136.7  (818.04)
5.Secondary Outcome
Title AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)
Hide Description (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]).
Time Frame Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all enrolled participants.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
617.8  (334.31) 2297.8  (678.69) 3243.9  (1261.96) 5027.3  (1001.82) 6275.4  (1535.27) 9385.8  (3398.36)
6.Secondary Outcome
Title AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)
Hide Description AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time Frame Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all enrolled participants.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
620.5  (334.86) 2305.5  (678.59) 3252.1  (1264.03) 5038.9  (998.48) 6292.1  (1546.90) 9407.9  (3402.50)
7.Secondary Outcome
Title Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)
Hide Description Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all enrolled participants.
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg
Hide Arm/Group Description:
TAK-058 5 mg, 100 mL oral solution, once on Day 1.
TAK-058 15 mg, 100 mL oral solution, once on Day 1.
TAK-058 30 mg, 100 mL oral solution, once on Day 1.
TAK-058 45 mg, 100 mL oral solution, once on Day 1.
TAK-058 75 mg, 100 mL oral solution, once on Day 1.
TAK-058 150 mg, 100 mL oral solution, once on Day 1.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
2.814  (1.0871) 5.300  (2.2727) 5.925  (4.5780) 9.611  (7.3329) 10.486  (7.1865) 8.601  (7.9332)
Time Frame First dose of study drug to 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Hide Arm/Group Description TAK-058 5 mg, 100 mL oral solution, once on Day 1. TAK-058 15 mg, 100 mL oral solution, once on Day 1. TAK-058 30 mg, 100 mL oral solution, once on Day 1. TAK-058 45 mg, 100 mL oral solution, once on Day 1. TAK-058 75 mg, 100 mL oral solution, once on Day 1. TAK-058 150 mg, 100 mL oral solution, once on Day 1. TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
All-Cause Mortality
Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 4: TAK-058 5 mg Cohort 1: TAK-058 15 mg Cohort 2: TAK-058 30 mg Cohort 3: TAK-058 45 mg Cohort 5: TAK-058 75 mg Cohorts 6: TAK-058 150 mg Cohort 1-6: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/6 (0.00%)   3/6 (50.00%)   0/6 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   1/12 (8.33%) 
Gastrointestinal disorders               
Infrequent bowel movements  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Abdominal discomfort  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Constipation  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%) 
General disorders               
Asthenia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Nervous system disorders               
Dizziness postural  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%) 
Psychiatric disorders               
Euphoric mood  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02153099     History of Changes
Other Study ID Numbers: ENV8058_101
U1111-1154-9569 ( Other Identifier: World Health Organization )
First Submitted: May 29, 2014
First Posted: June 2, 2014
Results First Submitted: November 13, 2015
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015