Safety and Efficacy Study of EGT0001442 in Subjects With... | NCT01029704 | Trialant
NCT01029704
Sponsor
Theracos
Status
Completed
Last Update Posted
Jun 16, 2021Actual
Enrollment
151Actual
Phase
Phase 2
Conditions
Diabetes Mellitus Type 2
Interventions
EGT0001442
Placebo capsules to match EGT0001442
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01029704
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
THR-1442-C-402
Secondary IDs
Not provided
Brief Title
Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Official Title
A Phase II, Four-week, Multi-center, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Safety and Efficacy of EGT0001442 in Subjects With Type 2 Diabetes Mellitus With an Ascending Dose Safety and Pharmacokinetic Evaluation Period
Acronym
Not provided
Organization
TheracosINDUSTRY
Status Module
Record Verification Date
Jun 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2009Actual
Primary Completion Date
Jul 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Dec 9, 2009
First Submission Date that Met QC Criteria
Dec 9, 2009
First Posted Date
Dec 10, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 21, 2011
Results First Submitted that Met QC Criteria
Jun 21, 2011
Results First Posted Date
Jul 20, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 15, 2021
Last Update Posted Date
Jun 16, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TheracosINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose after 28 days of treatment in subjects with type 2 diabetes.
The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose produced in the body by the urine.
Detailed Description
This was a phase 2 study to evaluate the efficacy of
EGT0001442. The study included two segments:
Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.
Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or placebo once daily for 28 days in an outpatient setting.
Conditions Module
Conditions
Diabetes Mellitus Type 2
Keywords
Diabetes Mellitus Type 2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
151Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
EGT0001442
Experimental
Drug: EGT0001442
Placebo
Placebo Comparator
Drug: Placebo capsules to match EGT0001442
Interventions
Name
Type
Description
Arm Group Labels
Other Names
EGT0001442
Drug
Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.
Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Pre-dose to 48 h post-dose
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
Pre-dose to 48 h post-dose
Secondary Outcomes
Measure
Description
Time Frame
Change in the Body Weight From Baseline at Week 4
Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.
Baseline and Day 29
Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female between the ages of 18 and 70 years diagnosed with type 2 diabetes.
Body mass index (BMI) between 18 kg/m2 and 37 kg/m2 (inclusive).
HbA1c levels between 6.5 and 9.5 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or HbA1c levels between 6.2 and 9.5% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1%.
Fasting plasma glucose levels between 126 and 270 mg/dL (7 - 15 mmol/L, inclusive) while on diabetic medications.
Treatment naïve subjects with HbA1c between 6.5 and 9.5 and fasting plasma glucose between 126 and 270 mg/dL (7 - 15 mmol/L).
If taking drugs for diabetes, must be medically able and willing to discontinue diabetic medications for the duration of the study.
Female subjects must be surgically sterilized or postmenopausal.
Exclusion Criteria:
Type 1 diabetes or diabetes treated with insulin injection.
Insulin therapy or oral antidiabetic medication other than metformin, sitagliptin, saxagliptin, a sulfonylurea or combination of these.
Sitting blood pressure above 150/95 mmHg on two evaluations at least 10 minutes apart at screening.
Positive results on screen for drugs of abuse.
Previous treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
Previous treatment with EGT0001474 or EGT0001442.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Mason W Freeman, M.D.
Massachusetts General Hospital
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site #10
Birmingham
Alabama
United States
Research Site #04
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
FG001
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.
Placebo
Human SGLT2 inhibitor
HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)
Baseline and Day 29
Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 and Day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (Day 1) from urinary glucose level at end of treatment (Day 28) (i.e urinary glucose level on Day 28 minus urinary glucose level on Day 1).
Baseline, Day 1 and Day 28
Change in FPG Following Cessation of Treatment
The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).
Days 27/29 to Days 41/43
National City
California
United States
Research Site #12
Denver
Colorado
United States
Research Site #07
Miami
Florida
United States
Research Site #08
Miami
Florida
United States
Research Site #06
Reading
Pennsylvania
United States
Research Site #11
DeSoto
Texas
United States
Research Site #01
San Antonio
Texas
United States
Research Site #15
San Antonio
Texas
United States
Research Site #03
Brampton
Ontario
Canada
Research Site #13
London
Ontario
Canada
Research Site #02
Mississauga
Ontario
Canada
FG002
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
FG003
Segment 1 (Dose Escalation): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
FG004
Segment 2 (Double-blind): Placebo
Received placebo once daily for 28 days
FG005
Segment 2 (Double-blind): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
FG006
Segment 2 (Double-blind): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
FG007
Segment 2 (Double-blind): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
FG008
Segment 2 (Double-blind): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
FG0005 subjects
FG0015 subjects
FG0025 subjects
FG0035 subjects
FG00428 subjects
FG00524 subjects
FG00623 subjects
FG00728 subjects
FG00826 subjects
COMPLETED
FG0005 subjects
FG0015 subjects
FG0025 subjects
FG0035 subjects
FG00423 subjects
FG00520 subjects
FG00619 subjects
FG00722 subjects
FG00825 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0054 subjects
FG0064 subjects
FG0076 subjects
FG0081 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawn due to major protocol violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
BG001
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
BG002
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
BG003
Segment 1 (Dose Escalation): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
BG004
Segment 2 (Double-blind): Placebo
Received placebo once daily for 28 days
BG005
Segment 2 (Double-blind): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
BG006
Segment 2 (Double-blind): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
BG007
Segment 2 (Double-blind): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
BG008
Segment 2 (Double-blind): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0015
BG0025
BG0035
BG00428
BG00524
BG00623
BG00728
BG00826
BG009149
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Mean
Standard Deviation
years
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG0025
ParticipantsBG003
Sex: Female, Male
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Count of Participants
Participants
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Ethnicity (NIH/OMB)
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Count of Participants
Participants
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Race (NIH/OMB)
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Count of Participants
Participants
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Height
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Mean
Standard Deviation
cm
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Weight
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Mean
Standard Deviation
kg
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
BMI
Segment 1 only applies to Dose Escalation group. Segment 2 only applies to Double-blind treatment group.
Mean
Standard Deviation
kg/m2
Title
Denominators
Categories
Segment 1
ParticipantsBG0005
ParticipantsBG0015
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Changes in Fasting Plasma Glucose (FPG) From Baseline at Week 4 for Segment 2 of the Study
Fasting glucose levels were measured at four time points; At day -2, day 1, day 27 and day 29 (24-h after the last dose). Baseline is defined as the mean of FPG values on day -2 and day 1. End of treatment is defined as the mean of FPG values on day 27 and day 29. Changes in the FPG during the study period was calculated by subtracting the Baseline FPG from End of Treatment FPG.
Subjects participated in Segment 2 of the study were included in the analysis.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline; Day -2 and Day 1. End of Treatment: Day 27 and Day 29
ID
Title
Description
OG000
Placebo
Received no drug (EGT0001442) during 28 days
OG001
EGT0001442 5mg
Received 5mg of EGT0001442 per day for 28 days
OG002
EGT0001442 10mg
Received 10mg of EGT0001442 per day for 28 days
OG003
EGT0001442 20mg
Received 20mg of EGT0001442 per day for 28 days
OG004
EGT0001442 50mg
Received 50mg of EGT0001442 per day for 28 days
Units
Counts
Participants
OG00028
OG00124
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG000-12.595± 7.025
OG001-29.518± 7.767
OG002-30.429± 8.386
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.
0.0989
P-values are from two-sided test at 5% level
Difference of LS Means
-16.923
2-Sided
95
-37.076
3.230
Superiority
OG000
Primary
Pharmacokinetics of EGT0001442 (Cmax) at 4 Dose Levels at Week 4
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.
Posted
Mean
Standard Deviation
ng/mL
Pre-dose to 48 h post-dose
ID
Title
Description
OG000
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
OG001
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
OG002
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
OG003
Segment 1 (Dose Escalation): EGT0001442 50mg
Secondary
Change in the Body Weight From Baseline at Week 4
Changes in the body weight during the study period was calculated by subtracting body weight on day 1 from body weight at the end of treatment on day 29.
Subjects participated in Segment 2 of the study were included in the analysis.
Posted
Least Squares Mean
Standard Error
Kg
Baseline and Day 29
ID
Title
Description
OG000
Placebo
Received no drug (EGT0001442) during 28 days
OG001
EGT0001442 5mg
Received 5mg of EGT0001442 per day for 28 days
OG002
EGT0001442 10mg
Received 10mg of EGT0001442 per day for 28 days
OG003
EGT0001442 20mg
Received 20mg of EGT0001442 per day for 28 days
OG004
EGT0001442 50mg
Received 50mg of EGT0001442 per day for 28 days
Secondary
Changes in Hemoglobin A1c (HbA1c) From Baseline at Week 4
HbA1c levels were measured at two time points; on day 1 and day 29 (end of treatment). Changes in the HbA1c level during the study period was calculated by subtracting HbA1c level on day 1 from HbA1c level at the end of treatment (day 29)
Subjects participated in Segment 2 of the study were included in the analysis.
Posted
Geometric Least Squares Mean
Standard Error
percentage of HbA1c
Baseline and Day 29
ID
Title
Description
OG000
Placebo
Received no drug (EGT0001442) during 28 days
OG001
EGT0001442 5mg
Received 5mg of EGT0001442 per day for 28 days
OG002
EGT0001442 10mg
Received 10mg of EGT0001442 per day for 28 days
OG003
EGT0001442 20mg
Received 20mg of EGT0001442 per day for 28 days
OG004
EGT0001442 50mg
Secondary
Change in Urinary Glucose Excretion From Baseline to Day 1 and Day 28
Urinary glucose levels were measured at three time points; on Day 0 (baseline), Day 1 and Day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (Day 1) from urinary glucose level at end of treatment (Day 28) (i.e urinary glucose level on Day 28 minus urinary glucose level on Day 1).
Only number of subjects with data available in the specific treatment group is included
Posted
Mean
Standard Deviation
g/24h
Baseline, Day 1 and Day 28
ID
Title
Description
OG000
Placebo
Received no drug (EGT0001442) during 28 days
OG001
EGT0001442 5mg
Received 5mg of EGT0001442 per day for 28 days
OG002
EGT0001442 10mg
Received 10mg of EGT0001442 per day for 28 days
OG003
EGT0001442 20mg
Received 20mg of EGT0001442 per day for 28 days
Secondary
Change in FPG Following Cessation of Treatment
The mean change in FPG following cessation of treatment was obtained by calculating the difference between FPG values obtained on End of treatment (average of FPG values on days 27 and 29) and on Post Treatment (average of FPG values on days 41 and 43).
Subjects participated in Segment 2 of the study and had fasting plasma glucose (FPG) values at the end of treatment (mean FPG value on days 27 and 29) and at post-treatment (mean FPG values on days 41 and 43) are included in the analysis.
Posted
Least Squares Mean
Standard Error
mg/dL
Days 27/29 to Days 41/43
ID
Title
Description
OG000
Placebo
Received no drug (EGT0001442) during 28 days
OG001
EGT0001442 5mg
Received 5mg of EGT0001442 per day for 28 days
OG002
EGT0001442 10mg
Received 10mg of EGT0001442 per day for 28 days
OG003
EGT0001442 20mg
Received 20mg of EGT0001442 per day for 28 days
Primary
Pharmacokinetics of EGT0001442 (AUC 0-t and 0-24) at 4 Dose Levels at Week 4
Blood samples were collected during Segment 1 at pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12 and 24 h (day 2), and 48 h (day 3) post dose for the determination of EGT0001442. Plasma concentrations of EGT0001442 were measured using a validated HPLC/MS-MS method and PK parameters were calculated by standard noncompartmental methods.
20 subjects in Segment 1 of the study were included in the analysis. The PK study was not included in Segment 2.
AUC0-24 values for two participants in 5 mg arm were not calculated.
Posted
Mean
Standard Deviation
ng*h/mL
Pre-dose to 48 h post-dose
ID
Title
Description
OG000
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
OG001
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
OG002
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
OG003
Segment 1 (Dose Escalation): EGT0001442 50mg
Time Frame
Adverse event data was collected from Day -7 (Visit 3; Washout monitor) to Day 43 (Visit 14; Termination)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Segment 1 (Dose Escalation): EGT0001442 5mg
Received 5mg of EGT0001442 once daily for 28 days
0
5
0
5
3
5
EG001
Segment 1 (Dose Escalation): EGT0001442 10mg
Received 10mg of EGT0001442 once daily for 28 days
0
5
0
5
3
5
EG002
Segment 1 (Dose Escalation): EGT0001442 20mg
Received 20mg of EGT0001442 once daily for 28 days
0
5
0
5
3
5
EG003
Segment 1 (Dose Escalation): EGT0001442 50mg
Received 50mg of EGT0001442 once daily for 28 days
0
5
0
5
2
5
EG004
Placebo
Received no drug (EGT0001442) during 28 days
0
28
0
28
4
28
EG005
EGT0001442 5mg
Received 5mg of EGT0001442 per day for 28 days
0
24
1
24
3
24
EG006
EGT0001442 10mg
Received 10mg of EGT0001442 per day for 28 days
0
23
1
23
6
23
EG007
EGT0001442 20mg
Received 20mg of EGT0001442 per day for 28 days
0
28
0
28
6
28
EG008
EGT0001442 50mg
Received 50mg of EGT0001442 per day for 28 days
0
26
0
26
6
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG0030 affected5 at risk
EG004
Thrombophlebitis superficial
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leucopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG0031 affected5 at risk
EG0040 affected28 at risk
EG0050 affected24 at risk
EG0060 affected23 at risk
EG0070 affected28 at risk
EG0080 affected26 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Scratch
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected5 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Vulvovaginal pain
Reproductive system and breast disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 12.1
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Nasal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Investigator does not have the right to publish trial results.