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This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.
EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus.
This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects.
In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed.
This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGT0001474 | Experimental | Ascending doses of EGT0001474 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGT0001474 | Drug | Oral ascending doses given daily as capsules for up to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics results. Cmax -Maximum plasma drug concentration | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| Tmax | Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| AUC 0-t | Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t. | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| t1/2 | Pharmacokinetics results.t 1/2 - apparent terminal half life | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| AUC 0 -24 | Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose. | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| Terminal Rate Constant. | Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| CL/F | Pharmacokinetics results. Apparent oral clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mason W. Freeman, M.D. | Massachusetts General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 - Single Dose EGT0001474 2.5 mg | Treatment group - received 2.5 mg single dose of EGT0001474 |
| FG001 | Part 1 - Single Dose EGT0001474 5 mg | Treatment group- received 5 mg single dose of EGT0001474 |
| FG002 | Part 1 -Single Dose EGT0001474 10 mg | Treatment group- received 10 mg single dose of EGT0001474 |
| FG003 | Part 1 - Single Dose EGT0001474 25 mg | Treatment group- received 25 mg single dose of EGT0001474 |
| FG004 | Part 1 - Single Dose EGT0001474 75 mg | Treatment group- received 75 mg single dose of EGT0001474 |
| FG005 | Part 1 - Single Dose EGT0001474 150mg | Treatment group- received 150 mg single dose of EGT0001474 |
| FG006 | Part 1 - Single Dose Placebo | Placebo group- received single dose of placebo capsule |
| FG007 | Part 2 - Mutiple Dose EGT0001474 10 mg | Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg |
| FG008 | Part 2 - Multiple Dose EGT0001474 50 mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg |
| FG009 | Part 2 - Multiple Dose EGT0001474 150mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg |
| FG010 | Part 2 - Multiple Dose Placebo | Placebo group- received placebo capsules for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 - Single Dose EGT0001474 2.5 mg | Treatment group - received 2.5 mg single dose of EGT0001474 |
| BG001 | Part 1 - Single Dose EGT0001474 5 mg | Treatment group- received 5 mg single dose of EGT0001474 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cmax | Pharmacokinetics results. Cmax -Maximum plasma drug concentration | Posted | Aug 2010 | Mean | Standard Deviation | ng/ml | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 - Single Dose EGT0001474 2.5 mg | Treatment group - received 2.5 mg single dose of EGT0001474 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Erythema | General disorders | Non-systematic Assessment | General disorders and administrative site conditions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Di Halvorsen | Theracos | 617-726-4236 | yhalvorsen@ccib.mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Placebo to match EGT0001474 |
|
|
| Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| VZ/F | Pharmacokinetic results. Apparent volume of distribution | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
| Withdrawal by Subject |
|
| BG002 | Part 1 -Single Dose EGT0001474 10 mg | Treatment group- received 10 mg single dose of EGT0001474 |
| BG003 | Part 1 - Single Dose EGT0001474 25 mg | Treatment group- received 25 mg single dose of EGT0001474 |
| BG004 | Part 1 - Single Dose EGT0001474 75 mg | Treatment group- received 75 mg single dose of EGT0001474 |
| BG005 | Part 1 - Single Dose EGT0001474 150mg | Treatment group- received 150 mg single dose of EGT0001474 |
| BG006 | Part 1 - Single Dose Placebo | Placebo group- received single dose of placebo capsule |
| BG007 | Part 2 - Mutiple Dose EGT0001474 10 mg | Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg |
| BG008 | Part 2 - Multiple Dose EGT0001474 50 mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg |
| BG009 | Part 2 - Multiple Dose EGT0001474 150mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg |
| BG010 | Part 2 - Multiple Dose Placebo | Placebo group- received placebo capsules for 14 days |
| BG011 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
Treatment group- received 10 mg single dose of EGT0001474
| OG003 | Part 1 - Single Dose EGT0001474 25 mg | Treatment group- received 25 mg single dose of EGT0001474 |
| OG004 | Part 1 - Single Dose EGT0001474 75 mg | Treatment group- received 75 mg single dose of EGT0001474 |
| OG005 | Part 1 - Single Dose EGT0001474 150mg | Treatment group- received 150 mg single dose of EGT0001474 |
| OG006 | Part 1 - Single Dose Placebo | Placebo group- received single dose of placebo capsule |
| OG007 | Part 2 - Mutiple Dose EGT0001474 10 mg | Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg |
| OG008 | Part 2 - Multiple Dose EGT0001474 50 mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg |
| OG009 | Part 2 - Multiple Dose EGT0001474 150mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg |
| OG010 | Part 2 - Multiple Dose Placebo | Placebo group- received placebo capsules for 14 days |
|
|
| Primary | Tmax | Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups | Posted | Median | Full Range | hour | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| Primary | AUC 0-t | Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t. | Posted | Mean | Standard Deviation | ng*hr/ml | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| Primary | t1/2 | Pharmacokinetics results.t 1/2 - apparent terminal half life | Posted | Mean | Standard Deviation | hour | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| Primary | AUC 0 -24 | Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose. | Posted | Mean | Standard Deviation | ng*hr/ml | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| Primary | Terminal Rate Constant. | Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data | Posted | Mean | Standard Deviation | L/hr | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| Primary | CL/F | Pharmacokinetics results. Apparent oral clearance | Posted | Mean | Standard Deviation | L/hr | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| Primary | VZ/F | Pharmacokinetic results. Apparent volume of distribution | Posted | Mean | Standard Deviation | Liters | Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Part 1 - Single Dose EGT0001474 5 mg | Treatment group- received 5 mg single dose of EGT0001474 | 0 | 6 | 3 | 6 |
| EG002 | Part 1 -Single Dose EGT0001474 10 mg | Treatment group- received 10 mg single dose of EGT0001474 | 0 | 6 | 3 | 6 |
| EG003 | Part 1 - Single Dose EGT0001474 25 mg | Treatment group- received 25 mg single dose of EGT0001474 | 0 | 6 | 3 | 6 |
| EG004 | Part 1 - Single Dose EGT0001474 75 mg | Treatment group- received 75 mg single dose of EGT0001474 | 0 | 6 | 3 | 6 |
| EG005 | Part 1 - Single Dose EGT0001474 150mg | Treatment group- received 150 mg single dose of EGT0001474 | 0 | 6 | 3 | 6 |
| EG006 | Part 1 - Single Dose Placebo | Placebo group- received single dose of placebo capsule | 0 | 12 | 3 | 12 |
| EG007 | Part 2 - Mutiple Dose EGT0001474 10 mg | Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg | 0 | 8 | 5 | 8 |
| EG008 | Part 2 - Multiple Dose EGT0001474 50 mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg | 0 | 8 | 6 | 8 |
| EG009 | Part 2 - Multiple Dose EGT0001474 150mg | Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg | 0 | 6 | 7 | 8 |
| EG010 | Part 2 - Multiple Dose Placebo | Placebo group- received placebo capsules for 14 days | 0 | 6 | 4 | 6 |
|
| Application Site Irritation | General disorders | Non-systematic Assessment | General disorders and administrative site conditions |
|
| Asthenia | General disorders | Non-systematic Assessment | General disorders and administrative site conditions |
|
| Fatigue | General disorders | Non-systematic Assessment | General disorders and administrative site conditions |
|
| Oedema Peripheral | General disorders | Non-systematic Assessment | General disorders and administrative site conditions |
|
| Vessel puncture site haematoma | General disorders | Non-systematic Assessment | General disorders and administrative site conditions |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Head Discomfort | Nervous system disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Oropharangeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cardiac murmur | Investigations | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |