FindTrial
Sign In

Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes

A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of EGT0001474 in Subjects With Type 2 Diabetes

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00924053
Enrollment
24
Registered
2009-06-18
Start date
2009-06-30
Completion date
2009-07-31
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2

Brief summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how much of the drug gets into the blood and how long it takes the body to get rid of it) of single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.

Detailed description

EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. This would help prevent an abnormal decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing insulin secretion (which may result in weight gain or an abnormal increase in blood sugar known as Type 2 diabetes).

Interventions

DRUGEGT0001474

Cohort 1: single dose of 25 mg EGT0001474 given as an oral capsule; Cohort 2: single dose of 75 mg EGT0001474 given as 3 oral capsules; Cohort 3: single dose of 150 mg EGT0001474 given as 6 oral capsules.

DRUGPlacebo

Placebo capsules to match EGT0001474

Sponsors

Theracos
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes. * Body mass Index (BMI) between 18 kg/m2 and 37 kg/m2. * HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive) while on diabetic medications. * If taking drugs for diabetes, must be medically able and willing to discontinue diabetes medications for the duration of the study. * Female subjects must be surgically sterilized or postmenopausal. * Non-smoker for at least 3 months. * Negative alcohol screen.

Exclusion criteria

* Type 1 diabetes. * Use of insulin therapy or oral antidiabetic medication other than metformin, sitagliptin or a sulfonylurea. * Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at screening. * Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer. * Previous treatment with EGT0001474. * Vaccination within 30 days prior to the first dose of study medication.

Design outcomes

Primary

MeasureTime frameDescription
Safety and Tolerability of EGT000147425 daysSafety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.
AUC 0-t3 daysArea under the plasma concentration-time curve from time 0 to time t
AUC0-243 daysArea under the plasma concentration-time curve from time 0 to hour 24
AUC Inf3 daysArea under the plasma concentration-time curve from time 0 to infinity
Cmax3 daysMaximum plasma concentration
Tmax3 daysTime of maximum plasma concentration
λz3 daysTerminal phase rate constant
t1/23 daysApparent terminal half life
CL/F3 daysThe apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.
Vz/F3 daysApparent volume of distribution

Countries

United States

Participant flow

Recruitment details

The first subject was enrolled on 12 Jun 2009; the last subject was completed on 28 Jul 2009. Subjects participated at a CRO in San Antonio, TX.

Pre-assignment details

For 3 weeks after enrollment and prior to assignment to treatment and receiving drug, subjects were screened (informed consent, medical history, vital signs, electrocardiogram, laboratory test results, and screening for drugs of abuse and alcohol use) and began a 14 day washout period (counseling, review of medications and adverse events).

Participants by arm

ArmCount
Placebo
Received 1, 3, or 6 placebo capsules once daily.
6
EGT0001474 25 mg
Received one 25 mg capsule once daily.
6
EGT0001474 75 mg
Received three 25mg capsules once daily.
6
EGT0001474 150mg
Received six 25 mg capsules once daily.
6
Total24

Baseline characteristics

CharacteristicPlaceboEGT0001474 25 mgEGT0001474 75 mgEGT0001474 150mgTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants6 Participants6 Participants6 Participants24 Participants
Sex: Female, Male
Female
2 Participants3 Participants4 Participants3 Participants12 Participants
Sex: Female, Male
Male
4 Participants3 Participants2 Participants3 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
2 / 60 / 64 / 62 / 6
serious
Total, serious adverse events
0 / 60 / 60 / 60 / 6

Outcome results

Primary

AUC0-24

Area under the plasma concentration-time curve from time 0 to hour 24

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboAUC0-24NA ng*hr/mL—
EGT0001474 25 mgAUC0-24987.3 ng*hr/mLStandard Deviation 368.21
EGT0001474 75 mgAUC0-242990.63 ng*hr/mLStandard Deviation 461.18
EGT0001474 150mgAUC0-245584.72 ng*hr/mLStandard Deviation 1516.64
Primary

AUC 0-t

Area under the plasma concentration-time curve from time 0 to time t

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboAUC 0-tNA ng*hr/mL—
EGT0001474 25 mgAUC 0-t1103.89 ng*hr/mLStandard Deviation 470.31
EGT0001474 75 mgAUC 0-t3370.29 ng*hr/mLStandard Deviation 499.36
EGT0001474 150mgAUC 0-t6177.8 ng*hr/mLStandard Deviation 1691.04
Primary

AUC Inf

Area under the plasma concentration-time curve from time 0 to infinity

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboAUC InfNA ng*hr/mL—
EGT0001474 25 mgAUC Inf1165.59 ng*hr/mLStandard Deviation 479.88
EGT0001474 75 mgAUC Inf3532.02 ng*hr/mLStandard Deviation 524.74
EGT0001474 150mgAUC Inf6399.55 ng*hr/mLStandard Deviation 1736.38
Primary

CL/F

The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboCL/FNA mL/hr—
EGT0001474 25 mgCL/F24479.26 mL/hrStandard Deviation 9146.52
EGT0001474 75 mgCL/F21616.42 mL/hrStandard Deviation 3112.38
EGT0001474 150mgCL/F24996.33 mL/hrStandard Deviation 7009.45
Primary

Cmax

Maximum plasma concentration

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboCmaxNA ng/mL—
EGT0001474 25 mgCmax157.23 ng/mLStandard Deviation 76.25
EGT0001474 75 mgCmax518.67 ng/mLStandard Deviation 176.36
EGT0001474 150mgCmax1014 ng/mLStandard Deviation 372.63
Primary

Safety and Tolerability of EGT0001474

Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.

Time frame: 25 days

Population: All patients who took study medication were included in the analysis.

ArmMeasureGroupValue (NUMBER)
PlaceboSafety and Tolerability of EGT0001474Mild adverse events5 Events
PlaceboSafety and Tolerability of EGT0001474Serious adverse events0 Events
PlaceboSafety and Tolerability of EGT0001474Moderate adverse events0 Events
EGT0001474 25 mgSafety and Tolerability of EGT0001474Mild adverse events0 Events
EGT0001474 25 mgSafety and Tolerability of EGT0001474Serious adverse events0 Events
EGT0001474 25 mgSafety and Tolerability of EGT0001474Moderate adverse events0 Events
EGT0001474 75 mgSafety and Tolerability of EGT0001474Moderate adverse events0 Events
EGT0001474 75 mgSafety and Tolerability of EGT0001474Mild adverse events9 Events
EGT0001474 75 mgSafety and Tolerability of EGT0001474Serious adverse events0 Events
EGT0001474 150mgSafety and Tolerability of EGT0001474Mild adverse events3 Events
EGT0001474 150mgSafety and Tolerability of EGT0001474Serious adverse events0 Events
EGT0001474 150mgSafety and Tolerability of EGT0001474Moderate adverse events1 Events
Primary

t1/2

Apparent terminal half life

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
Placebot1/2NA hour—
EGT0001474 25 mgt1/210.1 hourStandard Deviation 3.21
EGT0001474 75 mgt1/212.18 hourStandard Deviation 3.88
EGT0001474 150mgt1/212.15 hourStandard Deviation 3.94
Primary

Tmax

Time of maximum plasma concentration

Time frame: 3 days

ArmMeasureValue (MEDIAN)
PlaceboTmaxNA hour
EGT0001474 25 mgTmax3 hour
EGT0001474 75 mgTmax2 hour
EGT0001474 150mgTmax2 hour
Primary

Vz/F

Apparent volume of distribution

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboVz/FNA mL—
EGT0001474 25 mgVz/F348376.12 mLStandard Deviation 15666.55
EGT0001474 75 mgVz/F382783.75 mLStandard Deviation 138953.19
EGT0001474 150mgVz/F435944.78 mLStandard Deviation 179821.44
Primary

λz

Terminal phase rate constant

Time frame: 3 days

ArmMeasureValue (MEAN)Dispersion
PlaceboλzNA 1/hour—
EGT0001474 25 mgλz0.0741 1/hourStandard Deviation 0.0215
EGT0001474 75 mgλz0.0613 1/hourStandard Deviation 0.0168
EGT0001474 150mgλz0.0622 1/hourStandard Deviation 0.0195

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026