Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers - Full Text View

Purpose

This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.

Condition	Intervention	Phase
Safety and Tolerability of EGT0001474 in Healthy Volunteers	Drug: EGT0001474 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase I , Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of EGT0001474 In Healthy Volunteers

Further study details as provided by Theracos:

Primary Outcome Measures:

Cmax [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results. Cmax -Maximum plasma drug concentration
Tmax [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups
AUC 0-t [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.
t1/2 [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results.t 1/2 - apparent terminal half life
AUC 0 -24 [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Terminal Rate Constant. [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data
CL/F [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetics results. Apparent oral clearance
VZ/F [ Time Frame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days ] [ Designated as safety issue: Yes ]
Pharmacokinetic results. Apparent volume of distribution

Enrollment:	78
Study Start Date:	February 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: EGT0001474 Ascending doses of EGT0001474	Drug: EGT0001474 Oral ascending doses given daily as capsules for up to 14 days Other Name: Human SGLT2 inhibitor
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo to match EGT0001474 Other Name: Human SGLT2 inhibitor

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female volunteers between the ages of 18 and 55 years inclusive.
In good health.
Female subjects must be surgically sterilized or postmenopausal.
Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
Non-smoker.
Negative drug and alcohol screens.

Exclusion Criteria:

Abnormal ECG
Sitting blood pressure above 140/90 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.
History of drug abuse.
Febrile illness within 5 days prior to the first dose of study medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854113

Locations

United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704

Sponsors and Collaborators

Theracos

Investigators

Study Chair:

Mason W. Freeman, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Albert Collinson Ph.D, President and CEO, Theracos
ClinicalTrials.gov Identifier:	NCT00854113 History of Changes
Other Study ID Numbers:	THR-1474-C-328
Study First Received:	February 27, 2009
Results First Received:	October 25, 2010
Last Updated:	July 18, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theracos:

Diabetes Mellitus Type 2

ClinicalTrials.gov processed this record on May 22, 2013