Clinical trial NCT00854113: Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers
Official title: A Phase I , Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of EGT0001474 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety and Tolerability of EGT0001474 in Healthy Volunteers
Keywords: Diabetes Mellitus Type 2
Lead sponsor: Theracos
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Cmax
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: Tmax
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: AUC 0-t
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: t1/2
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: AUC 0 -24
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: Terminal Rate Constant.
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: CL/F
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
measure: VZ/F
timeFrame: Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Massachusetts General Hospital
name: Mason W. Freeman, M.D.
role: STUDY_CHAIR
References: