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A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes

NCT01474083 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2013-09-13

No results posted yet for this study

Summary

The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.

Conditions

Interventions

DRUG

GK1-399 (formerly TTP399)

Treatment A: GK1-399 200 mg. Oral administration, twice per day.

DRUG

GK1-399 (formerly TTP399)

Treatment B: GK1-399 800 mg. Oral administration, once per day.

DRUG

GK1-399 (formerly TTP399)

Treatment C: GK1-399 800 mg. Oral administration, twice per day.

DRUG

Placebo

Dose-matched placebo. Oral administration.

Sponsors & Collaborators

  • vTv Therapeutics

    lead INDUSTRY

Principal Investigators

  • Aaron Burstein, Pharm.D. · TransTech Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474083 on ClinicalTrials.gov