NCT02106585

Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects

Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	JTT-251 or Placebo	Subjects will receive JTT-251 or Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-04-08
• Last updated: 2014-10-07

Locations

1 site across 1 country: United States