NCT01511900

A Multiple Ascending Dose Study of CAT-1004 in Patients With Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAT-1004 in Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Catabasis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the safety of escalating multiple doses over 2 weeks of CAT 1004 compared to placebo in patients with Type 2 diabetes (T2D). Secondary objectives include evaluation of the pharmacokinetics (PK) and pharmacodynamics of escalating multiple doses of CAT-1004 in patients with T2D.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	CAT 1004	Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004
DRUG	Placebo	Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
DRUG	CAT 1004	Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004
DRUG	CAT 1004	Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004
DRUG	CAT 1004	Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004
DRUG	CAT 1004	Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-01-19
• Last updated: 2012-06-08

Locations

1 site across 1 country: United States