NCT01060475

Safety and Tolerability of LIM-0705 in Healthy Male Subjects

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of LIM-0705 Given With or Without Tacrolimus in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Limerick BioPharma · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LIM-0705 and tacrolimus	Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
DRUG	LIM-0705 and tacrolimus	Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
DRUG	Placebo LIM-0705 and tacrolimus	Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
DRUG	Drug LIM-0705 and placebo tacrolimus	Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2010-02-02
• Last updated: 2010-06-07

Locations

2 sites across 1 country: Australia