Trial | NCT01060475  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tacrolimus lim-0705 ...

  • Study Participants

    44
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
Study Started
Feb 28
2010
Primary Completion
May 31
2010
Study Completion
Jun 30
2010
Last Update
Jun 07
2010
Estimate

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.

A Experimental

Low dose LIM-0705 and tacrolimus.

B Experimental

High dose LIM-0705 and tacrolimus.

C Experimental

Placebo LIM-0705 and tacrolimus.

D Experimental

High dose LIM-0705 and placebo tacrolimus.

Criteria 

Inclusion Criteria:

Male age 18-50
Patient in good health as deemed by pre-study exam and history
BMI 20-30 kg/sq. meter
Absence of tremors
Must be willing to remain in confinement for 17 days/16 nights
Systolic BP 90-140 mmHg, diastolic BP 50-90 mmHg, resting HR 45-90 bpm
Subject must be non-smoker or willing to abstain from smoking day -4 through day 30.
Subject must abstain from alcohol, grapefruit,and caffeine-containing beverages starting Day -2 through Day 30.
Subjects must use double-barrier contraception through course of study + 90 days following study

Exclusion Criteria:

Allergy to red wine or onions
Strict vegetarians
Use of any non-study medication
Use of chemotherapy within 5 years prior to Screening visit
Use of any dietary aids
Difficultly swallowing oral medications
cognitive or psychiatric disorders
No Results Posted