Safety and Tolerability of LIM-0705 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Limerick BioPharma
• Treatments: 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