NCT01060475CompletedPhase 1
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
Limerick BioPharma2 sites in 1 country44 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
Study Overview
Brief Summary
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- •Subject must abstain from alcohol, grapefruit,and caffeine-containing beverages starting Day -2 through Day
- •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
Arms & Interventions
A
Experimental
Low dose LIM-0705 and tacrolimus.
Intervention: LIM-0705 and tacrolimus (Drug)
B
Experimental
High dose LIM-0705 and tacrolimus.
Intervention: LIM-0705 and tacrolimus (Drug)
C
Experimental
Placebo LIM-0705 and tacrolimus.
Intervention: Placebo LIM-0705 and tacrolimus (Drug)
D
Experimental
High dose LIM-0705 and placebo tacrolimus.
Intervention: Drug LIM-0705 and placebo tacrolimus (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
Time Frame: 14 days
Secondary Outcomes
- Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).(14 days)
Investigators
Study Sites (2)
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