Safety and Tolerability of LIM-0705 in Healthy Male Subjects
NCT ID: NCT01060475
Last Updated: 2010-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2010-02-28
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Low dose LIM-0705 and tacrolimus.
LIM-0705 and tacrolimus
Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
B
High dose LIM-0705 and tacrolimus.
LIM-0705 and tacrolimus
Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
C
Placebo LIM-0705 and tacrolimus.
Placebo LIM-0705 and tacrolimus
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
D
High dose LIM-0705 and placebo tacrolimus.
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.
Interventions
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LIM-0705 and tacrolimus
Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
LIM-0705 and tacrolimus
Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
Placebo LIM-0705 and tacrolimus
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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Limerick BioPharma
INDUSTRY
Responsible Party
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Limerick BioPharma
Principal Investigators
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Albert Frauman, MD
Role: STUDY_DIRECTOR
Nucleus Network
Locations
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Nucleus Network CCS-Austin
Heidelberg, Victoria, Australia
Nucleus Network CCS-AMREP
Prahran, Victoria, Australia
Countries
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Other Identifiers
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LIM-0705-CL-002
Identifier Type: -
Identifier Source: org_study_id
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