Safety and Tolerability of LIM-0705 in Healthy Male Subjects
LIM
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
1 other identifier
interventional
44
1 country
2
Brief Summary
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Feb 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJune 7, 2010
June 1, 2010
3 months
January 29, 2010
June 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
14 days
Secondary Outcomes (1)
Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).
14 days
Study Arms (4)
A
EXPERIMENTALLow dose LIM-0705 and tacrolimus.
B
EXPERIMENTALHigh dose LIM-0705 and tacrolimus.
C
EXPERIMENTALPlacebo LIM-0705 and tacrolimus.
D
EXPERIMENTALHigh dose LIM-0705 and placebo tacrolimus.
Interventions
Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nucleus Network CCS-Austin
Heidelberg, Victoria, 3084, Australia
Nucleus Network CCS-AMREP
Prahran, Victoria, 3181, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Albert Frauman, MD
Nucleus Network
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 2, 2010
Study Start
February 1, 2010
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
June 7, 2010
Record last verified: 2010-06