Safety and Tolerability of LIM-0705 in Healthy Male Subjects

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LIM-0705 and tacrolimus
* Drug: LIM-0705 and tacrolimus
* Drug: Placebo LIM-0705 and tacrolimus
* Drug: Drug LIM-0705 and placebo tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Low dose LIM-0705 and tacrolimus. | Drug: LIM-0705 and tacrolimus<br>* Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.<br>|
| Experimental: B<br>High dose LIM-0705 and tacrolimus. | Drug: LIM-0705 and tacrolimus<br>* Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.<br>|
| Experimental: C<br>Placebo LIM-0705 and tacrolimus. | Drug: Placebo LIM-0705 and tacrolimus<br>* Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.<br>|
| Experimental: D<br>High dose LIM-0705 and placebo tacrolimus. | Drug: Drug LIM-0705 and placebo tacrolimus<br>* Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus). |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus). |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant