Safety and Tolerability of LIM-0705 in Healthy Male Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01060475

Acronym

LIM

Enrollment

Registered

2010-02-02

Start date

2010-02-28

Completion date

2010-06-30

Last updated

2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Transplant

Brief summary

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

Interventions

DRUGLIM-0705 and tacrolimus

Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.

DRUGPlacebo LIM-0705 and tacrolimus

Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.

DRUGDrug LIM-0705 and placebo tacrolimus

Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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 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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026