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Safety and Tolerability of LIM-0705 in Healthy Male Subjects

NCT01060475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-06-07

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

LIM-0705 and tacrolimus

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

DRUG

LIM-0705 and tacrolimus

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

DRUG

Placebo LIM-0705 and tacrolimus

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

DRUG

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.

Sponsors & Collaborators

  • Limerick BioPharma

    lead INDUSTRY

Principal Investigators

  • Albert Frauman, MD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060475 on ClinicalTrials.gov