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Safety and Tolerability of LIM-0705 in Healthy Male Subjects (LIM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060475
First Posted: February 2, 2010
Last Update Posted: June 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Limerick BioPharma
  Purpose
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.

Condition Intervention Phase
Healthy Drug: LIM-0705 and tacrolimus Drug: Placebo LIM-0705 and tacrolimus Drug: Drug LIM-0705 and placebo tacrolimus Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Limerick BioPharma:

Primary Outcome Measures:
  • Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus). [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus). [ Time Frame: 14 days ]

Enrollment: 44
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Low dose LIM-0705 and tacrolimus.
Drug: LIM-0705 and tacrolimus
Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
Experimental: B
High dose LIM-0705 and tacrolimus.
Drug: LIM-0705 and tacrolimus
Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
Experimental: C
Placebo LIM-0705 and tacrolimus.
Drug: Placebo LIM-0705 and tacrolimus
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
Experimental: D
High dose LIM-0705 and placebo tacrolimus.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060475


Locations
Australia, Victoria
Nucleus Network CCS-Austin
Heidelberg, Victoria, Australia, 3084
Nucleus Network CCS-AMREP
Prahran, Victoria, Australia, 3181
Sponsors and Collaborators
Limerick BioPharma
Investigators
Study Director: Albert Frauman, MD Nucleus Network
  More Information

Responsible Party: Wendye Rae Robbins, MD, Limerick BioPharma
ClinicalTrials.gov Identifier: NCT01060475     History of Changes
Other Study ID Numbers: LIM-0705-CL-002
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: June 7, 2010
Last Verified: June 2010

Keywords provided by Limerick BioPharma:
Transplant

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action