Safety and Tolerability of LIM-0705 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Limerick BioPharma
ClinicalTrials.gov Identifier:
NCT01060475
First received: January 29, 2010
Last updated: June 4, 2010
Last verified: June 2010
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus). [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Wendye Rae Robbins, MD, Limerick BioPharma
ClinicalTrials.gov Identifier: NCT01060475     History of Changes
Other Study ID Numbers: LIM-0705-CL-002
Study First Received: January 29, 2010
Last Updated: June 4, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Limerick BioPharma:
Transplant

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014