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
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, see Learn About Clinical Studies.

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 October 01, 2014