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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
History of Changes

January 29, 2010
June 4, 2010
February 2010
May 2010   (final data collection date for primary outcome measure)
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus). [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01060475 on ClinicalTrials.gov Archive Site
Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus). [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • 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.
  • Experimental: A
    Low dose LIM-0705 and tacrolimus.
    Intervention: Drug: LIM-0705 and tacrolimus
  • Experimental: B
    High dose LIM-0705 and tacrolimus.
    Intervention: Drug: LIM-0705 and tacrolimus
  • Experimental: C
    Placebo LIM-0705 and tacrolimus.
    Intervention: Drug: Placebo LIM-0705 and tacrolimus
  • Experimental: D
    High dose LIM-0705 and placebo tacrolimus.
    Intervention: Drug: Drug LIM-0705 and placebo tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01060475
LIM-0705-CL-002
Yes
Wendye Rae Robbins, MD, Limerick BioPharma
Limerick BioPharma
Not Provided
Study Director: Albert Frauman, MD Nucleus Network
Limerick BioPharma
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP