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Safety and Tolerability of LIM-0705 in Healthy Male Subjects

L

Limerick BioPharma

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LIM-0705 and tacrolimus
Drug: Drug LIM-0705 and placebo tacrolimus
Drug: Placebo LIM-0705 and tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01060475
LIM-0705-CL-002

Details and patient eligibility

About

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

Enrollment

44 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

44 participants in 4 patient groups

A
Experimental group
Description:
Low dose LIM-0705 and tacrolimus.
Treatment:
Drug: LIM-0705 and tacrolimus
Drug: LIM-0705 and tacrolimus
B
Experimental group
Description:
High dose LIM-0705 and tacrolimus.
Treatment:
Drug: LIM-0705 and tacrolimus
Drug: LIM-0705 and tacrolimus
C
Experimental group
Description:
Placebo LIM-0705 and tacrolimus.
Treatment:
Drug: Placebo LIM-0705 and tacrolimus
D
Experimental group
Description:
High dose LIM-0705 and placebo tacrolimus.
Treatment:
Drug: Drug LIM-0705 and placebo tacrolimus

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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