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OpenTrials
Completed

NCT Number: NCT01060475

Safety and Tolerability of LIM-0705 in Healthy Male Subjects

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network CCS-Austin, Heidelberg, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIM-0705 and tacrolimus

Drug

Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.

Placebo LIM-0705 and tacrolimus

Drug

Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.

Drug LIM-0705 and placebo tacrolimus

Drug

Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.

Primary outcomes

  1. Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).

    Time frame: 14 days

Secondary outcomes

  1. Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Limerick BioPharma

Industry

Registry information

Official study 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

Acronym: LIM

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 2, 2010
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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