Safety and Tolerability of LIM-0705 in Healthy Male Subjects

Healthy Clinical Trial

— LIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060475
• Other study ID #: LIM-0705-CL-002
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2010
• Last updated: June 4, 2010
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Limerick BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LIM-0705 and tacrolimus
Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
• LIM-0705 and tacrolimus
Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
• Placebo LIM-0705 and tacrolimus
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
• 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.

Locations

Country	Name	City	State
Australia	Nucleus Network CCS-Austin	Heidelberg	Victoria
Australia	Nucleus Network CCS-AMREP	Prahran	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Limerick BioPharma

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).		14 days	Yes
Secondary	Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).		14 days	No