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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01060475




Registration number
NCT01060475
Ethics application status
Date submitted
29/01/2010
Date registered
2/02/2010
Date last updated
7/06/2010

Titles & IDs
Public title
Safety and Tolerability of LIM-0705 in Healthy Male Subjects
Scientific 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
Secondary ID [1] 0 0
LIM-0705-CL-002
Universal Trial Number (UTN)
Trial acronym
LIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LIM-0705 and tacrolimus
Treatment: Drugs - LIM-0705 and tacrolimus
Treatment: Drugs - Placebo LIM-0705 and tacrolimus
Treatment: Drugs - Drug LIM-0705 and placebo tacrolimus

Experimental: A - Low dose LIM-0705 and tacrolimus.

Experimental: B - High dose LIM-0705 and tacrolimus.

Experimental: C - Placebo LIM-0705 and tacrolimus.

Experimental: D - High dose LIM-0705 and placebo tacrolimus.


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

Treatment: Drugs: LIM-0705 and tacrolimus
Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.

Treatment: Drugs: Placebo LIM-0705 and tacrolimus
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).
Timepoint [1] 0 0
14 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network CCS-Austin - Heidelberg
Recruitment hospital [2] 0 0
Nucleus Network CCS-AMREP - Prahran
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Limerick BioPharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01060475
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Albert Frauman, MD
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01060475