Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming months in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01060475
Ethics application status
Date submitted
29/01/2010
Date registered
1/02/2010
Date last updated
4/06/2010

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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