Safety and Tolerability of LIM-0705 in Healthy Male Subjects | NCT01060475

Studies
Safety and Tolerability of LIM-0705 in Healthy Male Subjects

NCT01060475

Sponsor

Limerick BioPharma

Status

Completed

Last Update Posted

Jun 7, 2010Estimated

Enrollment

44Actual

Phase

Phase 1

Conditions

Healthy

Interventions

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

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jan 29, 2010

First Submission Date that Met QC Criteria

Feb 1, 2010

First Posted Date

Feb 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2010

Last Update Posted Date

Jun 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Low dose LIM-0705 and tacrolimus.	Drug: LIM-0705 and tacrolimus
B	Experimental	High dose LIM-0705 and tacrolimus.	Drug: LIM-0705 and tacrolimus
C	Experimental	Placebo LIM-0705 and tacrolimus.	Drug: Placebo LIM-0705 and tacrolimus
D	Experimental	High dose LIM-0705 and placebo tacrolimus.	Drug: Drug LIM-0705 and placebo tacrolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LIM-0705 and tacrolimus	Drug	Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).		14 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Albert Frauman, MD	Nucleus Network	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network CCS-Austin		Heidelberg	Victoria	3084	Australia
Nucleus Network CCS-AMREP

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided