HealthyPhase 1LIMNCT01060475
Safety and Tolerability of LIM-0705 in Healthy Male Subjects
A Phase 1 study testing LIM-0705 and tacrolimus in people with Healthy, run by Limerick BioPharma at 2 sites in Australia.
Trial summary
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LIM-0705 and tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2010to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Nucleus Network CCS-Austin
Heidelberg, Victoria, 3084
Nucleus Network CCS-AMREP
Prahran, Victoria, 3181
About this study
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
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
- Conditions
- Healthy
- Being tested
- LIM-0705 and tacrolimus, Placebo LIM-0705 and tacrolimus, Drug LIM-0705 and placebo tacrolimus
- Keywords
- Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIM-0705 and tacrolimusDrug
Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.
LIM-0705 and tacrolimusDrug
Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.
Placebo LIM-0705 and tacrolimusDrug
Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.
Drug LIM-0705 and placebo tacrolimusDrug
Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Low dose LIM-0705 and tacrolimus. Receives: Drug: LIM-0705 and tacrolimus |
| B | Experimental | High dose LIM-0705 and tacrolimus. Receives: Drug: LIM-0705 and tacrolimus |
| C | Experimental | Placebo LIM-0705 and tacrolimus. Receives: Drug: Placebo LIM-0705 and tacrolimus |
| D | Experimental | High dose LIM-0705 and placebo tacrolimus. Receives: Drug: Drug LIM-0705 and placebo tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
Measured: 14 days
Secondary outcomes (1)
Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limerick BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Albert Frauman, MD, Study director, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060475
- Sponsor's protocol ID
- LIM-0705-CL-002
- Acronym
- LIM
- Status last verified
- Jun 2010
- First submitted
- 29 Jan 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01060475
- Acronym / sponsor ID
- LIM / LIM-0705-CL-002
- Conditions
- Healthy
- Keywords
- Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Limerick BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: LIM-0705 and tacrolimusLow dose LIM-0705 and tacrolimus. |
| B | Experimental | Drug: LIM-0705 and tacrolimusHigh dose LIM-0705 and tacrolimus. |
| C | Experimental | Drug: Placebo LIM-0705 and tacrolimusPlacebo LIM-0705 and tacrolimus. |
| D | Experimental | Drug: Drug LIM-0705 and placebo tacrolimusHigh dose LIM-0705 and placebo tacrolimus. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIM-0705 and tacrolimusOral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days. | Drug | A |
| LIM-0705 and tacrolimusOral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days. | Drug | B |
| Placebo LIM-0705 and tacrolimusPlacebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days. | Drug | C |
| Drug LIM-0705 and placebo tacrolimusOral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days. | Drug | D |
Primary outcome
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus).
Time frame: 14 days
1 secondary outcome
Pharmacokinetics of LIM-0705 with and without combination of co-administered drug (tacrolimus).
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Frauman, MD study director
Nucleus Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIM-0705 and tacrolimus in people with Healthy, run by Limerick BioPharma at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of LIM-0705 with and without co-administered drug (tacrolimus). (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.