Safety and Tolerability of LIM-0705 in Healthy Male Subjects

Limerick BioPharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LIM-0705 and tacrolimus; Drug: Drug LIM-0705 and placebo tacrolimus; Drug: Placebo LIM-0705 and tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01060475

LIM-0705-CL-002

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

44 participants in 4 patient groups

A

Experimental group

Description:

Low dose LIM-0705 and tacrolimus.

Treatment:

Drug: LIM-0705 and tacrolimus

Drug: LIM-0705 and tacrolimus

B

Experimental group

Description:

High dose LIM-0705 and tacrolimus.

Treatment:

Drug: LIM-0705 and tacrolimus

Drug: LIM-0705 and tacrolimus

C

Experimental group

Description:

Placebo LIM-0705 and tacrolimus.

Treatment:

Drug: Placebo LIM-0705 and tacrolimus

D

Experimental group

Description:

High dose LIM-0705 and placebo tacrolimus.

Treatment:

Drug: Drug LIM-0705 and placebo tacrolimus