Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations

• Status: Completed
• Trial end date: 2017-04-26
• Target enrollment: 0
• Participant gender: Male

Summary

This study is designed to assess and characterize the safety and tolerability profile of LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride when infiltrated into a defined area of the medial calf, and to characterize bupivacaine plasma pharmacokinetic (PK) and pharmacodynamic (PD) profiles after a single dose of LIQ865A or LIQ865B, and to determine the individual plasma concentration/time curves and mean PK parameters of each product.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Liquidia Technologies, Inc.
• Collaborator: Premier Research Group plc
• Treatments: Bupivacaine; Hyaluronic Acid

Criteria

Inclusion Criteria:

• provide written informed consent prior to enrollment

• be a non-smoking male, American Society of Anesthesiologist (ASA) physical class 1 or 2

• have a BMI between 18.5 and 25 kg. inclusive, and a weight of at least 60 kg

• be willing and able to participate for the duration of the study

• be healthy on the basis of pre-study physical examination (PE), medical history review, vital signs, lab test results as specified in the protocol

• negative urine drug test results

• negative alcohol screening test

• negative antibody test results for hepatitis B, hepatitis C, and HIV

Exclusion Criteria:

• allergic to bupivacaine, or other amide local anesthetics, or the excipients in the LIQ865 formulations or the diluent

• has taken any concomitant medications or supplements for the 3 days prior to Day 0

• has been on blood thinner or medication affecting platelet formation for the 7 days prior to Day 0

• in the opinion of the investigator, is either a hyper or hypo-responder to screening sensitivity testing

• has a history of moderate or severe renal or hepatic impairment, moderate or severe active hepatic disease, or any other clinically significant medical condition that may preclude safe study participation

• has a clinically significant test result for any screening lab parameter

• has a history or ECG screening documentation of a clinically meaningful conduction abnormality

• has scarring, tattoos, infections, or other skin changes in the area of planned study medication injection

• has known neurological disease or dysfunction (central or peripheral) that may interfere with assessments

• is unable to adequately communicate with study staff, properly give informed consent, or otherwise comply with study procedures, particularly the ability to return for outpatient follow up visits

• has participated in another interventional clinical study (investigational or marketed product) within the 30 days prior to Day 0.