Acute Pain Clinical Trial
Official title:
A Phase 1 Randomized, Controlled, Double-Blind, Single Ascending Dose Safety and Pharmacokinetic/Pharmacodynamic Study in Healthy Adult Males After LIQ865 Injection
Verified date | August 2017 |
Source | Liquidia Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | April 26, 2017 |
Est. primary completion date | March 23, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | DanTrial Aps | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Liquidia Technologies, Inc. | Premier Research Group plc |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment Emergent Adverse Events (AEs) | Safety assessments will include the incidence and severity of AEs during treatment and the follow-up period of the study | 30 days | |
Secondary | Pharmacokinetic - Area under the plasma concentration curve from time zero to Day 5 | Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment | ||
Secondary | Pharmacokinetic - Cmax (ng/mL) | Maximum plasma concentration over the entire sampling period, directly obtained from the experimental data of plasma concentration versus time curves, without interpolation. | Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment | |
Secondary | Pharmacokinetic - Tmax (h) | Time to reach maximum plasma concentration | Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment | |
Secondary | Pharmacokinetic - t1/2 (h) | Apparent terminal elimination half-life | Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment | |
Secondary | Pharmacokinetic - CST1/2 (h) | Context-sensitive half-time measured from Tmax to time for plasma concentration to reach half of Cmax following study medication injection. | Timepoints (draws) at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours and 2, 3, 4, 5 days after treatment | |
Secondary | Pharmacodynamic Response - Pain intensity (Numeric Rating Scale) with Short Tonic Heat Stimulus (STHS) testing at various time points | Testing done to calculate time-weighted Sum of Pain Intensity Differences (SPID) at the time points noted, compared to Baseline, and time specific SPID results | 1, 2, 12, 24, 48, 72, 96, and 120 hours | |
Secondary | Pharmacodynamic Response - Change in Mechanical Pain Threshold (MPT) compared to Baseline using various time points | Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120 | 12, 24, 48, 72, 96, and 120 hours | |
Secondary | Pharmacodynamic Response - Change in Heat Pain Threshold (HPT) compared to Baseline using various time points | Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120 | 12, 24, 48, 72, 96, and 120 hours | |
Secondary | Pharmacodynamic Response - Change Mechanical Detection Threshold (MDT) compared to Baseline using various time points | Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120 | 12, 24, 48, 72, 96, and 120 hours | |
Secondary | Pharmacodynamic Response - Change in Warmth Detection Threshold (WDT) compared to Baseline using various time points | Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120 | 12, 24, 48, 72, 96, and 120 hours | |
Secondary | Pharmacodynamic Response - Change in Cold Detection Threshold (CDT) compared to Baseline using various time points | Calculate the time-weighted sum of threshold differences (calculated as area-under-the-curve (AUC): AUC12, AUC24, AUC48, AUC72, AUC96, AUC120 | 12, 24, 48, 72, 96, and 120 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04484610 -
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
|
Phase 4 | |
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT03825549 -
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
|
N/A | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Recruiting |
NCT05589246 -
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
|
N/A | |
Recruiting |
NCT05572190 -
Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
|
Phase 1 | |
Terminated |
NCT04716413 -
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
|
Phase 4 | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Not yet recruiting |
NCT06317844 -
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
|
N/A | |
Withdrawn |
NCT02957097 -
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
|
Phase 4 | |
Completed |
NCT02565342 -
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
|
Phase 4 | |
Terminated |
NCT02599870 -
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
|
N/A | |
Completed |
NCT02984098 -
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
|
Phase 4 | |
Completed |
NCT02380989 -
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
|
Phase 2 | |
Completed |
NCT02489630 -
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
|
Phase 4 | |
Completed |
NCT03107338 -
Preventive Treatment of Pain After Dental Implant Surgery
|
Phase 4 | |
Completed |
NCT02817477 -
Intranasal Ketamine for Acute Traumatic Pain
|
Phase 4 |