- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160067
A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches
September 29, 2014 updated by: Mundipharma Research Limited
A Four-period, Randomised, Open-label, Crossover, Pharmacokinetic Study to Assess the Dose Proportionality and Relative Bioavailability of Buprenorphine Transdermal Delivery System Second Generation Patches Compared to First Generation Patches, in Healthy Volunteers
The purpose of this study is to obtain pharmacokinetic data for a dose proportionality and relative bioavailability assessment of 2nd generation BTDS patches compared to 1st generation BTDS patches.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective is to examine a new 2nd generation BTDS patch formulation at 2 strengths: 3.15 mg and 12.6 mg, compared to 1st generation patches at 2 strengths: 5 mg and 20 mg, to assess dose proportionality and relative bioavailability before proceeding to a definitive program of studies.
Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 288 hours post-patch application.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nottingham, United Kingdom
- Quotient Clinical LTD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- Provide written informed consent.
- Healthy male or female subjects aged 18 to 55 inclusive.
- Female subjects of child bearing potential must be willing to use two highly effective methods of contraception throughout the study, one of which must include a barrier method. .
- Male subjects who are willing to use contraception with their partners throughout the study and for 30 days after completion of the study and agree to inform the Investigator if their partner becomes pregnant during this time.
- Body weight ranging from 55 to 100 kg and a BMI ≥ 18.5 and ≤ 29.9.
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
- Willing to eat all the food supplied throughout the study.
- The subject's primary care physician has confirmed within the last 12 months that there is nothing in the subject's medical history that would preclude their enrolment into a clinical study.
- Will refrain from strenuous exercise during the entire study.
Exclusion criteria
- Female subjects who are pregnant or lactating.
- Any history of drug or alcohol abuse.
- Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of opioid or opioid antagonist-containing medication in the past 30 days.
- Any history of frequent nausea or vomiting regardless of aetiology.
- Any history of seizures or symptomatic head trauma.
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study, participation in the previous Mundipharma Research Ltd, BUP1505 study or participation in any other study during this study.
- Any significant illness during the 4 weeks preceding entry into this study.
- A history of additional risk factors for Torsades de Pointes (e.g. heart failure, hypokalaemia, personal or family history of long QT syndrome, syncope, or family history of sudden death).
- Abnormal cardiac conditions including any of the following:
- Use of medication within 5 times the half-life or minimum 14 days for prescription medication or 7 days for over-the-counter preparations (including vitamins, herbal and/or mineral supplements), whichever is longer, before the first dose of study treatment and during the study (with the exception of the continued use of HRT and contraceptives).
- Refusal to abstain from caffeine or xanthine containing beverages and grapefruit juice within 48 hours before IMP administration until after the last study PK sample has been taken in each study period.
- Weekly alcohol intake exceeding the equivalent of 14 units/week for females and 21 units/week for males.
- Consumption of alcoholic beverages within 48 hours before IMP administration, and refusal to abstain from alcohol for the duration of the study confinement and for at least 48 hours after the last naltrexone dose in each study period.
- History of smoking within 45 days of IMP administration and refusal to abstain from smoking during the study.
- Blood or blood products donated within 90 days prior to IMP administration or any time during the study, except as required by this protocol.
- Positive results of urine drug screen, alcohol test, pregnancy test, HBsAg, Hepatitis C antibody, or HIV tests.
- Known sensitivity to buprenorphine, naltrexone, related compounds or any of the excipients or any contraindications as detailed in the Butrans Summary of Product Characteristics or Nalorex Summary of Product Characteristics.
- Clinically significant history of allergic reaction to wound dressings or elastoplast.
- Subjects with any dermatological disorder or tattoos at the proposed sites of patch application, or with a history of eczema/cutaneous atrophy.
- Subjects who will not allow hair to be removed at the proposed patch application sites which may prevent proper placement of the patch.
- Refusal to allow their primary care physician to be informed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment A
Second generation patch BTDS 12.6mg
|
|
EXPERIMENTAL: Treatment B
Second generation patch BTDS 3.15mg
|
|
ACTIVE_COMPARATOR: Treatment C
First generation patch BuTrans 20mg
|
|
ACTIVE_COMPARATOR: Treatment D
First generation patch BuTrans 5mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics parameters
Time Frame: Up to 288 hours
|
AUC and Cmax
|
Up to 288 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 7 to 10 days
|
AEs will be recorded through spontaneous reporting
|
7 to 10 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vital Signs composite measure
Time Frame: 0-288 hours
|
Vital signs are collected as a composite measure- blood pressure, pulse rate, tympanic temperature, respiration rate, SpO2
|
0-288 hours
|
Clinical Laboratory Tests
Time Frame: Day 0 and Day 7-10
|
Blood samples will be taken at screening, pre dose, 192 hours, and post study medical for routine blood chemistry and urinalysis
|
Day 0 and Day 7-10
|
ECG
Time Frame: Screening, pre dose, 72, 120, 168hours, and day 7-10
|
ECGs
|
Screening, pre dose, 72, 120, 168hours, and day 7-10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ACTUAL)
August 1, 2014
Study Completion (ACTUAL)
August 1, 2014
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
June 9, 2014
First Posted (ESTIMATE)
June 10, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BUP1506
- 2014-000691-26 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Second generation BTDS patch
-
Seattle Children's HospitalRecruitingSoft Tissue Sarcoma | Carcinoma | Osteosarcoma | Ewing Sarcoma | Rhabdoid Tumor | Neuroblastoma | Retinoblastoma | Rhabdomyosarcoma | Wilms Tumor | Hepatoblastoma | Synovial Sarcoma | Desmoplastic Small Round Cell Tumor | Germ Cell Tumor | Pediatric Solid Tumor | Clear Cell Sarcoma | Malignant Peripheral Nerve Sheath TumorsUnited States
-
Changhai HospitalCompleted
-
Massachusetts General HospitalWithdrawn
-
University of Texas Southwestern Medical CenterM.D. Anderson Cancer CenterActive, not recruitingObese | Endotracheal Tube | Laryngeal Mask AirwayUnited States
-
Société Française d'Endoscopie DigestiveCompletedColonic Polyp | Colonoscopy | Colonic AdenomaFrance
-
Wuhan Sian Medical Technology Co., LtdWuhan Union Hospital, China; Xiangyang Central Hospital; Jingzhou Central Hospital and other collaboratorsRecruitingB Cell Lymphoma | Acute Lymphoblastic LeukemiaChina
-
Yiqi DuUnknown
-
Wuhan Sian Medical Technology Co., LtdWuhan Union Hospital, China; Xiangyang Central Hospital; Jingzhou Central Hospital and other collaboratorsUnknownB Cell Lymphoma | Acute Lymphoblastic LeukemiaChina
-
Microvention-Terumo, Inc.Semmes-Murphey FoundationRecruiting
-
Wuhan Sian Medical Technology Co., LtdWuhan Union Hospital, China; Xiangyang Central Hospital; Jingzhou Central Hospital and other collaboratorsUnknownB Cell Lymphoma | Acute Lymphoblastic LeukemiaChina