A Dose Proportionality and Bioavailability Assessment of Buprenorphine Transdermal Delivery System Second Generation Patches

NCT02160067 | Completed Phase 1

• 2 other identifiers: BUP15062014-000691-26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Healthy Volunteers; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics parameters

  AUC and Cmax

  Up to 288 hours

Secondary Outcomes (1)

• Adverse events

  7 to 10 days

Other Outcomes (3)

• Vital Signs composite measure

  0-288 hours

• Clinical Laboratory Tests

  Day 0 and Day 7-10

• ECG

  Screening, pre dose, 72, 120, 168hours, and day 7-10

Study Arms (4)

Treatment A

EXPERIMENTAL

Second generation patch BTDS 12.6mg

Drug: Second generation BTDS patch

Treatment B

EXPERIMENTAL

Second generation patch BTDS 3.15mg

Drug: Second generation BTDS patch

Treatment C

ACTIVE COMPARATOR

First generation patch BuTrans 20mg

Drug: First generation BuTrans patch

Treatment D

ACTIVE COMPARATOR

First generation patch BuTrans 5mg

Drug: First generation BuTrans patch

Interventions

Second generation BTDS patch DRUG

Treatment A; Treatment B

First generation BuTrans patch DRUG

Treatment C; Treatment D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (1)

Quotient Clinical Ltd

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 10, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-06

Locations

GB (1)