Buprenorphine Transdermal Patches Pharmacokinetic Study

NCT03975010 | Unknown Phase 1

• 1 other identifier: BUP14-CN-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomised, single-dose, 3 arms study design.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

• To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_Cmax

  Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).

  from Day0 to Day8 or Day9

• To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_AUCt

  Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).

  from Day0 to Day8 or Day9

• To evaluate the pharmacokinetic profile of buprenorphine and its primary metabolite, norbuprenorphine_AUCinf

  Pharmacokinetic parameters of the prototype buprenorphine, and the primetabolite norbuprenorphine, calculated from plasma concentration-time data following a single application of BUP TDS 20 mg (3 days), 40 mg (3 days) and 40 mg (4 days).

  from Day0 to Day8 or Day9

Study Arms (3)

BUP TDS 20 mg for 3 days

EXPERIMENTAL

Subjects will be randomized into the arms, use BUP TDS 20 mg for 3 days.

Drug: Buprenorphine Transdermal Patch

BUP TDS 40 mg for 3 days

EXPERIMENTAL

Subjects will be randomized into the arms, use BUP TDS 40 mg for 3 days.

Drug: Buprenorphine Transdermal Patch

BUP TDS 40 mg for 4 day

EXPERIMENTAL

Subjects will be randomized into the arms, use BUP TDS 40 mg for 4 days.

Drug: Buprenorphine Transdermal Patch

Interventions

Buprenorphine Transdermal Patch DRUG

This is an open-label, randomised, single-dose, 3 arms study design. Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days. Safety follow-up will be planned at 7\~9 days after patch removal. The study patch will be applied under the cover of naltrexone to reduce opioid related side-effects. Naltrexone 50 mg will be taken orally every 12 hours, from the evening of Day 00 (13 hours prior to IMP application), until the evening of the patch removal.

Also known as: Naltrexone Hydrochloride

BUP TDS 20 mg for 3 days; BUP TDS 40 mg for 3 days; BUP TDS 40 mg for 4 day

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese male or female subjects with chronic pain (regardless of the aetiology, cancer-pain excluded), aged 18-55 years (both inclusive).
• The average pain over the last 24 hours should attain ≤ 3 assessed with Numeric Rating Scales (NRS) refer to section 19.5. The pain condition has been lasting for at least 1 month and stable for 7 days prior to entering into the screening and is expected to be stable during the study duration.
• Patients on stable permissible non-opioid analgesics, who in the opinion of the investigator are unlikely to require a change in treatment during the study.
• Karnofsky score of Performance Status ≥ 70.
• Body mass index (BMI) of 19 to 28 kg/m2 (both inclusive); and a total body weight ≥ 50 kg.
• Normal dietary habits (e.g. not vegetarian nor vegan) and willing to only take the food supplied during the period of hospitalization.
• Subjects who are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements.
• Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Male subjects (surgical history of bilateral vasectomy excluded) with a partner of child bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study.

You may not qualify if:

• Unstable condition of the primary disease of chronic pain, which, in the opinion of the investigator, would complicate the subject's participation in the study (e.g. require initiation of new medication).
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
• History of seizures or at risk (i.e. head trauma, epilepsy in family, anamnesis, unclear loss of consciousness).
• Any history of frequent nausea or emesis regardless of aetiology.
• Malignancy or a history of malignancy.
• History of orthostatic hypotension.
• Subjects who have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
• Positive results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV Ab), human immunodeficiency virus antibodies (HIVAb).
• Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, benzodiazepines, phencyclidine, methamphetamine, or cannabinoids or alcohol breath test is positive.
• Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors. Alcohol abuse is defined as regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
• Consumption of alcoholic beverages within 48 hours before patch application, and / or refusal to abstain from alcohol throughout the study until at least 48 hours after patch removal.
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• Use of any medicinal product which inhibits CYP3A4 (e.g. troleandomycin, ketoconazole, gestodene, etc) or induces CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin,etc) within 4 weeks prior to first patch administration.
• Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the first patch administration.
• Subjects taking monoamine oxidase (MAO) inhibiters within the past 14 days prior to the first patch administration

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

Study Sites (1)

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Wenping Wang, PhD

  Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Di Yang, Bachelor

CONTACT

86 10 65636798; Di.Yang@mundipharma.com.cn

Rongna A, Master

CONTACT

86 10 65636885; Rongna.A@mundipharma.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 5, 2019
• Study Start: May 13, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

CN (1)