Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl

NCT ID: NCT02470390

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-04-30

Brief Summary

A partially randomized, open-label, 3-way crossover, single-center, systemic and CSF PK and bioavailability study in healthy volunteers.

Detailed Description

An Open-Label Single-Dose Crossover Study Comparing the Plasma and Cerebrospinal Fluid Pharmacokinetics and Bioavailability of Fentanyl Delivered Intranasally Versus Sublingually Versus Intravenously in Healthy Volunteers

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nasal fentanyl

nasal fentanyl, 200 μg, administered as one 100 μg spray (100 μL) to each nostril; both completed within one minute.

Will be administered on either study day 1 or 3 per protocol and randomization.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

Sub-Lingual fentanyl

sublingual fentanyl, 200 μg, administered as a single spray (100 μL) under the tongue.

Will be administered on either study day 1 or 3 per protocol and randomization.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

IV fentanyl

IV fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes.

Will be administered on study day 5 per protocol.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

Interventions

Fentanyl

Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl

Intervention Type: DRUG

Other Intervention Names

Lazanda, Subsys, IV fentanyl

Eligibility Criteria

Inclusion Criteria

• Normal healthy male or female between the ages of 18 to 65 years. Never smokers or Non-smokers (cessation of smoking ≥ 6 months ago). Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 32.0 kg/m2.

No clinically meaningful findings in the physical examination, oral and nasal examination and 12-lead electrocardiogram.

Negative for drugs of abuse, alcohol, and nicotine. Negative for hepatitis A, B, and C and Human Immunodeficiency Virus (HIV). No clinical laboratory values outside of the acceptable range, unless, in the opinion of the Principal Investigator, they are deemed not clinically significant.

Exclusion Criteria

• Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to opioids, fentanyl or components of the study drugs.

2. Subjects with a high potential for opioid addiction (personal or family history).

3. Subject is lactating or considered at risk of pregnancy. 4. Subject has impaired liver function (e.g., alanine aminotransferase [ALT] ≥ 3 times the upper limit of normal [ULN] or bilirubin ≥ 3 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral diclofenac exposure.

5. Subject has any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject has significantly impaired renal function as evidenced by an estimated GFR of ≤60 ml/min/1.73m2.

6. Subject has a history or evidence of significant nasal pathology, including polyps or nasal obstructions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Depomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Head of R&D

Role: STUDY_DIRECTOR

Depomed

Other Identifiers

LAZA-PK-401

Identifier Type: -

Identifier Source: org_study_id