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

Depomed

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Fentanyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT02470390

LAZA-PK-401

Details and patient eligibility

About

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

Full 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

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

  4. 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.

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

13 participants in 3 patient groups

Nasal fentanyl

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl

Sub-Lingual fentanyl

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl

IV fentanyl

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl