A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers

INSYS Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection; Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection; Drug: Treatment A: Naloxone Nasal Spray; Drug: Treatment B: Naloxone Nasal Spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03827642

INS012-18-119

Details and patient eligibility

About

The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A minimum body weight of 50 kg. Body mass index (BMI) between 18.0 and 32.0 kg/m2
• A seated blood pressure between 90 and 140 mmHg systolic/50 and 90 mmHg diastolic
• Female subjects had a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test at screening

Exclusion criteria

• A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients
• Any documented clinically significant infection, injury, or illness within 1 month prior to screening
• An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening
• A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening
• A positive urine test result for alcohol, drugs, or cotinine at screening or check-in
• A condition that the investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk
• Used any opioids for 30 days prior to Day 1
• Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
• Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Cohort 1: Treatment Sequence A-D-C-B

Experimental group

Description:

Participants received Treatment A on Day 1 of Period 1, Treatment D on Day 1 of Period 2, Treatment C on Day 1 of Period 3 and Treatment B on Day 1 of Period 4.

Treatment:

Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection

Drug: Treatment B: Naloxone Nasal Spray

Drug: Treatment A: Naloxone Nasal Spray

Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection

Cohort 2: Treatment Sequence B-C-D-A

Experimental group

Description:

Participants received Treatment B on Day 1 of Period 1, Treatment C on Day 1 of Period 2, Treatment D on Day 1 of Period 3 and Treatment A on Day 1 of Period 4.

Treatment:

Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection

Drug: Treatment B: Naloxone Nasal Spray

Drug: Treatment A: Naloxone Nasal Spray

Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection

Cohort 3: Treatment Sequence C-A-B-D

Experimental group

Description:

Participants received Treatment C on Day 1 of Period 1, Treatment A on Day 1 of Period 2, Treatment B on Day 1 of Period 3 and Treatment D on Day 1 of Period 4.

Treatment:

Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection

Drug: Treatment B: Naloxone Nasal Spray

Drug: Treatment A: Naloxone Nasal Spray

Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection

Cohort 4: Treatment Sequence D-B-A-C

Experimental group

Description:

Participants received Treatment D on Day 1 of Period 1, Treatment B on Day 1 of Period 2, Treatment A on Day 1 of Period 3 and Treatment C on Day 1 of Period 4.

Treatment:

Drug: Treatment D: Naloxone HCl Intramuscular (IM) Injection

Drug: Treatment B: Naloxone Nasal Spray

Drug: Treatment A: Naloxone Nasal Spray

Drug: Treatment C: Naloxone HCl Intravenous (IV) Injection