A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

A Two-Period, Randomized, Open-Label, Crossover Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: diazepam nasal spray

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Site #001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Screening body weight 88 to 111 kg, inclusive;
• General good health with no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, visual evaluation of the septum and turbinates to document baseline anatomy, electrocardiogram, clinical laboratory test results;
• Negative drug and alcohol testing;
• Negative pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

• Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
• In the judgment of the Investigator, any clinically significant abnormality (such as septal perforations) or illness that would interfere with participation in this study as determined by medical history, physical examination (including visual exam of septum and turbinates), ECG, clinical laboratory results, or other screening safety tests;
• Any other condition and/or situation that causes the investigator to deem a subject unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diazepam nasal spray (AB); Each subject will receive two single doses of investigational product (DL1, DL2) with a 14-day washout between the doses. The order in which the doses are administered will be randomized, with subjects assigned to 1 of 2 treatment sequences: DL1 (A) followed by DL2 (B), or the reverse order (BA).	Drug: diazepam nasal spray; diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.; Other Names: PLUMIAZ™ (diazepam) Nasal Spray
Experimental: diazepam nasal spray (BA); Each subject will receive two single doses of investigational product (DL1, DL2) with a 14-day washout between the doses. The order in which the doses are administered will be randomized, with subjects assigned to 1 of 2 treatment sequences: DL1 (A) followed by DL2 (B), or the reverse order (BA).	Drug: diazepam nasal spray; diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.; Other Names: PLUMIAZ™ (diazepam) Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum measured plasma concentration (Cmax)	within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24)	within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Area under the concentration curve from time 0 to infinity (AUCinf)	within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Apparent total body clearance of drug from plasma (CL/F)	within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events (AEs) including serious AEs		up to 21 days
Change in focused nasal exam		within 30 minutes prior to dosing and at specified time points up to 24 hours post-dose
Taste change questionnaire	If patient reports a change in taste associated with diazepam nasal spray, questionnaire to be completed by research staff.	from 5 minutes up to 24 hours post-dose

Collaborators and Investigators

• Sponsor: Acorda Therapeutics
• Investigators: Study Director: David Squillacote, MD, Acorda Therapeutics

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: dose proportionality; diazepam nasal spray
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: DZNS-PK-1034