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

NCT02663999 | Completed Phase 1

• 1 other identifier: DZNS-PK-1034
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

dose proportionality; diazepam nasal spray

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

  from 5 minutes up to 24 hours post-dose

Study Arms (2)

diazepam nasal spray (AB)

EXPERIMENTAL

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 (BA)

EXPERIMENTAL

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

Interventions

diazepam nasal spray DRUG

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.

Also known as: PLUMIAZ™ (diazepam) Nasal Spray

diazepam nasal spray (AB); diazepam nasal spray (BA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (1)

Site #001

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Diazepam; Nasal Sprays

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• David Squillacote, MD

  Acorda Therapeutics

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

US (1)