Clinical trial NCT02663999: A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
Official title: A Two-Period, Randomized, Open-Label, Crossover Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: dose proportionality
diazepam nasal spray
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum measured plasma concentration (Cmax)
timeFrame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
measure: Area under the concentration curve from time 0 to the concentration at 24 hours (AUC0-24)
timeFrame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
measure: Area under the concentration curve from time 0 to infinity (AUCinf)
timeFrame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
measure: Apparent total body clearance of drug from plasma (CL/F)
timeFrame: within 15 minutes prior to dosing and at specified time points up to 24 hours post-dose
Secondary outcomes:
measure: Number of patients with adverse events (AEs) including serious AEs
timeFrame: up to 21 days
measure: Change in focused nasal exam
timeFrame: within 30 minutes prior to dosing and at specified time points up to 24 hours post-dose
measure: Taste change questionnaire
timeFrame: from 5 minutes up to 24 hours post-dose
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Site #001
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: David Squillacote, MD
role: STUDY_DIRECTOR
References: