Healthy
Conditions
Keywords
dose proportionality, diazepam nasal spray
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
Interventions
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.
Sponsors
Acorda Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | If patient reports a change in taste associated with diazepam nasal spray, questionnaire to be completed by research staff. |
| Number of patients with adverse events (AEs) including serious AEs | up to 21 days | — |
Countries
United States
Outcome results
None listed