A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants

Phase 1

Waitlist Available

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial compares how well the body absorbs alprazolam when taken by mouth versus when inhaled. It involves individuals who need to take alprazolam and measures the amount of medication in the bloodstream. Alprazolam is commonly used to treat anxiety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) of treatment period 1 to the end of safety follow-up (up to 25 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the plasma concentration-time curve from time 0 to infinity (AUC) of alprazolam

Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of alprazolam

Maximum plasma concentration (Cmax) of alprazolam

Secondary study objectives

Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs)

Percentage of study participants with treatment-emergent adverse events (TEAEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Sequence BAExperimental Treatment2 Interventions

Study participants randomized into this arm will receive single dose of oral alprazolam followed by single dose of Staccato alprazolam at pre-specified time points in the sequence BA.

Group II: Treatment Sequence ABExperimental Treatment2 Interventions

Study participants randomized into this arm will receive single dose of Staccato alprazolam followed by single dose of oral alprazolam at pre-specified time points in the sequence AB.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Staccato alprazolam

2022

Completed Phase 1

~30

Oral alprazolam

2011

Completed Phase 3

~250