Up0101 101
Anaheim, California, 92801, United States
NCT Number: NCT04782388
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of Staccato alprazolam in healthy Japanese, Chinese, and Caucasian participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study participants will receive Staccato alprazolam at prespecified time-point.
Other names: UCB7538
Study participants will receive Staccato placebo at prespecified time-point.
Other names: PBO
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. The occurrence and incidence of TEAEs will also be summarized by intensity and by relationship to the investigational medicinal product (IMP).
Time frame: From Baseline to the end of the Safety-Follow-Up (up to Day 10)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Cmax = Maximum plasma concentration.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Cmax = Maximum plasma concentration.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
Cmax = Maximum plasma concentration.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUClast = Area under the plasma concentration-time curve from time 0 to the last measurable concentration.
Time frame: Plasma samples will be collected on predose within 30 minutes prior to dosing, at 1 minute, 2 minutes, 5 minutes, 10 minutes, and 30 minutes and at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours postdose
AUCinf = Area under the plasma concentration-time curve from time 0 to infinity.
UCB Biopharma SRL
Industry
A Placebo-Controlled, Double-blind, Randomized Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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