Condition or disease | Intervention/treatment | Phase |
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Elderly Study Participants Adult Study Participants | Drug: Padsevonil | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | An Open-Label, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study of Single and Multiple Oral Administrations of Padsevonil in Adult and Elderly Study Participants |
Actual Study Start Date : | July 9, 2019 |
Actual Primary Completion Date : | October 3, 2019 |
Actual Study Completion Date : | October 3, 2019 |
Arm | Intervention/treatment |
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Experimental: Adult study participants
Participants will receive assigned single and multiple doses of padsevonil.
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Drug: Padsevonil
Padsevonil will be administered in predefined dosages.
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Experimental: Elderly study participants
Participants will receive assigned single and multiple doses of padsevonil.
|
Drug: Padsevonil
Padsevonil will be administered in predefined dosages.
|
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Up0053 001 | |
San Antonio, Texas, United States, 78209 |
Study Director: | UCB Cares | 001 844 599 2273 (UCB) |
Tracking Information | |||||
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First Submitted Date ICMJE | July 5, 2019 | ||||
First Posted Date ICMJE | July 9, 2019 | ||||
Last Update Posted Date | November 13, 2020 | ||||
Actual Study Start Date ICMJE | July 9, 2019 | ||||
Actual Primary Completion Date | October 3, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Test the Safety and Tolerability of Single and Multiple Doses of Padsevonil in Adult and Elderly Study Participants | ||||
Official Title ICMJE | An Open-Label, Parallel-Group, Pharmacokinetic, Safety and Tolerability Study of Single and Multiple Oral Administrations of Padsevonil in Adult and Elderly Study Participants | ||||
Brief Summary | The purpose of the study is to evaluate the plasma pharmacokinetic of padsevonil in adult and elderly study participants. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE | Drug: Padsevonil
Padsevonil will be administered in predefined dosages.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
28 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | October 3, 2019 | ||||
Actual Primary Completion Date | October 3, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04013191 | ||||
Other Study ID Numbers ICMJE | UP0053 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | UCB Pharma ( UCB Biopharma S.P.R.L. ) | ||||
Study Sponsor ICMJE | UCB Biopharma S.P.R.L. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | UCB Pharma | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |