BPN14770
DrugBPN14770 will be administered per schedule specified in the arm description.
NCT Number: NCT07012005
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 1
Division of Clinical Pharmacology, University of Miami, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All Participants:
Participants With Renal Impairment:
a. Severe renal impairment: eGFR <30 milliliters (mL)/minute (min)
Healthy Participants:
Exclusion criteria
All Participants:
Participants With Renal Impairment:
NOTE: Other protocol-specified inclusion and exclusion criteria may apply.
BPN14770 will be administered per schedule specified in the arm description.
Time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Time frame: Day 1 up to Day 15
Shionogi
Industry
A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of BPN14770 in Participants With Severe Renal Impairment and Healthy Control 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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