Pimodivir
DrugParticipants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other names: JNJ-63623872
NCT Number: NCT03816631
The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 1
CRS Clinical Research Services Kiel GmbH, Kiel, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
Other names: JNJ-63623872
Time frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)
Cmax is defined as maximum observed analyte concentration of pimodivir.
Time frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)
AUC(last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of Pimodivir calculated by linear-linear trapezoidal summation.
Time frame: Predose, 30 min, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 120 hours post dose and end of study (up to Day 14)
The AUC ([0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Approximately 42 days
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Janssen-Cilag International NV
Industry
A Phase 1, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Orally Administered Pimodivir in Adult Subjects
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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