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Clinical Trial Details

Trial ID: L0635
Source ID: NCT03947814
Associated Drug: Pimodivir
Title: A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: Pimodivir
Outcome Measures: Primary: Maximum Observed concentration (Cmax) of Pimodivir, Cmax is the maximum observed concentration., Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6|Area Under Curve From Time of Dosing to the Time of the last Measurable Concentration (AUC[0-last]) of Pimodivir, AUC(0-last) is the AUC from time of dosing to the time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation., Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6|AUC from time of dosing to infinity (AUC[0-infinity]) of Pimodivir, AUC(0-infinity) is the AUC from time of dosing to infinity, calculated as AUC(0-last) + Clast/ (lambda\[z\]), where Clast is the last observed measurable concentration and lambda(z) is the apparent terminal elimination rate constant., Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose on Day 6 | Secondary: Number of Participants with Adverse Events as a Measure of Safety and Tolerability, 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., Up to 42 (+/-) 2 days
Sponsor/Collaborators: Sponsor: Janssen-Cilag International NV
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 29
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2019-07-02
Completion Date: 2020-09-09
Results First Posted:
Last Update Posted: 2025-02-03
Locations: CRS Clinical Research Services Kiel GmbH, Kiel, 24105, Germany|APEX GmbH, Munchen, 81241, Germany
URL: https://clinicaltrials.gov/show/NCT03947814