Odalasvir
DrugParticipants will receive odalasvir 25 mg tablet, orally.
NCT Number: NCT02961660
The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Orlando, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cohorts 1 and 2:
Cohort 1:
Cohort 2:
Exclusion criteria
Cohorts 1 and 2:
Cohort 1:
Participants will receive odalasvir 25 mg tablet, orally.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The Cmax is the maximum observed plasma analyte concentration.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
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(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Time frame: Predose and 1, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 60, 72, 96 120, 144, 168, and 312 hours postdose
The CL/F is defined as Dose/AUC (0-infinity).
Time frame: Baseline, up to follow-up (30 to 35 days after study drug intake)
Janssen Research & Development, LLC
Industry
An Open-label Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
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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