Clinical trial NCT01830205: Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
Official title: Single Dose Pharmacokinetics and Safety of Daclatasvir in Subjects With Renal Function Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.

Detailed description: Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study

Eligibility criteria: Inclusion Criteria:

- Meet renal function criteria in one of four categories

Exclusion Criteria:

- Unstable or uncontrolled medical conditions

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
Secondary outcomes:
measure: Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Unbound Maximum Observed Plasma Concentrations of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Plasma Half-life (T-half) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Apparent Total Body Clearance (CLT/F) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Unbound Apparent Clearance (CLU/F) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Percent Urinary Recovery (%UR) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Renal Clearance (CLR) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Apparent Volume of Distribution (Vd/F) of Daclatasvir
timeFrame: Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died
timeFrame: First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs
measure: Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events
timeFrame: Baseline up to Day 5 post dose
measure: Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events
timeFrame: Baseline up to Day 5 post dose
measure: Number of Participants With Out-of-range Vital Signs Reported as Adverse Events
timeFrame: Baseline up to Day 5 post dose
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: Davita Clinical Research
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Garimella T, Wang R, Luo WL, Hwang C, Sherman D, Kandoussi H, Marbury TC, Alcorn H, Bertz R, Bifano M. Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment. Antivir Ther. 2015;20(5):535-43. doi: 10.3851/IMP2941. Epub 2015 Feb 5.