Phase 1 N=36 Treatment

Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment

Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT01830205 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir — 11215.264; 21261.199; 24789.951; 21946.450 nanograms*hours/milliliter (ng*h/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Daclatasvir (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir	11215.264; 21261.199; 24789.951; 21946.450; 14257.489	—
SECONDARY Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir	83.845; 128.157; 144.915; 139.576; 100.736	—
SECONDARY Maximum Observed Plasma Concentration (Cmax) of Daclatasvir	1111.497; 1619.572; 1745.845; 1207.137; 1085.344	—
SECONDARY Unbound Maximum Observed Plasma Concentrations of Daclatasvir	8.309; 9.762; 10.206; 7.677; 7.668	—
SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir	11092.967; 20852.129; 24343.711; 21238.909; 13934.562	—
SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir	1.000; 1.250; 1.000; 1.500; 1.250	—
SECONDARY Plasma Half-life (T-half) of Daclatasvir	13.625; 15.661; 16.912; 20.224; 15.678	—
SECONDARY Apparent Total Body Clearance (CLT/F) of Daclatasvir	89.164; 47.034; 40.339; 45.565; 70.139	—
SECONDARY Unbound Apparent Clearance (CLU/F) of Daclatasvir	11926.796; 7802.955; 6900.602; 7164.575; 9926.962	—
SECONDARY Percent Urinary Recovery (%UR) of Daclatasvir	5.007; 5.820; 3.530; 2.658; 0.199	—
SECONDARY Renal Clearance (CLR) of Daclatasvir	4.465; 2.737; 1.424; 1.165; 0.147	—
SECONDARY Apparent Volume of Distribution (Vd/F) of Daclatasvir	105.157; 63.761; 59.054; 79.769; 95.186	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events	0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events	0; 0; 0; 0	—
SECONDARY Number of Participants With Out-of-range Vital Signs Reported as Adverse Events	0; 0; 0; 1	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Meet renal function criteria in one of four categories

Exclusion Criteria

Unstable or uncontrolled medical conditions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01830205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.