Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830205

AI444-063

Details and patient eligibility

About

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

Full description

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

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet renal function criteria in one of four categories

Exclusion criteria

• Unstable or uncontrolled medical conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

Group A (Normal renal function): Daclatasvir

Experimental group

Description:

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Treatment:

Drug: Daclatasvir

Group B (End Stage Renal Disease): Daclatasvir

Experimental group

Description:

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Treatment:

Drug: Daclatasvir

Group C (Moderate renal impairment): Daclatasvir

Experimental group

Description:

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Treatment:

Drug: Daclatasvir

Group D (Severe renal impairment): Daclatasvir

Experimental group

Description:

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Treatment:

Drug: Daclatasvir