A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

NCT01654211 | Completed Phase 1

• 2 other identifiers: NP282972012-000470-40
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This three-part study will evaluate the pharmacokinetics and bioavailability of intravenous danoprevir with and without low-dose oral ritonavir, and the effect of oral cyclosporine on the pharmacokinetics of intravenous danoprevir with ritonavir in healthy volunteers.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  Pre-dose and up to 12 hours post-dose

• Safety: Incidence of adverse events

  approximately 7 months

Study Arms (7)

Part 1: iv danoprevir

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Part 1: placebo

PLACEBO COMPARATOR

Drug: placebo; Drug: ritonavir

Part 2 A: iv danoprevir

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Part 2 B: oral danoprevir

ACTIVE COMPARATOR

Drug: danoprevir; Drug: ritonavir

Part 2 C: ritonavir

ACTIVE COMPARATOR

Drug: ritonavir

Part 3 D: iv danoprevir

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Part 3 E: iv danoprevir + cyclosporine

EXPERIMENTAL

Drug: danoprevir; Drug: ritonavir

Interventions

danoprevir DRUG

single iv infusion

Part 1: iv danoprevir; Part 2 A: iv danoprevir; Part 3 D: iv danoprevir; Part 3 E: iv danoprevir + cyclosporine

placebo DRUG

single iv infusion

Part 1: placebo

ritonavir DRUG

oral doses

Part 1: iv danoprevir; Part 1: placebo; Part 2 A: iv danoprevir; Part 2 B: oral danoprevir; Part 2 C: ritonavir; Part 3 D: iv danoprevir; Part 3 E: iv danoprevir + cyclosporine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult healthy male and female nonsmoking volunteers, 18 to 55 years of age inclusive; healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination

You may not qualify if:

• Pregnant or lactating women or males with female partners who are pregnant or lactating
• Positive results for drugs of abuse at screening or prior to admission to the clinical site during any study period
• Positive for hepatitis B, hepatitis C or HIV infection

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

danoprevir; Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)