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Completed

NCT Number: NCT01654211

A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Danoprevir

Drug

single iv infusion

Placebo

Drug

single iv infusion

Ritonavir

Drug

oral doses

Primary outcomes

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

    Time frame: Pre-dose and up to 12 hours post-dose

  2. Safety: Incidence of adverse events

    Time frame: approximately 7 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Three-Part Study Evaluating the Pharmacokinetics of Intravenous (IV) Danoprevir (DNV)/Oral Low-Dose Ritonavir (RTV), the Absolute Bioavailability of DNV With and Without Oral Low-Dose RTV, and the Effect of Oral Cyclosporine on IV DNV/Oral Low-Dose RTV in Healthy Adult Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 31, 2012
Registry last updated
Nov 2, 2016

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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