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Completed

NCT Number: NCT01418274

A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers

This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.

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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

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult healthy volunteers, aged 18 to 55 years, inclusive
  • Body mass index (BMI) 18.0 to 32.0 kg, inclusive
  • Absence of evidence of any active or chronic disease
  • Non-smokers

Exclusion criteria

  • Presence of any active or chronic disease
  • Abnormal blood pressure
  • Abnormal resting heart rate
  • Abnormal ECG values
  • History of any clinically significant cardiovascular or cerebrovascular disease

Treatment and study plan

Danoprevir

Drug

oral doses of danoprevir

Escitalopram

Drug

oral doses of escitalopram

Ritonavir

Drug

oral doses of ritonavir

Primary outcomes

  1. Change in area under the plasma concentration time curve (AUC) of escitalopram

    Time frame: Approximately 4 weeks

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: Approximately 6 weeks

  2. Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram

    Time frame: Approximately 4 weeks

  3. Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2011
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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