NCT01418274

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

July 20, 2011

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

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

    Approximately 4 weeks

Secondary Outcomes (3)

  • Safety: Incidence of adverse events

    Approximately 6 weeks

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

    Approximately 4 weeks

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

    Approximately 4 weeks

Study Arms (1)

Single arm

EXPERIMENTAL
Drug: danoprevirDrug: escitalopramDrug: ritonavir

Interventions

danoprevirDRUG

oral doses of danoprevir

Single arm
escitalopramDRUG

oral doses of escitalopram

Single arm
ritonavirDRUG

oral doses of ritonavir

Single arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

danoprevirEscitalopramRitonavir

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2011

First Posted

August 17, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)