NCT01514968

Brief Summary

This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

January 16, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC)

    16 time points up to 96 hours

Secondary Outcomes (2)

  • Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine

    16 time points up to 96 hours

  • Safety: Incidence of adverse events

    approximately 50 days

Study Arms (3)

DNV/r+cyclosporine

EXPERIMENTAL
Drug: cyclosporineDrug: danoprevirDrug: ritonavir

cyclosporine

ACTIVE COMPARATOR
Drug: cyclosporine

danoprevir+ritonavir

ACTIVE COMPARATOR
Drug: danoprevirDrug: ritonavir

Interventions

cyclosporineDRUG

Single oral dose

DNV/r+cyclosporinecyclosporine
danoprevirDRUG

Single oral dose

DNV/r+cyclosporinedanoprevir+ritonavir
ritonavirDRUG

Single oral dose

DNV/r+cyclosporinedanoprevir+ritonavir

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female healthy volunteers, 18 to 45 years of age inclusive
  • Body mass index (BMI) 18.0 to 32.0 kg/m2
  • Weight \>/= 50 kg
  • Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
  • Nonsmoker
  • Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)

You may not qualify if:

  • Pregnant or lactating females
  • Positive results for drugs of abuse in the urine at screening or prior to admission to the clinical site during any study period
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Current smokers or subjects who have discontinued smoking less than 6 months prior to the first dose of study medication
  • Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
  • Routine chronic use of more than 2 g acetaminophen daily
  • Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
  • History of clinically significant disease or disorder
  • History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
  • History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

  • Brennan BJ, Moreira SA, Morcos PN, Navarro MT, Asthappan J, Goelzer P, Weigl P, Smith PF. Pharmacokinetics of a three-way drug interaction between danoprevir, ritonavir and the organic anion transporting polypeptide (OATP) inhibitor ciclosporin. Clin Pharmacokinet. 2013 Sep;52(9):805-13. doi: 10.1007/s40262-013-0077-2.

    PMID: 23712757DERIVED

MeSH Terms

Interventions

CyclosporinedanoprevirRitonavir

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 23, 2012

Study Start

December 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)