A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01398293
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 17.2

Study Details

Study Description

Brief Summary

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: danoprevir; Drug: danoprevir; Drug: danoprevir placebo; Drug: moxifloxacin; Drug: moxifloxacin placebo; Drug: ritonavir; Drug: ritonavir placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Official Title: A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: danoprevir; 100 mg single dose orally; Drug: moxifloxacin placebo; single oral dose; Drug: ritonavir; 100 mg single dose orally
Experimental: B	Drug: danoprevir; 400 mg single dose orally; Drug: moxifloxacin placebo; single oral dose; Drug: ritonavir; 100 mg single dose orally
Active Comparator: C	Drug: danoprevir placebo; single oral dose; Drug: moxifloxacin; 400 mg single dose orally; Drug: ritonavir placebo; single oral dose
Placebo Comparator: D	Drug: danoprevir placebo; single oral dose; Drug: moxifloxacin placebo; single oral dose; Drug: ritonavir placebo; single oral dose

Outcome Measures

Primary Outcome Measures

1. Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose [approximately 9 weeks]

Secondary Outcome Measures

1. Pharmacokinetics: Plasma concentrations [approximately 9 weeks]

2. Safety: Incidence of adverse events [approximately 9 weeks]

3. Cardiac response: Electrocardiogram (ECG) [approximately 9 weeks]

4. Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes [approximately 9 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adult healthy volunteers, 18 - 60 years of age

• Female subjects must be surgically sterile or post-menopausal

• Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration

• Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)

Exclusion Criteria:

• History or evidence of any clinically significant disease or disorder

• Pregnant or lactating women

• Male partners of women who are lactating or trying to become pregnant

• Current smokers or subjects who have discontinued smoking less than six months prior to first dosing

• Positive alcohol breath test; suspicion of regular consumption of drugs of abuse

• Positive for hepatitis B, hepatitis C or HIV infection

• Participation in an investigational drug, biologic, or device study within three months before first study drug administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Strasbourg		France	67064

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01398293
• Other Study ID Numbers: NP25298; 2011-001413-13
• First Posted: Jul 20, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Ritonavir; Moxifloxacin; Lactams; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Nov 2, 2016