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A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteer

Intervention: danoprevir (Drug); raltegravir (Drug); ritonavir (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This open-label, multiple dose, single sequence crossover study will evaluate the drug-drug interaction between danoprevir/low-dose ritonavir and raltegravir in healthy volunteers. Subjects will receive raltegravir on Days 1-4 and, after a washout period of 3 days, danoprevir and low-dose ritonavir on Days 8-21, in combination with raltegravir on Days 18-21.

Clinical Details

Official title: A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Effect of steady-state ritonavir-boosted danoprevir on steady-state raltegravir pharmacokinetics: Area under the concentration-time curve (AUC)

Secondary outcome:

Effect of steady-state raltegravir on danoprevir/ritonavir pharmacokinetics: Area under the concentration-time curve (AUC)

Safety: Incidence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive

- Healthy status defined by absence of evidence of any active or chronic disease

- Medical history without major, recent, or ongoing pathology

- Weight >/= 50. 0 kg

- Body mass index (BMI) 18. 0 - 32-0 kg/m2

- Willingness to abstain from alcohol, xanthine-containing beverages or food (e. g.

coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the clinical site until discharge

- Females of child-bearing potential and males and their female partners of

child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide Exclusion Criteria:

- Pregnant or lactating females or males with female partners who are pregnant or

lactating

- Any history of clinically significant cardiovascular or cerebrovascular disease,

hypertension, and/or infections

- Positive test 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

- Current smokers or subjects who have discontinued smoking less than 6 months prior to

first dose of study medication

- Use of hormonal contraceptives within 30 days before the first dose of study

medication

- History of clinically significant drug-related allergy (such as anaphylaxis) or

hepatotoxicity

Locations and Contacts

Lenexa, Kansas 66219, United States
Additional Information

Starting date: January 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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