Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and a Pharmacokinetic Enhancer When Administered in Combination in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 11/30/-0001 |
| Start Date: | May 2013 |
| Contact: | John Z Sullivan-Bolyai, MD |
| Email: | clinicaltrials@idenix.com |
| Phone: | 877-433-6491 |
A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and a Pharmacokinetic Enhancer When Administered in Combination in Healthy Subjects
The purpose of this study is to evaluate the potential for a PK drug-drug interaction when
IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination.
Safety and tolerability will also be assessed.
Inclusion Criteria:
- Read and signed the written informed consent form (ICF) after the nature of the study
has been fully explained.
- All subjects of childbearing potential must have agreed to use a double method of
birth control (one of which must be a barrier) from Screening through at least 90
days after the last dose of the study drug.
- Male subjects have agreed not to donate sperm from Day -1 through 90 days after the
last dose of study drug.
Exclusion Criteria:
- Pregnant or breastfeeding.
- Other clinically significant medical conditions or laboratory abnormalities.
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