GLS4/RTV and TAF Drug-drug Interaction (NCT04551261) | Clinical Trial Compass
CompletedPhase 1
GLS4/RTV and TAF Drug-drug Interaction
China28 participantsStarted 2021-01-10
Plain-language summary
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
* Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
* Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.
Exclusion Criteria:
* In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
* Allergic constitution (multiple drug and food allergies);
* A history of alcoholism;
* Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
* Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;
* P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;
* Female subjects are lactating or have positive blood pregnancy results during the screening period;